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HE the Ambassador Permanent Representation of Estonia Rue Guimard 11–13 B-1040 Bruxelles BELGIUM 30 November 2022 EMA/914584/2022 Executive Director Your Excellency, Subject: Nomination of a representative in the Executive Steering Group on Shortages of Medical Devices of the European Medicines Agency (EMA) Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices lays down the procedures for coordinating and managing the impact of public health emergencies on medical devices at Union level. It foresees the establishment of the Executive Steering Group on Shortages of Medical Devices, the so-called ‘Medical Device Shortages Steering Group (MDSSG)’ within the Agency. The Executive Steering Group on Shortages of Medical Devices, among others, will: • coordinate urgent actions within the Union in relation to the management of supply and demand issues of medical devices; • establish a list of critical medical devices in the case of a public health emergency. Article 21(2) of Regulation (EU) No 2022/123 stipulates that the Executive Steering Group on Shortages of Medical Devices shall consist of a representative of the Agency, a representative of the Commission and one representative appointed by each Member State. Therefore, to allow the Agency to begin preparations for the new Executive Steering Group established by the Regulation, I am writing to ask you to nominate a member from your country. Please note that the formal appointment of MDSSG members will take place after Chapter IV of the Regulation becomes applicable on 2 February 2023. In making the nominations, I would like to draw your attention to the need for the Executive Steering Group members to be able to make decisions on behalf of their Member State in an urgent manner, even during meetings, to allow for timely and coordinated actions in the EU. For the full list of responsibilities of the MDSSG please refer to Annex I. In addition, I would like to highlight to you that Article 31 of Regulation (EU) No 2022/123 requires the Agency to ensure that the Executive Steering Group on Shortages and Safety of Medicinal products (MSSG) