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Ref. Ares(2018)2987492 - 07/06/2018 Competent Authorities of the EU and EFTA Member States responsible for the implementation of the Directive 2014/90/EU on Marine Equipment (MED) Lisbon, 7 June 2018 Subject: Cost-Effectiveness Analysis of Directive 2014/90/EU on Marine Equipment (MED) Dear Sir/Madam, Within the context of EMSA’s visits to Member States and the task entrusted to EMSA in its Founding Regulation to carry out effectiveness and cost-efficiency analysis of the implementation measures that said Member States put in place, discussions took place with representatives of the Member States during the MED pre-cycle workshop held in Lisbon on 18 May 2017. Based on the outcome, EMSA has developed a cost-effectiveness assessment methodology for the analysis of Member States’ measures to implement Directive 2014/90/EU on Marine Equipment (MED). In this regard, EMSA has also developed a cost-effectiveness analysis (CEA) model as a tool to identify and assess the main cost elements of measures put in place by Member States and the degree of their effectiveness when implementing and enforcing the MED requirements. As a starting point, EMSA has carried out data collection and a pre-assessment analysis of the available information from relevant databases (e.g. RAPEX, ICSMS, MarED, NANDO, etc.) and also from the pre-cycle questionnaires sent to Member States in April 2017, so as to minimise the amount of information that needs to be requested. Following this pre-assessment, a simplified questionnaire has been generated in order to fine tune and complement the available data to support the cost-effectiveness analysis. The questionnaire and the overall cost-effectiveness analysis are not intended to verify any regulatory compliance but rather to provide an overall comparative analysis of the effectiveness of the measures and related costs incurred by Member States when complying with the requirements of the Marine Equipment Directive (cost-effectiveness analysis - CEA) as part of the overall cost-efficiency assessment. Some of the questions require no more than confirmation of the data from the relevant databases (e.g. RAPEX, ICSMS, MarED, NANDO, etc.) and/or from the pre-cycle questionnaires. Other questions do, however, require additional information. Finally, open questions have been included as an opportunity for Member States to convey their expert opinion with a view to gathering further valuable input for the purpose of this exercise. We kindly ask your Services to complete the attached questionnaire and return it to EMSA by 24 August 2018 (by email to: [email protected]). Their active contribution will be essential for the success of this study. Yours faithfully, Manuela Tomassini Head of Department Safety and standards Page 1 of 2 [email protected] Tel +351 21 1209 418 / Fax +351 21 1209 482 EMSA, Praça Europa 4, 1249-206 Lisbon, Portugal / emsa.europa.eu  Annex: Questionnaire for the cost-effectiveness analysis of Member States’ measures to implement the Marine Equipment Directive Page 2 of 2 Electronically signed on 06/06/2018 19:19 (UTC+02) questionnaire for the cost-effectiveness analysis of member states ’ measures to implement the marine equipment directive Directive 2014/90/EU of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC Estonia Introduction Article 3.5 of the EMSA founding regulation provides that “ where appropriate, and in any case when a cycle of visits or inspections is concluded, the Agency shall analyse reports from that cycle with a view to identifying horizontal findings and general conclusions on the effectiveness and cost-efficiency of the measures in place . The Agency shall present this analysis to the Commission for further discussion with Member States in order to draw any relevant lessons and facilitate the dissemination of good working practices .” Moreover, the new M ethodology for V isits to Member States adopted by the EMSA Administrative Board in November 2015 states that “the horizontal findings arising from the cycles of visits to the Member States will serve to analyse areas of common concern in implementation, as well as identify best practices and lessons learnt on the effectiveness and cost efficiency of the measures in place” . As a consequence, EMSA has developed a cost-efficiency assessment methodology for this type of analysis. The A dministrative B oard agreed that this approach should be applied to future visit cycles relating to the implementation of Union Law in November 2016 . This exercise will provide an overall comparative analysis of the c osts incurred by Member States when complying with the requirements of the Marine Equipment Directive (MED) as part of the overall relevant cost-efficiency assessment. It is not intended to verify regulatory compliance. In order to carry out this exercise, EMSA has carried out a preliminary data collection and pre-assessment analysis of the information available from previous EMSA visits, from relevant databases (e.g. RAPEX, ICSMS, MarED , NANDO, etc.) and from the pre-cycle questionnaire sent to each Member State in April 2017 , so as to minimise the request for information. The replies to this questionnaire will be used to confirm and complement the information already available for t he cost-effectiveness analysis. Some of the questions require only confirmation of the data provide d during the EMSA visits and the pre-cycle workshop or collected from relevant data base s . Other questions require additional information. Finally , open questions have been included as an opportunity for you to convey your expert opinion with a view to gather ing further valuable input for the purpose of this exercise. This questionnaire mirrors a process analysis approach under which the standard methodology for carrying out the visits has been developed. Each process involves a compilation of related requirements laid down in the Directive (see Figure 1). These processes organise the requirements by main areas of activity. The following processes have been identified for this cycle of visits in respect of the Directive : Flag State activities: This process includes all the operational MED activities and duties that a Member State has to carry out in its capacity as f lag State. These activities include: ensuring that the marine equipment on board the flag State’s ships complies with the requirements of the MED or alternatively, in the case of a non-EU ship transferring in , is equivalent to the MED standards; not prohibiting the placing on board of marine equipment which complies with the MED; and issuing exemptions under the circumstances defined in the MED. Designation and follow-up of Notified Bodies : This process considers all activities regulated by the articles of the Directiv e that refer to Notified B odies (NBs) and that are carried out by the Notifying Authority (be it a specifically designated authority , the National Accreditation Body or another authorised non-governmental entity). These actions range from the authorisation of NBs to their monitoring and assessment, including all the actions undertaken to notify the Commission of new notifications or changes to existing ones. Market Surveillance and follow-up action : Th is process comprises all articles of the Directive governing the activities of national market surveillance of marine equipment . These activities comprise the designation of market surveillance authorities and related infrastructures, drawing up market surveillance programmes that include check s on pieces of equipment (documentary, on board and sample checks), the identification of specific equipment posing a potential hazard and all the related actions to communicate the outcome of these activities to interested parties. EU-MS cooperation and mutual assistance : This process covers the requirements of the MED for organising all marine equipment standardisation and coordination activities among EU Member States and among NBs , including the exchange of practical experience and participation in specific sectoral working groups. Figure SEQ Figure \* ARABIC 1 - Process breakdown structure of the MED D irective (core application processes in blue; implementation preliminary processes in orange; activities in green) QUESTIONNAIRE Human and financial resources/c osts Question STYLEREF 1 \s 1 . SEQ Question_ \* ARABIC \s 1 1 Having regard to the information reported in the pre-cycle workshop questionnaire sent to your Member State in April 2017, please confirm, amend or provide as necessary the number of full time equivalent staff members on an annual basis who are directly involved in the following processes related to the MED . If the process es’ activities are partly or fully dele gated to non-governmental entities, please indicate your best estimat e o f the number of staff concerned. Definitions: Where the activities (e.g. inspections) carried out in the context of the MED represent only part of the work carried out by the staff involved, the staff must be converted to a number of full-time equivalent officers. Full time equivalents are used to describe the involvement of each staff member in MED activities, for example: A full time officer with 100% of the working time related to MED activities = 1 Full time officer. A part time officer with 20% of the working time related to MED acti vities= 0.2 Full time officer. For those Member States where MED related activities are carried out within other legislative frameworks (e.g. f lag State or p ort State c ontrol activities), this figure should reflect only the working time dedicated to the specific activities which are relevant to the MED . PROCESS No. Full Time (100% duties related to the MED) No. Part Time (Indicate % of the activity related to the MED) Annual Full Time Equivalent Flag State activities governmental entity Click here to enter text. 13 (5%) Click here to enter text. . 0.65 Click here to enter text. . non-governmental entity (e.g. ROs) Click here to enter text. Click here to enter text. Click here to enter text. Designation and follow-up of Notified Bodies governmental entity Click here to enter text. 3 (3%) + 1 (15%) Click here to enter text. . 0.25 Click here to enter text. . non-governmental entity Click here to enter text. Click here to enter text. Click here to enter text. Market Surveillance governmental entity Click here to enter text. 13 (5%) Click here to enter text. . 0.65 Click here to enter text. . non-governmental entity Click here to enter text. Click here to enter text. Click here to enter text. EU-MS cooperation and mutual assistance governmental entity Click here to enter text. 2 (5%) Click here to enter text. . 0.1 Click here to enter text. . Question STYLEREF 1 \s 1 . SEQ Question_ \* ARABIC \s 1 2 Please provide the total annual budget (including administrative and travel costs, planning, etc.) for all the activities concerning the processes related to the MED . If the processes’ activities are partly or fully delegated to non-governmental entities through public funded contracts, please indicate their values. PROCESS Total annual budget (in €) Annual value of public-funded contracts Flag State activities Click here to enter text. Click here to enter text. Designation and follow-up of Notified Bodies Click here to enter text. Click here to enter text. Market Surveillance Click here to enter text. Click here to enter text. EU-MS cooperation and mutual assistance Click here to enter text. Click here to enter text. Question STYLEREF 1 \s 1 . SEQ Question_ \* ARABIC \s 1 3 Please indicate the most expensive specific activities within the above proces ses. In the pre-cycle workshop questionnaire it was reported: ‘ So far no additional costs. But if the number of NBs will rise, we would need additional personnel’. Please provide any further information you deem useful. Click here to enter text. Question STYLEREF 1 \s 1 . SEQ Question_ \* ARABIC \s 1 4 Please provide (if any) additional/extra costs (not mentioned in this questionnaire) which may have an impact on the budgets/expenses related to the implementation of the MED (e.g. adjustment and/or new IT systems, etc.) . Click here to enter text. Question STYLEREF 1 \s 1 . SEQ Question_ \* ARABIC \s 1 5 Please provide the annual person-hours for the following MED key activities/tasks requested to MSs by the D irective. Please differentiate between the person-hours involving staff of public or private entities . Annual person-hours for: Public administrations Non-governmental (private) entities On-board verifications Click here to enter text. Click here to enter text. Desktop analysis (e.g. office-based documents verification, design verification, etc.) Click here to enter text. Click here to enter text. Monitoring and auditing NBs Click here to enter text. Click here to enter text. Performing checks on equipment Documentary verifications Click here to enter text. Click here to enter text. On board checks Click here to enter text. Click here to enter text. Question STYLEREF 1 \s 1 . SEQ Question_ \* ARABIC \s 1 6 Please provide the average number of annual training hours per person for staff inv olved in MED related activities. Training provided and/or attended in EMSA Click here to enter text. Training provided by the national authorities Click here to enter text. FLAG STATE ACTIVITIES Question STYLEREF 1 \s 2 . SEQ Question_ \* ARABIC \s 1 1 Please provide the annual number of verifications related to the MED carried out on-board vessels flying your Flag . 2015 2016 2017 Announced verifications Click here to enter text. Click here to enter text. Click here to enter text. Unannounced verifications Click here to enter text. Click here to enter text. Click here to enter text. Question STYLEREF 1 \s 2 . SEQ Question_ \* ARABIC \s 1 2 How do you select/target the vessels flying your Flag to be subjected to on-board surveys? Click here to enter text. Question STYLEREF 1 \s 2 . SEQ Question_ \* ARABIC \s 1 3 If applicable, do you authorise ROs for MED activities/surveys and, if so, do you include specific references to MED activities in your agreements with these ROs? Click here to enter text. Question STYLEREF 1 \s 2 . SEQ Question_ \* ARABIC \s 1 4 Please provide the number of vessels flying your Flag under the scope of the MED (differentiated between vessels surveyed and certified by governmental or non-governmental entities) . 2015 2016 2017 Surveyed and certified by governmental entities Click here to enter text. Click here to enter text. Click here to enter text. Surveyed and certified by non-governmental entities Click here to enter text. Click here to enter text. Click here to enter text. Total (*Data from the UNCTAD database) 72* Click here to enter text. . 76* Click here to enter text. . 78* Click here to enter text. . Question STYLEREF 1 \s 2 . SEQ Question_ \* ARABIC \s 1 5 If applicable, please describe how non-governmental entities (e.g. ROs, etc.) authorised/responsible for MED related f lag State activities are monitored . Please provide, for example, the annual number of verifications planned and carried out and/or coordination meetings with such private organisations . Click here to enter text. Question STYLEREF 1 \s 2 . SEQ Question_ \* ARABIC \s 1 6 Please indicate if and how do you extend the applicability of the Directive even to vessels flying your Flag but not falling within the scope of the Directive . Click here to enter text. Question STYLEREF 1 \s 2 . SEQ Question_ \* ARABIC \s 1 7 Please provide the following information on identified non-compliances related to MED equipment on-board vessels flying your Flag . 2015 2016 2017 Total annual number of non-compliances Click here to enter text. Click here to enter text. Click here to enter text. Non-compliances related to wheel-mark/documents Click here to enter text. Click here to enter text. Click here to enter text. Non-compliances related to procedures/type approval Click here to enter text. Click here to enter text. Click here to enter text. Operational non-compliances (wrong maintenance or use of the item) Click here to enter text. Click here to enter text. Click here to enter text. Product non-compliances Click here to enter text. Click here to enter text. Click here to enter text. Number of identified counterfeit products Click here to enter text. Click here to enter text. Click here to enter text. Question STYLEREF 1 \s 2 . SEQ Question_ \* ARABIC \s 1 8 Please confirm that the lists of items reported in RAPEX/ICSMS or the lists of the certificates withdrawn, cancelled or temporary suspended from MarED are regularly updated, promptly circulated and properly used during the MED related verifications . Please describe briefly the whole process. Click here to enter text. Question STYLEREF 1 \s 2 . SEQ Question_ \* ARABIC \s 1 9 Please provide the following information related to verifications of MED equipment . Please describe your targeting criteria (if any) to select the items to be subject to verification (e.g. based on a statistical approach) . Click here to enter text. Are all the items of MED equipment verified at each survey? If not, is all the marine equipment fully verified at least once at any stage and then afterwards only items changed, modified and/or suspected are further surveyed? Click here to enter text. Question STYLEREF 1 \s 2 . SEQ Question_ \* ARABIC \s 1 10 Please provide the number of cases in the last 5 years (if any), in which a wheel-marked piece of equipment has been questioned by any MED stakeholder for being placed on board a ship (i.e. number of external complaints and/or warnings received) . Click here to enter text. Question STYLEREF 1 \s 2 . SEQ Question_ \* ARABIC \s 1 11 Please provide the following information related to vessels flying your Flag and transferred from a non - EU country . 2015 2016 2017 Number of non-EU vessels transferred to your Flag State Click here to enter text. Click here to enter text. Click here to enter text. Number of non-compliances of marine equipment on board of non-EU ships transferred to your Flag State Click here to enter text. Click here to enter text. Click here to enter text. Number (if any) of equivalence certificates issued for marine equipment on board of non-EU ships transferred to your Flag State Click here to enter text. Click here to enter text. Click here to enter text. Question STYLEREF 1 \s 2 . SEQ Question_ \* ARABIC \s 1 12 Please describe the difficulties encountered (if any) in transferring non-EU ships to your Flag (e.g. problems in verifying equipment and/or in issuing equivalence certificates, etc.). Please provide also the causes/reasons of such difficulties. Click here to enter text. Question STYLEREF 1 \s 2 . SEQ Question_ \* ARABIC \s 1 13 Please provide the number of requested and the number of granted exemptions for marine equipment on board vessels flying your flag in the last 3 years, classified by category (i.e. for technical innovation - A rt icle 30, for testing or evaluation – A rt icle 31, for exceptional circumstances – A rt icle 32) Number of requested exemptions Number of granted exemptions For technical innovation Click here to enter text. Click here to enter text. For testing or evaluation Click here to enter text. Click here to enter text. For exceptional circumstances Click here to enter text. Click here to enter text. Question STYLEREF 1 \s 2 . SEQ Question_ \* ARABIC \s 1 14 Please provide the average response time to exemptions’ requests (if any), particularly from remote locations . Click here to enter text. Question STYLEREF 1 \s 2 . SEQ Question_ \* ARABIC \s 1 15 Please provide the average duration of approved exemptions (if any) for testing or evaluation ( A rt icle 31 ( b) . Click here to enter text. Question STYLEREF 1 \s 2 . SEQ Question_ \* ARABIC \s 1 16 Please provide the number in the last 3 years (if any) of issued interim certificates ( A rt icle 32 ( 5 ) - ( 7) ) following a demonstration that wheel-marked marine equipment was not available on the market . Please add any further detail you deem useful . Click here to enter text. Question STYLEREF 1 \s 2 . SEQ Question_ \* ARABIC \s 1 17 Please provide the number of requests (if any) by the Commission to withdraw permissions for exemptions granted to marine equipment on board vessels flying your Flag ( A rt icle 30 ( 5 ) or 32 ( 8) ). Click here to enter text. Designation and follow-up of Notified Bodies (NBs) Question STYLEREF 1 \s 3 . SEQ Question_ \* ARABIC \s 1 1 Please provide, confirm or amend as necessary the number of applications for becoming a NB and the related number of granted notifications . Number of applications Number of granted notifications Click here to enter text. 1 (from the MarEd and NANDO databases) Click here to enter text. Question STYLEREF 1 \s 3 . SEQ Question_ \* ARABIC \s 1 2 Please, for each approved NB, confirm or amend as necessary also its name and the number of modules covered by the granted notification . European Agency of Inspecting and Certification OÜ: 4 modules (Modules B,D,F,G) for Live-saving appliances, Navigation equipment and Radio-communication equipment Click here to enter text. Question STYLEREF 1 \s 3 . SEQ Question_ \* ARABIC \s 1 3 If applicable, please describe how non-governmental entities authorised/responsible for activities related to the designation and follow-up of notified bodies (i.e. private notifying authorities) are monitored . Please provide, for example, the annual number of planned and carried out verifications and/or coordination meetings with such private organi s ations . Click here to enter text. Question STYLEREF 1 \s 3 . SEQ Question_ \* ARABIC \s 1 4 Please provide the f requency ( A rt icle 18 ( 2) ) of the verifications for each NB ( i.e. number of verifications per year or biennium) . Click here to enter text. Question STYLEREF 1 \s 3 . SEQ Question_ \* ARABIC \s 1 5 Please provide the total number of verifications of NBs carried out in the last 3 years by your notifying authority ( A rt icle 18 ( 1 ) ) and/or national accreditation bodies ( A rt icle 18 ( 3 ) ) and/or delegated non-governmental entities ( A rt icle 18 ( 4 ) ) . Please provide also the number of laboratory/test site verifications . Total number of verifications of NBs according to EN ISO/IEC 17065:2012 Number of laboratories/test site verifications according to EN ISO/IEC 17025:2005 . Click here to enter text. Click here to enter text. Question STYLEREF 1 \s 3 . SEQ Question_ \* ARABIC \s 1 6 Please provide the number of audit reports, as carried out by your competent authority, to appoint/follow-up your NBs within the last 3 years . Click here to enter text. Question STYLEREF 1 \s 3 . SEQ Question_ \* ARABIC \s 1 7 Please provide the number (if any) of assessment bodies based in your MS not meeting the requirements of standard EN ISO/IEC 17065:2012 in the last 3 years . Click here to enter text. Question STYLEREF 1 \s 3 . SEQ Question_ \* ARABIC \s 1 8 Please provide the number (if any) of testing laboratories used for conformity assessment purposes not meeting the requirements of standard EN ISO/IEC 17025:2005 in the last 3 years . Click here to enter text. Question STYLEREF 1 \s 3 . SEQ Question_ \* ARABIC \s 1 9 Please provide the number of conformity assessment procedures in the last 3 years by NBs based in your MS with recourse to subcontractors or subsidiaries for specific tasks ( A rt icle 20 ( 1 ) ) . Click here to enter text. Question STYLEREF 1 \s 3 . SEQ Question_ \* ARABIC \s 1 10 Please provide the number of verifications (in the last 3 years) by your notifying authority of the qualifications and/or of the work carried out by such subcontractors or subsidiaries . ( A rt icle 20 ( 4 )). Click here to enter text. Question STYLEREF 1 \s 3 . SEQ Question_ \* ARABIC \s 1 11 Please provide the number of refusals, restrictions, suspensions or withdrawals of NBs’ notifications in the last 3 years, for both initial requests or during the monitoring phase/process . Please provide also the names of the NB concerned and the reasons . Total Number Names of concerned NBs Reason Refusals Click here to enter text. Click here to enter text. Click here to enter text. R estrictions or temporary suspensions Click here to enter text. Click here to enter text. Click here to enter text. Withdrawals Click here to enter text. Click here to enter text. Click here to enter text. Question STYLEREF 1 \s 3 . SEQ Question_ \* ARABIC \s 1 12 Please provide the number (if any) and the names of NBs (based in your MS) ceasing their activities in the last 3 years . Click here to enter text. Question STYLEREF 1 \s 3 . SEQ Question_ \* ARABIC \s 1 13 Please provide the number of requests by the Commission of corrective measures related to NBs no longer meeting the requirements for their notification ( A rt icle 22 ( 4 ) ) . Click here to enter text. Question STYLEREF 1 \s 3 . SEQ Question_ \* ARABIC \s 1 14 Please indicate the number of disagreements (if any) between different NBs concerning mutual recognition of conformity assessments and/or declarations of conformity (released by a NB based in your Member State ) . Click here to enter text. Question STYLEREF 1 \s 3 . SEQ Question_ \* ARABIC \s 1 15 Please provide the number of conformity assessment procedures carried out by each NB based in your Member State and the related number of issued (and valid) certificates . The MarED database (last access on the 22/05/2018) reports 4 valid certificates (issued by the European Agency of Inspecting and Certification OÜ). Please confirm or update such figures and provide further information in relation to the question above. Click here to enter text. Question STYLEREF 1 \s 3 . SEQ Question_ \* ARABIC \s 1 16 Please provide the number of quality systems (i.e. module D and E) approved, refused, suspended or otherwise restricted per NB. Please report also the number of planned and unannounced monitoring inspections (by NBs based in your country) for the above certified quality systems . Click here to enter text. Question STYLEREF 1 \s 3 . SEQ Question_ \* ARABIC \s 1 17 What is the frequency at which your Member State updates the NANDO and MarED databases ? Click here to enter text. Question STYLEREF 1 \s 3 . SEQ Question_ \* ARABIC \s 1 18 Please provide the number of measures/actions (e.g. inspections or restrictions for a product) taken following the suspension/withdrawn of a conformity certificate by NBs of another Member State (e.g. number of times a measure/action followed the suspension/withdrawn of a conformity certificate reported in MarED ) . Click here to enter text. Question STYLEREF 1 \s 3 . SEQ Question_ \* ARABIC \s 1 19 Please provide the number of Approved Draft Recommendations proposed by your NBs . Click here to enter text. Question STYLEREF 1 \s 3 . SEQ Question_ \* ARABIC \s 1 20 Please provide the number of messages/meetings or follow-up actions addressed to NBs, setting up national coordination groups in case not all NBs attend MarED . Please describe, if any, mirror groups or similar coordination measures/actions set for NBs’ coordination . Click here to enter text. Question STYLEREF 1 \s 3 . SEQ Question_ \* ARABIC \s 1 21 Please confirm, update and/or amend as necessary the number (and the percentage on the total) of MarED meetings attended by NBs of your Member State. European Agency of Inspecting and Certification OÜ: 1 meeting attended out of 2 (from 09/02/2017 until 24/11/2017) Click here to enter text. Market surveillance and follow-up actions Question STYLEREF 1 \s 4 . SEQ Question_ \* ARABIC \s 1 1 Please describe how market surveillance activities related to the MED are carried out . Click here to enter text. Is your Market Surveillance programme reactive and/or pro-active? Click here to enter text. Does it include both land based and on-board inspections? Click here to enter text. If on-board inspections are carried out, do they coincide/overlap with the inspections carried out for the flag State activities or are they planned/executed by different staff/administration? Click here to enter text. How often, during the market surveillance verification, laboratory tests are performed in addition to documentary checks? Click here to enter text. Question STYLEREF 1 \s 4 . SEQ Question_ \* ARABIC \s 1 2 If applicable, please describe how non-governmental entities authorised/responsible for market surveillance activities related to the MED are monitored . Please provide, for example, the annual number of verifications planned and carried out and/or coordination meetin gs with such third-party organis ations . Click here to enter text. Question STYLEREF 1 \s 4 . SEQ Question_ \* ARABIC \s 1 3 Please provide the number of conformity certificates granted to applicants based in your country (and still valid) . The MarED database (last access on the 22/05/2018) reports 20 valid certificates Click here to enter text. Question STYLEREF 1 \s 4 . SEQ Question_ \* ARABIC \s 1 4 Please provide the number of national importers and distributors . Click here to enter text. Question STYLEREF 1 \s 4 . SEQ Question_ \* ARABIC \s 1 5 How many MED items have been subject to surveillance campaigns in recent years? Please provide, for example, the n umber of market surveillance activities /verifications per year, differentiated by manufacturers’ and/or on-board inspections; please include/indicate only the on-board verifications not already included in the flag State activities. 2015 2016 2017 Number of market surveillance activities/verifications following a pro-active approach at manufacturers’ premises Click here to enter text. Click here to enter text. Click here to enter text. Number of market surveillance activities/verifications following a reactive approach at manufacturers’ premises Click here to enter text. Click here to enter text. Click here to enter text. Number of on-board market surveillance activities/verifications following a pro-active approach Click here to enter text. Click here to enter text. Click here to enter text. Number of on-board market surveillance activities/verifications following a reactive approach Click here to enter text. Click here to enter text. Click here to enter text. Question STYLEREF 1 \s 4 . SEQ Question_ \* ARABIC \s 1 6 How many market surveillance joint programmes/verifications (carried out by several Member States ) in which you have participated? Click here to enter text. Question STYLEREF 1 \s 4 . SEQ Question_ \* ARABIC \s 1 7 If applicable, please provide the number of cooperation/agreements with national authorities (e.g. consumers’ rights protection, counterfeiting/intellectual property protection, market and/or transport regulation author ities, Customs, etc.) or market surveillance administrations of other MSs . If any, please also briefly describe/detail them. Click here to enter text. Question STYLEREF 1 \s 4 . SEQ Question_ \* ARABIC \s 1 8 If applicable, please provide the annual budget/cost of cooperation/agreements with national authorities or market surveillance administrations of other Member States. Click here to enter text. Question STYLEREF 1 \s 4 . SEQ Question_ \* ARABIC \s 1 9 Have you ever requested directly (or participated in any joint project to get) funds from the European Commission for market surveillance activities, as indicated/suggested in the EC Regulation 765/2008? If so, please describe the project and provide the amount of the funds received. Click here to enter text. Question STYLEREF 1 \s 4 . SEQ Question_ \* ARABIC \s 1 10 Please describe any risk-based target mechanism used to select items/equipment to be subject to a surveillance campaign (i.e. use of statistics on risk/failure probability for the different MED items, accidents data, RAPEX/ MarED information, conformity modules/procedures required, size of the specific market in your country, etc.) . Click here to enter text. Question STYLEREF 1 \s 4 . SEQ Question_ \* ARABIC \s 1 11 Please provide the following information related to market surveillance verifications . 2015 2016 2017 Total number of market surveillance verifications Click here to enter text. Click here to enter text. Click here to enter text. Number of documentary checks (product documentation) Click here to enter text. Click here to enter text. Click here to enter text. Number of sample checks (testing) Click here to enter text. Click here to enter text. Click here to enter text. Number of samples sent to laboratories Click here to enter text. Click here to enter text. Click here to enter text. Total number of non-compliances raised by market surveillance verifications Click here to enter text. Click here to enter text. Click here to enter text. Number of identified fraudulent/counterfeit items Click here to enter text. Click here to enter text. Click here to enter text. Question STYLEREF 1 \s 4 . SEQ Question_ \* ARABIC \s 1 12 Please indicate if laboratories for tests related to market surveillance activities are private and/or State-owned . Click here to enter text. Question STYLEREF 1 \s 4 . SEQ Question_ \* ARABIC \s 1 13 Please provide the total annual budget/cost for laboratories’ tests in relation to market surveillance activities . Click here to enter text. Question STYLEREF 1 \s 4 . SEQ Question_ \* ARABIC \s 1 14 Please provide the annual cost/budget (if any) for scanning technologies in relation to electronic tags . Click here to enter text. Question STYLEREF 1 \s 4 . SEQ Question_ \* ARABIC \s 1 15 Please describe difficulties (if any) related to the identification or communication with authorised representative of manufacturers’ based outside EU (e.g. products sold on-line) . Click here to enter text. Question STYLEREF 1 \s 4 . SEQ Question_ \* ARABIC \s 1 16 How many verifications of marine equipment of which the manufacturers are based outside the EU have been carried out and what was the average response time of these manufacturers to your requests? Click here to enter text. Question STYLEREF 1 \s 4 . SEQ Question_ \* ARABIC \s 1 17 Please describe how the risks of identified non-compliances are analysed/quantified . Click here to enter text. How are the hazards defined and the appropriate corrective actions selected? Click here to enter text. Are corrective actions based on an appropriate risk-analysis (e.g. based on gravity/danger of the non-compliances, size of the impacted ‘population/environment’, possible overall impacts/effects on users/environment, etc.)? Click here to enter text. Question STYLEREF 1 \s 4 . SEQ Question_ \* ARABIC \s 1 18 Please provide the following information related to actions/measures requested by your competent authority to the economic operators (manufacturers, importers, distributors, etc.) following an identified non-compliance of marine equipment . 2015 2016 2017 Number of requested corrective actions Click here to enter text. Click here to enter text. Click here to enter text. Number of follow-up/monitoring verifications by the competent authority that the required corrective measures are properly taken Click here to enter text. Click here to enter text. Click here to enter text. Number (if any) of non-satisfactory corrective actions/measures taken by the manufacturers Click here to enter text. Click here to enter text. Click here to enter text. Number of forced withdrawals Click here to enter text. Click here to enter text. Click here to enter text. Number of ordered temporary recalls Click here to enter text. Click here to enter text. Click here to enter text. Question STYLEREF 1 \s 4 . SEQ Question_ \* ARABIC \s 1 19 Please describe the penalty system/regime (according to A rt icle 41 of Regulation EC 765/2008) for manufacturers not properly replying/cooperating or not applying properly the defined corrective actions/measures. Click here to enter text. Question STYLEREF 1 \s 4 . SEQ Question_ \* ARABIC \s 1 20 If applicable, please provide the number and the amount of the penalties imposed following market surveillance activities (e.g. for manufacturers not properly replying/cooperating or not properly applying the defined corrective actions/measures) . 2015 2016 2017 Number of penalties issued Click here to enter text. Click here to enter text. Click here to enter text. Total amount of penalties imposed Click here to enter text. Click here to enter text. Click here to enter text. Question STYLEREF 1 \s 4 . SEQ Question_ \* ARABIC \s 1 21 Please provide the number of cases (if any) in which marine equipment was compliant with the MED but nevertheless presented a risk to maritime safety, to health or to the environment ( A rt icle 28 of the MED ) . Please also provide a brief description of such cases . Click here to enter text. Question STYLEREF 1 \s 4 . SEQ Question_ \* ARABIC \s 1 22 Please provide the following data related to safety concerns shared with other Member States through ICSMS and alerts inserted in RAPEX by your competent authority, and/or safety concerns raised by non-governmental third-party stakeholders . 2015 2016 2017 Please provide the number of safety concerns shared with other MSs through ICSMS by your competent authority . Click here to enter text. Click here to enter text. Click here to enter text. Out of the above safety concerns, how many are followed by an action of your competent authority? Click here to enter text. Click here to enter text. Click here to enter text. Please provide the number of alerts inserted in RAPEX by your competent authority . Click here to enter text. Click here to enter text. Click here to enter text. Out of the above RAPEX alerts, how many are followed by an action of your competent authority? Click here to enter text. Click here to enter text. Click here to enter text. Please provide the number of safety concerns raised by non-governmental third-party stakeholders (e.g. industry competitors, shipmasters, etc.) . Click here to enter text. Click here to enter text. Click here to enter text. Out of the above safety concerns, how many are followed by an action of your competent authority? Click here to enter text. Click here to enter text. Click here to enter text. Question STYLEREF 1 \s 4 . SEQ Question_ \* ARABIC \s 1 23 Please describe how your market surveillance authorities ensure/organi s e regular and proper communications with the Commission , other Member States , NBs, and involved manufacturers regarding market surveillance activities and/or related findings (e.g. through the use of the EC information/database systems, through an active participation in the ADCO MED meetings, etc.) . Click here to enter text. Question STYLEREF 1 \s 4 . SEQ Question_ \* ARABIC \s 1 24 Please provide the number of reports/communications from the market surveillance authority to the Commission, to other Member States and to NBs . Click here to enter text. Question STYLEREF 1 \s 4 . SEQ Question_ \* ARABIC \s 1 25 Please provide (if any) the number of objections by other Member States or the Commission concerning the measures taken by your market surveillance authority ( A rt icle 26 ( 7 ) ) . Click here to enter text. Question STYLEREF 1 \s 4 . SEQ Question_ \* ARABIC \s 1 26 Please provide the number of times (if any), in which it was necessary to apply the safeguard clause (EC interventions) in relation to measures taken by your market surveillance authority . Click here to enter text. Question STYLEREF 1 \s 4 . SEQ Question_ \* ARABIC \s 1 27 Please provide the number (if any) of Commission Decisions for withdrawal and/or acceptance of the measures taken by your market surveillance authority following the application of the safeguard clause . Click here to enter text. EU-MS cooperation and mutual assistance Question STYLEREF 1 \s 5 . SEQ Question_ \* ARABIC \s 1 1 Please describe how do you organi s e the participation of your competent authorities in Standardi s ation activities, in the ADCO group, in the MED Expert Group and in the COSS (Committee on Safe Seas) meetings . Click here to enter text. Question STYLEREF 1 \s 5 . SEQ Question_ \* ARABIC \s 1 2 Please provide the number and the percentage of meetings attended by your competent authority staff in the last 3 years (2015-2017) concerning: Number of attended meetings Percentage (on the total) of attended meetings Standardi s ation activities Click here to enter text. Click here to enter text. ADCO group meetings (market surveillance) Click here to enter text. Click here to enter text. MED Expert group meetings (implementing regulations and delegating acts) Click here to enter text. Click here to enter text. Mar-ED group meetings 0 out of 3 Click here to enter text. 0% Click here to enter text. COSS meetings Click here to enter text. Click here to enter text. Other cooperation and mutual assistance activities Click here to enter text. Click here to enter text. Open Questions Question STYLEREF 1 \s 6 . SEQ Question_ \* ARABIC \s 1 1 Did you experience difficulties, challenges and needs when implementing some of the requirements of the Directive or when enforcing them ? If so, please provide feedback on these difficulties, challenges and needs for each of the identified processes or articles concerned . In the pre-cycle workshop the following possible difficulties/challenges were identified in relation to the process ‘Designation and follow-up of Notified Bodies’: Lack of accreditation service for that specific activity. Lack of tools to supervise notified bodies’ activities. Please provide any further information you deem useful. Click here to enter text. Question STYLEREF 1 \s 6 . SEQ Question_ \* ARABIC \s 1 2 In your opinion, what are the main benefits of the implementation and enforcement of the Directive ( such as in comparison with the measures and the situation in place before that such legislation came into force)? Click here to enter text. Question STYLEREF 1 \s 6 . SEQ Question_ \* ARABIC \s 1 3 In your opinion, what measures or proposals could be implemented in order to improve the efficiency (relation between costs and effects) of the measures put in place to comply with the Directive? Click here to enter text. Ref. Ares(2018)2987492 - 07/06/2018 Doc. No. QCEA.1.00 Version: 1.0 Issue date: 07/06/2018 Unit B.1 Visits & Inspections Page: 1 of 18 QUESTIONNAIRE FOR THE COST-EFFECTIVENESS ANALYSIS RELATING TO DIRECTIVE Title: 2014/90/EU ON MARINE EQUIPMENT QUESTIONNAIRE FOR THE COST-EFFECTIVENESS ANALYSIS OF MEMBER STATES’ MEASURES TO IMPLEMENT THE MARINE EQUIPMENT DIRECTIVE Directive 2014/90/EU of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC Click to select  Doc. No. QCEA.1.00 Version: 1.0 Issue date: 07/06/2018 Unit B.1 Visits & Inspections Page: 2 of 18 QUESTIONNAIRE FOR THE COST-EFFECTIVENESS ANALYSIS RELATING TO DIRECTIVE Title: 2014/90/EU ON MARINE EQUIPMENT INTRODUCTION Article 3.5 of the EMSA founding regulation provides that “where appropriate, and in any case when a cycle of visits or inspections is concluded, the Agency shall analyse reports from that cycle with a view to identifying horizontal findings and general conclusions on the effectiveness and cost-efficiency of the measures in place. The Agency shall present this analysis to the Commission for further discussion with Member States in order to draw any relevant lessons and facilitate the dissemination of good working practices.” Moreover, the new Methodology for Visits to Member States adopted by the EMSA Administrative Board in November 2015 states that “the horizontal findings arising from the cycles of visits to the Member States will serve to analyse areas of common concern in implementation, as well as identify best practices and lessons learnt on the effectiveness and cost efficiency of the measures in place”. As a consequence, EMSA has developed a cost-efficiency assessment methodology for this type of analysis. The Administrative Board agreed that this approach should be applied to future visit cycles relating to the implementation of Union Law in November 2016. This exercise will provide an overall comparative analysis of the costs incurred by Member States when complying with the requirements of the Marine Equipment Directive (MED) as part of the overall relevant cost- efficiency assessment. It is not intended to verify regulatory compliance. In order to carry out this exercise, EMSA has carried out a preliminary data collection and pre-assessment analysis of the information available from previous EMSA visits, from relevant databases (e.g. RAPEX, ICSMS, MarED, NANDO, etc.) and from the pre-cycle questionnaire sent to each Member State in April 2017, so as to minimise the request for information. The replies to this questionnaire will be used to confirm and complement the information already available for the cost-effectiveness analysis. Some of the questions require only confirmation of the data provided during the EMSA visits and the pre-cycle workshop or collected from relevant databases. Other questions require additional information. Finally, open questions have been included as an opportunity for you to convey your expert opinion with a view to gathering further valuable input for the purpose of this exercise. This questionnaire mirrors a process analysis approach under which the standard methodology for carrying out the visits has been developed. Each process involves a compilation of related requirements laid down in the Directive (see Figure 1). These processes organise the requirements by main areas of activity. The following processes have been identified for this cycle of visits in respect of the Directive: − Flag State activities: This process includes all the operational MED activities and duties that a Member State has to carry out in its capacity as flag State. These activities include: ensuring that the marine equipment on board the flag State’s ships complies with the requirements of the MED or alternatively, in the case of a non-EU ship transferring in, is equivalent to the MED standards; not prohibiting the placing on board of marine equipment which complies with the MED; and issuing exemptions under the circumstances defined in the MED. − Designation and follow-up of Notified Bodies: This process considers all activities regulated by the articles of the Directive that refer to Notified Bodies (NBs) and that are carried out by the Notifying Authority (be it a specifically designated authority, the National Accreditation Body or another authorised non- governmental entity). These actions range from the authorisation of NBs to their monitoring and assessment, including all the actions undertaken to notify the Commission of new notifications or changes to existing ones. − Market Surveillance and follow-up action: This process comprises all articles of the Directive governing the activities of national market surveillance of marine equipment. These activities comprise the designation of market surveillance authorities and related infrastructures, drawing up market surveillance programmes that include checks on pieces of equipment (documentary, on board and sample checks), the identification  Doc. No. QCEA.1.00 Version: 1.0 Issue date: 07/06/2018 Unit B.1 Visits & Inspections Page: 3 of 18 QUESTIONNAIRE FOR THE COST-EFFECTIVENESS ANALYSIS RELATING TO DIRECTIVE Title: 2014/90/EU ON MARINE EQUIPMENT of specific equipment posing a potential hazard and all the related actions to communicate the outcome of these activities to interested parties. − EU-MS cooperation and mutual assistance: This process covers the requirements of the MED for organising all marine equipment standardisation and coordination activities among EU Member States and among NBs, including the exchange of practical experience and participation in specific sectoral working groups. Figure 1 - Process breakdown structure of the MED Directive (core application processes in blue; implementation preliminary processes in orange; activities in green)  Doc. No. QCEA.1.00 Version: 1.0 Issue date: 07/06/2018 Unit B.1 Visits & Inspections Page: 4 of 18 QUESTIONNAIRE FOR THE COST-EFFECTIVENESS ANALYSIS RELATING TO DIRECTIVE Title: 2014/90/EU ON MARINE EQUIPMENT QUESTIONNAIRE 1. Human and financial resources/costs Question 1.1 Having regard to the information reported in the pre-cycle workshop questionnaire sent to your Member State in April 2017, please confirm, amend or provide as necessary the number of full time equivalent staff members on an annual basis who are directly involved in the following processes related to the MED. If the processes’ activities are partly or fully delegated to non-governmental entities, please indicate your best estimate of the number of staff concerned. Definitions: Where the activities (e.g. inspections) carried out in the context of the MED represent only part of the work carried out by the staff involved, the staff must be converted to a number of full-time equivalent officers. Full time equivalents are used to describe the involvement of each staff member in MED activities, for example: A full time officer with 100% of the working time related to MED activities = 1 Full time officer. A part time officer with 20% of the working time related to MED activities= 0.2 Full time officer. For those Member States where MED related activities are carried out within other legislative frameworks (e.g. flag State or port State control activities), this figure should reflect only the working time dedicated to the specific activities which are relevant to the MED. PROCESS No. Full Time No. Part Time Annual Full (100% duties (Indicate % of the Time Equivalent related to the activity related to MED) the MED) Flag State governmental entity Click here to Click here to enter Click here to activities enter text. text. enter text. non-governmental Click here to Click here to enter Click here to entity (e.g. ROs) enter text. text. enter text. Designation governmental entity Click here to Click here to enter Click here to and follow- enter text. text. enter text. up of Notified non-governmental Click here to Click here to enter Click here to Bodies entity enter text. text. enter text. Market governmental entity Click here to Click here to enter Click here to Surveillance enter text. text. enter text. non-governmental Click here to Click here to enter Click here to entity enter text. text. enter text. EU-MS governmental entity Click here to Click here to enter Click here to cooperation enter text. text. enter text. and mutual assistance  Doc. No. QCEA.1.00 Version: 1.0 Issue date: 07/06/2018 Unit B.1 Visits & Inspections Page: 5 of 18 QUESTIONNAIRE FOR THE COST-EFFECTIVENESS ANALYSIS RELATING TO DIRECTIVE Title: 2014/90/EU ON MARINE EQUIPMENT Question 1.2 Please provide the total annual budget (including administrative and travel costs, planning, etc.) for all the activities concerning the processes related to the MED. If the processes’ activities are partly or fully delegated to non-governmental entities through public funded contracts, please indicate their values. PROCESS Total annual budget (in €) Annual value of public-funded contracts Flag State activities Click here to enter text. Click here to enter text. Designation and follow-up of Click here to enter text. Click here to enter text. Notified Bodies Market Surveillance Click here to enter text. Click here to enter text. EU-MS cooperation and mutual Click here to enter text. Click here to enter text. assistance Question 1.3 Please indicate the most expensive specific activities within the above processes. Click here to enter text. Question 1.4 Please provide (if any) additional/extra costs (not mentioned in this questionnaire) which may have an impact on the budgets/expenses related to the implementation of the MED (e.g. adjustment and/or new IT systems, etc.). Click here to enter text. Question 1.5 Please provide the annual person-hours for the following MED key activities/tasks requested to MSs by the Directive. Please differentiate between the person-hours involving staff of public or private entities. Annual person-hours for: Public administrations Non-governmental (private) entities On-board verifications Click here to enter text. Click here to enter text. Desktop analysis (e.g. office-based Click here to enter text. Click here to enter text. documents verification, design verification, etc.) Monitoring and auditing NBs Click here to enter text. Click here to enter text. Performing checks Documentary Click here to enter text. Click here to enter text. on equipment verifications On board checks Click here to enter text. Click here to enter text. Question 1.6 Please provide the average number of annual training hours per person for staff involved in MED related activities. Training provided and/or Click here to enter text. attended in EMSA Training provided by the Click here to enter text. national authorities  Doc. No. QCEA.1.00 Version: 1.0 Issue date: 07/06/2018 Unit B.1 Visits & Inspections Page: 6 of 18 QUESTIONNAIRE FOR THE COST-EFFECTIVENESS ANALYSIS RELATING TO DIRECTIVE Title: 2014/90/EU ON MARINE EQUIPMENT 2. FLAG STATE ACTIVITIES Question 2.1 Please provide the annual number of verifications related to the MED carried out on- board vessels flying your Flag. 2015 2016 2017 Announced verifications Click here to enter Click here to enter Click here to enter text. text. text. Unannounced verifications Click here to enter Click here to enter Click here to enter text. text. text. Question 2.2 How do you select/target the vessels flying your Flag to be subjected to on-board surveys? Click here to enter text. Question 2.3 If applicable, do you authorise ROs for MED activities/surveys and, if so, do you include specific references to MED activities in your agreements with these ROs? Click here to enter text. Question 2.4 Please provide the number of vessels flying your Flag under the scope of the MED (differentiated between vessels surveyed and certified by governmental or non- governmental entities). 2015 2016 2017 Surveyed and certified by Click here to enter Click here to enter Click here to enter governmental entities text. text. text. Surveyed and certified by Click here to enter Click here to enter Click here to enter non-governmental entities text. text. text. Total Click here to enter Click here to enter Click here to enter text. text. text. Question 2.5 If applicable, please describe how non-governmental entities (e.g. ROs, etc.) authorised/responsible for MED related flag State activities are monitored. Please provide, for example, the annual number of verifications planned and carried out and/or coordination meetings with such private organisations. Click here to enter text. Question 2.6 Please indicate if and how do you extend the applicability of the Directive even to vessels flying your Flag but not falling within the scope of the Directive. Click here to enter text.  Doc. No. QCEA.1.00 Version: 1.0 Issue date: 07/06/2018 Unit B.1 Visits & Inspections Page: 7 of 18 QUESTIONNAIRE FOR THE COST-EFFECTIVENESS ANALYSIS RELATING TO DIRECTIVE Title: 2014/90/EU ON MARINE EQUIPMENT Question 2.7 Please provide the following information on identified non-compliances related to MED equipment on-board vessels flying your Flag. 2015 2016 2017 Total annual number of Click here to enter Click here to enter Click here to enter non-compliances text. text. text. Non-compliances related to Click here to enter Click here to enter Click here to enter wheel-mark/documents text. text. text. Non-compliances related to Click here to enter Click here to enter Click here to enter procedures/type approval text. text. text. Operational non- Click here to enter Click here to enter Click here to enter compliances (wrong text. text. text. maintenance or use of the item) Product non-compliances Click here to enter Click here to enter Click here to enter text. text. text. Number of identified Click here to enter Click here to enter Click here to enter counterfeit products text. text. text. Question 2.8 Please confirm that the lists of items reported in RAPEX/ICSMS or the lists of the certificates withdrawn, cancelled or temporary suspended from MarED are regularly updated, promptly circulated and properly used during the MED related verifications. Please describe briefly the whole process. Click here to enter text. Question 2.9 Please provide the following information related to verifications of MED equipment. Please describe your targeting criteria (if Click here to enter text. any) to select the items to be subject to verification (e.g. based on a statistical approach). Are all the items of MED equipment verified Click here to enter text. at each survey? If not, is all the marine equipment fully verified at least once at any stage and then afterwards only items changed, modified and/or suspected are further surveyed? Question 2.10 Please provide the number of cases in the last 5 years (if any), in which a wheel-marked piece of equipment has been questioned by any MED stakeholder for being placed on board a ship (i.e. number of external complaints and/or warnings received). Click here to enter text.  Doc. No. QCEA.1.00 Version: 1.0 Issue date: 07/06/2018 Unit B.1 Visits & Inspections Page: 8 of 18 QUESTIONNAIRE FOR THE COST-EFFECTIVENESS ANALYSIS RELATING TO DIRECTIVE Title: 2014/90/EU ON MARINE EQUIPMENT Question 2.11 Please provide the following information related to vessels flying your Flag and transferred from a non-EU country. 2015 2016 2017 Number of non-EU vessels Click here to Click here to Click here to transferred to your Flag State enter text. enter text. enter text. Number of non-compliances of Click here to Click here to Click here to marine equipment on board of enter text. enter text. enter text. non-EU ships transferred to your Flag State Number (if any) of equivalence Click here to Click here to Click here to certificates issued for marine enter text. enter text. enter text. equipment on board of non-EU ships transferred to your Flag State Question 2.12 Please describe the difficulties encountered (if any) in transferring non-EU ships to your Flag (e.g. problems in verifying equipment and/or in issuing equivalence certificates, etc.). Please provide also the causes/reasons of such difficulties. Click here to enter text. Question 2.13 Please provide the number of requested and the number of granted exemptions for marine equipment on board vessels flying your flag in the last 3 years, classified by category (i.e. for technical innovation - Article 30, for testing or evaluation – Article 31, for exceptional circumstances – Article 32) Number of requested Number of granted exemptions exemptions For technical innovation Click here to enter text. Click here to enter text. For testing or evaluation Click here to enter text. Click here to enter text. For exceptional circumstances Click here to enter text. Click here to enter text. Question 2.14 Please provide the average response time to exemptions’ requests (if any), particularly from remote locations. Click here to enter text. Question 2.15 Please provide the average duration of approved exemptions (if any) for testing or evaluation (Article 31(b). Click here to enter text.  Doc. No. QCEA.1.00 Version: 1.0 Issue date: 07/06/2018 Unit B.1 Visits & Inspections Page: 9 of 18 QUESTIONNAIRE FOR THE COST-EFFECTIVENESS ANALYSIS RELATING TO DIRECTIVE Title: 2014/90/EU ON MARINE EQUIPMENT Question 2.16 Please provide the number in the last 3 years (if any) of issued interim certificates (Article 32(5)-(7)) following a demonstration that wheel-marked marine equipment was not available on the market. Please add any further detail you deem useful. Click here to enter text. Question 2.17 Please provide the number of requests (if any) by the Commission to withdraw permissions for exemptions granted to marine equipment on board vessels flying your Flag (Article 30(5) or 32(8)). Click here to enter text. 3. Designation and follow-up of Notified Bodies (NBs) Question 3.1 Please provide, confirm or amend as necessary the number of applications for becoming a NB and the related number of granted notifications. Number of applications Number of granted notifications Click here to enter text. Click here to enter text. Question 3.2 Please, for each approved NB, confirm or amend as necessary also its name and the number of modules covered by the granted notification. Click here to enter text. Question 3.3 If applicable, please describe how non-governmental entities authorised/responsible for activities related to the designation and follow-up of notified bodies (i.e. private notifying authorities) are monitored. Please provide, for example, the annual number of planned and carried out verifications and/or coordination meetings with such private organisations. Click here to enter text. Question 3.4 Please provide the frequency (Article 18(2)) of the verifications for each NB (i.e. number of verifications per year or biennium). Click here to enter text. Question 3.5 Please provide the total number of verifications of NBs carried out in the last 3 years by your notifying authority (Article 18(1)) and/or national accreditation bodies (Article 18(3)) and/or delegated non-governmental entities (Article 18(4)). Please provide also the number of laboratory/test site verifications. Total number of verifications of NBs Number of laboratories/test site verifications according to EN ISO/IEC 17065:2012 according to EN ISO/IEC 17025:2005. Click here to enter text. Click here to enter text. Question 3.6 Please provide the number of audit reports, as carried out by your competent authority, to appoint/follow-up your NBs within the last 3 years. Click here to enter text.  Doc. No. QCEA.1.00 Version: 1.0 Issue date: 07/06/2018 Unit B.1 Visits & Inspections Page: 10 of 18 QUESTIONNAIRE FOR THE COST-EFFECTIVENESS ANALYSIS RELATING TO DIRECTIVE Title: 2014/90/EU ON MARINE EQUIPMENT Question 3.7 Please provide the number (if any) of assessment bodies based in your MS not meeting the requirements of standard EN ISO/IEC 17065:2012 in the last 3 years. Click here to enter text. Question 3.8 Please provide the number (if any) of testing laboratories used for conformity assessment purposes not meeting the requirements of standard EN ISO/IEC 17025:2005 in the last 3 years. Click here to enter text. Question 3.9 Please provide the number of conformity assessment procedures in the last 3 years by NBs based in your MS with recourse to subcontractors or subsidiaries for specific tasks (Article 20(1)). Click here to enter text. Question 3.10 Please provide the number of verifications (in the last 3 years) by your notifying authority of the qualifications and/or of the work carried out by such subcontractors or subsidiaries. (Article 20(4)). Click here to enter text. Question 3.11 Please provide the number of refusals, restrictions, suspensions or withdrawals of NBs’ notifications in the last 3 years, for both initial requests or during the monitoring phase/process. Please provide also the names of the NB concerned and the reasons. Total Number Names of Reason concerned NBs Refusals Click here to enter Click here to enter Click here to enter text. text. text. Restrictions or Click here to enter Click here to enter Click here to enter temporary text. text. text. suspensions Withdrawals Click here to enter Click here to enter Click here to enter text. text. text. Question 3.12 Please provide the number (if any) and the names of NBs (based in your MS) ceasing their activities in the last 3 years. Click here to enter text. Question 3.13 Please provide the number of requests by the Commission of corrective measures related to NBs no longer meeting the requirements for their notification (Article 22(4)). Click here to enter text.  Doc. No. QCEA.1.00 Version: 1.0 Issue date: 07/06/2018 Unit B.1 Visits & Inspections Page: 11 of 18 QUESTIONNAIRE FOR THE COST-EFFECTIVENESS ANALYSIS RELATING TO DIRECTIVE Title: 2014/90/EU ON MARINE EQUIPMENT Question 3.14 Please indicate the number of disagreements (if any) between different NBs concerning mutual recognition of conformity assessments and/or declarations of conformity (released by a NB based in your Member State). Click here to enter text. Question 3.15 Please provide the number of conformity assessment procedures carried out by each NB based in your Member State and the related number of issued (and valid) certificates. Click here to enter text. Question 3.16 Please provide the number of quality systems (i.e. module D and E) approved, refused, suspended or otherwise restricted per NB. Please report also the number of planned and unannounced monitoring inspections (by NBs based in your country) for the above certified quality systems. Click here to enter text. Question 3.17 What is the frequency at which your Member State updates the NANDO and MarED databases? Click here to enter text. Question 3.18 Please provide the number of measures/actions (e.g. inspections or restrictions for a product) taken following the suspension/withdrawn of a conformity certificate by NBs of another Member State (e.g. number of times a measure/action followed the suspension/withdrawn of a conformity certificate reported in MarED). Click here to enter text. Question 3.19 Please provide the number of Approved Draft Recommendations proposed by your NBs. Click here to enter text. Question 3.20 Please provide the number of messages/meetings or follow-up actions addressed to NBs, setting up national coordination groups in case not all NBs attend MarED. Please describe, if any, mirror groups or similar coordination measures/actions set for NBs’ coordination. Click here to enter text. Question 3.21 Please confirm, update and/or amend as necessary the number (and the percentage on the total) of MarED meetings attended by NBs of your Member State. Click here to enter text.  Doc. No. QCEA.1.00 Version: 1.0 Issue date: 07/06/2018 Unit B.1 Visits & Inspections Page: 12 of 18 QUESTIONNAIRE FOR THE COST-EFFECTIVENESS ANALYSIS RELATING TO DIRECTIVE Title: 2014/90/EU ON MARINE EQUIPMENT 4. Market surveillance and follow-up actions Question 4.1 Please describe how market surveillance activities Click here to enter text. related to the MED are carried out. Is your Market Surveillance programme reactive and/or Click here to enter text. pro-active? Does it include both land based and on-board Click here to enter text. inspections? If on-board inspections are carried out, do they Click here to enter text. coincide/overlap with the inspections carried out for the flag State activities or are they planned/executed by different staff/administration? How often, during the market surveillance verification, Click here to enter text. laboratory tests are performed in addition to documentary checks? Question 4.2 If applicable, please describe how non-governmental entities authorised/responsible for market surveillance activities related to the MED are monitored. Please provide, for example, the annual number of verifications planned and carried out and/or coordination meetings with such third-party organisations. Click here to enter text. Question 4.3 Please provide the number of conformity certificates granted to applicants based in your country (and still valid). Click here to enter text. Question 4.4 Please provide the number of national importers and distributors. Click here to enter text. Question 4.5 How many MED items have been subject to surveillance campaigns in recent years? Please provide, for example, the number of market surveillance activities/verifications per year, differentiated by manufacturers’ and/or on-board inspections; please include/indicate only the on-board verifications not already included in the flag State activities. 2015 2016 2017 Number of market surveillance Click here to Click here to Click here to activities/verifications following a pro- enter text. enter text. enter text. active approach at manufacturers’ premises Number of market surveillance Click here to Click here to Click here to activities/verifications following a enter text. enter text. enter text. reactive approach at manufacturers’ premises  Doc. No. QCEA.1.00 Version: 1.0 Issue date: 07/06/2018 Unit B.1 Visits & Inspections Page: 13 of 18 QUESTIONNAIRE FOR THE COST-EFFECTIVENESS ANALYSIS RELATING TO DIRECTIVE Title: 2014/90/EU ON MARINE EQUIPMENT Number of on-board market Click here to Click here to Click here to surveillance activities/verifications enter text. enter text. enter text. following a pro-active approach Number of on-board market Click here to Click here to Click here to surveillance activities/verifications enter text. enter text. enter text. following a reactive approach Question 4.6 How many market surveillance joint programmes/verifications (carried out by several Member States) in which you have participated? Click here to enter text. Question 4.7 If applicable, please provide the number of cooperation/agreements with national authorities (e.g. consumers’ rights protection, counterfeiting/intellectual property protection, market and/or transport regulation authorities, Customs, etc.) or market surveillance administrations of other MSs. If any, please also briefly describe/detail them. Click here to enter text. Question 4.8 If applicable, please provide the annual budget/cost of cooperation/agreements with national authorities or market surveillance administrations of other Member States. Click here to enter text. Question 4.9 Have you ever requested directly (or participated in any joint project to get) funds from the European Commission for market surveillance activities, as indicated/suggested in the EC Regulation 765/2008? If so, please describe the project and provide the amount of the funds received. Click here to enter text. Question 4.10 Please describe any risk-based target mechanism used to select items/equipment to be subject to a surveillance campaign (i.e. use of statistics on risk/failure probability for the different MED items, accidents data, RAPEX/MarED information, conformity modules/procedures required, size of the specific market in your country, etc.). Click here to enter text. Question 4.11 Please provide the following information related to market surveillance verifications. 2015 2016 2017 Total number of market Click here to enter Click here to enter Click here to enter surveillance verifications text. text. text. Number of documentary Click here to enter Click here to enter Click here to enter checks (product text. text. text. documentation) Number of sample checks Click here to enter Click here to enter Click here to enter (testing) text. text. text.  Doc. No. QCEA.1.00 Version: 1.0 Issue date: 07/06/2018 Unit B.1 Visits & Inspections Page: 14 of 18 QUESTIONNAIRE FOR THE COST-EFFECTIVENESS ANALYSIS RELATING TO DIRECTIVE Title: 2014/90/EU ON MARINE EQUIPMENT Number of samples sent to Click here to enter Click here to enter Click here to enter laboratories text. text. text. Total number of non- Click here to enter Click here to enter Click here to enter compliances raised by text. text. text. market surveillance verifications Number of identified Click here to enter Click here to enter Click here to enter fraudulent/counterfeit items text. text. text. Question 4.12 Please indicate if laboratories for tests related to market surveillance activities are private and/or State-owned. Click here to enter text. Question 4.13 Please provide the total annual budget/cost for laboratories’ tests in relation to market surveillance activities. Click here to enter text. Question 4.14 Please provide the annual cost/budget (if any) for scanning technologies in relation to electronic tags. Click here to enter text. Question 4.15 Please describe difficulties (if any) related to the identification or communication with authorised representative of manufacturers’ based outside EU (e.g. products sold on-line). Click here to enter text. Question 4.16 How many verifications of marine equipment of which the manufacturers are based outside the EU have been carried out and what was the average response time of these manufacturers to your requests? Click here to enter text. Question 4.17 Please describe how the risks of identified non- Click here to enter text. compliances are analysed/quantified. How are the hazards defined and the appropriate Click here to enter text. corrective actions selected? Are corrective actions based on an appropriate risk- Click here to enter text. analysis (e.g. based on gravity/danger of the non- compliances, size of the impacted ‘population/environment’, possible overall impacts/effects on users/environment, etc.)?  Doc. No. QCEA.1.00 Version: 1.0 Issue date: 07/06/2018 Unit B.1 Visits & Inspections Page: 15 of 18 QUESTIONNAIRE FOR THE COST-EFFECTIVENESS ANALYSIS RELATING TO DIRECTIVE Title: 2014/90/EU ON MARINE EQUIPMENT Question 4.18 Please provide the following information related to actions/measures requested by your competent authority to the economic operators (manufacturers, importers, distributors, etc.) following an identified non-compliance of marine equipment. 2015 2016 2017 Number of requested corrective Click here to Click here to Click here to actions enter text. enter text. enter text. Number of follow-up/monitoring Click here to Click here to Click here to verifications by the competent enter text. enter text. enter text. authority that the required corrective measures are properly taken Number (if any) of non-satisfactory Click here to Click here to Click here to corrective actions/measures taken by enter text. enter text. enter text. the manufacturers Number of forced withdrawals Click here to Click here to Click here to enter text. enter text. enter text. Number of ordered temporary recalls Click here to Click here to Click here to enter text. enter text. enter text. Question 4.19 Please describe the penalty system/regime (according to Article 41 of Regulation EC 765/2008) for manufacturers not properly replying/cooperating or not applying properly the defined corrective actions/measures. Click here to enter text. Question 4.20 If applicable, please provide the number and the amount of the penalties imposed following market surveillance activities (e.g. for manufacturers not properly replying/cooperating or not properly applying the defined corrective actions/measures). 2015 2016 2017 Number of penalties Click here to enter Click here to enter Click here to enter issued text. text. text. Total amount of Click here to enter Click here to enter Click here to enter penalties imposed text. text. text. Question 4.21 Please provide the number of cases (if any) in which marine equipment was compliant with the MED but nevertheless presented a risk to maritime safety, to health or to the environment (Article 28 of the MED). Please also provide a brief description of such cases. Click here to enter text.  Doc. No. QCEA.1.00 Version: 1.0 Issue date: 07/06/2018 Unit B.1 Visits & Inspections Page: 16 of 18 QUESTIONNAIRE FOR THE COST-EFFECTIVENESS ANALYSIS RELATING TO DIRECTIVE Title: 2014/90/EU ON MARINE EQUIPMENT Question 4.22 Please provide the following data related to safety concerns shared with other Member States through ICSMS and alerts inserted in RAPEX by your competent authority, and/or safety concerns raised by non-governmental third-party stakeholders. 2015 2016 2017 Please provide the number of safety Click here to Click here to Click here to concerns shared with other MSs enter text. enter text. enter text. through ICSMS by your competent authority. Out of the above safety concerns, how Click here to Click here to Click here to many are followed by an action of your enter text. enter text. enter text. competent authority? Please provide the number of alerts Click here to Click here to Click here to inserted in RAPEX by your competent enter text. enter text. enter text. authority. Out of the above RAPEX alerts, how Click here to Click here to Click here to many are followed by an action of your enter text. enter text. enter text. competent authority? Please provide the number of safety Click here to Click here to Click here to concerns raised by non-governmental enter text. enter text. enter text. third-party stakeholders (e.g. industry competitors, shipmasters, etc.). Out of the above safety concerns, how Click here to Click here to Click here to many are followed by an action of your enter text. enter text. enter text. competent authority? Question 4.23 Please describe how your market surveillance authorities ensure/organise regular and proper communications with the Commission, other Member States, NBs, and involved manufacturers regarding market surveillance activities and/or related findings (e.g. through the use of the EC information/database systems, through an active participation in the ADCO MED meetings, etc.). Click here to enter text. Question 4.24 Please provide the number of reports/communications from the market surveillance authority to the Commission, to other Member States and to NBs. Click here to enter text. Question 4.25 Please provide (if any) the number of objections by other Member States or the Commission concerning the measures taken by your market surveillance authority (Article 26(7)). Click here to enter text.  Doc. No. QCEA.1.00 Version: 1.0 Issue date: 07/06/2018 Unit B.1 Visits & Inspections Page: 17 of 18 QUESTIONNAIRE FOR THE COST-EFFECTIVENESS ANALYSIS RELATING TO DIRECTIVE Title: 2014/90/EU ON MARINE EQUIPMENT Question 4.26 Please provide the number of times (if any), in which it was necessary to apply the safeguard clause (EC interventions) in relation to measures taken by your market surveillance authority. Click here to enter text. Question 4.27 Please provide the number (if any) of Commission Decisions for withdrawal and/or acceptance of the measures taken by your market surveillance authority following the application of the safeguard clause. Click here to enter text. 5. EU-MS cooperation and mutual assistance Question 5.1 Please describe how do you organise the participation of your competent authorities in Standardisation activities, in the ADCO group, in the MED Expert Group and in the COSS (Committee on Safe Seas) meetings. Click here to enter text. Question 5.2 Please provide the number and the percentage of meetings attended by your competent authority staff in the last 3 years (2015-2017) concerning: Number of attended Percentage (on the total) of meetings attended meetings Standardisation activities Click here to enter text. Click here to enter text. ADCO group meetings Click here to enter text. Click here to enter text. (market surveillance) MED Expert group meetings Click here to enter text. Click here to enter text. (implementing regulations and delegating acts) Mar-ED group meetings Click here to enter text. Click here to enter text. COSS meetings Click here to enter text. Click here to enter text. Other cooperation and Click here to enter text. Click here to enter text. mutual assistance activities  Doc. No. QCEA.1.00 Version: 1.0 Issue date: 07/06/2018 Unit B.1 Visits & Inspections Page: 18 of 18 QUESTIONNAIRE FOR THE COST-EFFECTIVENESS ANALYSIS RELATING TO DIRECTIVE Title: 2014/90/EU ON MARINE EQUIPMENT 6. Open Questions Question 6.1 Did you experience difficulties, challenges and needs when implementing some of the requirements of the Directive or when enforcing them? If so, please provide feedback on these difficulties, challenges and needs for each of the identified processes or articles concerned. Click here to enter text. Question 6.2 In your opinion, what are the main benefits of the implementation and enforcement of the Directive (such as in comparison with the measures and the situation in place before that such legislation came into force)? Click here to enter text. Question 6.3 In your opinion, what measures or proposals could be implemented in order to improve the efficiency (relation between costs and effects) of the measures put in place to comply with the Directive? Click here to enter text. -----Original Message----- From: EC ARES NOREPLY [mailto:[email protected]] Sent: Thursday, June 7, 2018 5:01 PM Subject: Ares(2018)2987492 - Marine Equipment Directive – Cost- Effectiveness Analysis Veuillez trouver ci-joint le document Ares(2018)2987492 concernant "Marine Equipment Directive – Cost-Effectiveness Analysis" envoyé par M/Mme TOMASSINI Manuela le 07/06/2018. Please find attached document Ares(2018)2987492 regarding "Marine Equipment Directive – Cost-Effectiveness Analysis" sent by Mr/Ms TOMASSINI Manuela on 07/06/2018. Please note that the attached .pdf version of the MED CEA questionnaire is for information purposes. Shortly a customized word version of the questionnaire, pre-filled with some information available for your Member State, and to be compiled, will be sent to you from the dedicated email [email protected] ------------------------------------------------------------------------- ------------------------------------ Note: This e-mail was automatically generated by the European Commission's central mail registration system. Replies by e-mail must be addressed to the original sender TOMASSINI Manuela (mailto:[email protected]). Remarque : Cet e-mail a été généré automatiquement par le système d'enregistrement central du courrier de la Commission européenne. Toute réponse éventuelle par e-mail doit être adressée à l'expéditeur en personne, à savoir TOMASSINI Manuela (mailto:[email protected]). From: Cost-Effectiveness Analysis of Directive 2014/90/EU [mailto:[email protected]] Sent: Friday, June 8, 2018 3:13 PM To: Jaan Sääsk <[email protected]>; Marek Rauk <[email protected]>; VA_mot <[email protected]>; TJA - Avalik <[email protected]>; [email protected] Cc: CALCAGNO Guido (EMSA) <[email protected]>; ROTOLI Francesco (EMSA) <[email protected]>; BROISSIN CAPO Francisco (EMSA) <Francisco.Broissin- [email protected]>; Cost-Effectiveness Analysis of Directive 2014/90/EU <[email protected]> Subject: MED CEA Questionnaire Dear Competent Authorities of Estonia responsible for the implementation of the Directive 2014/90/EU on Marine Equipment (MED), with reference to the general MED Cost-Effectiveness Analysis questionnaire which has been sent by the Head of Department B, Mrs. Manuela Tomassini, with Ref. Ares(2018)2987492 – 07/06/2018, please find attached the customized word version of the questionnaire pre-filled with all the information available to us and concerning your Member State. We kindly ask your services to complete and return this word version to EMSA by 24 August 2018, using the following dedicated email: [email protected] Should you need any further information, please do not hesitate to contact us. Best regards, Guido Calcagno Senior Project Officer for Horizontal Analysis Analysis & Assessment Visits & Inspections EMSA / Praça Europa 4 / 1249-206 Lisbon / Portugal Tel +351 21 1209 470 / Fax +351 21 1209 215 [email protected] / emsa.europa.eu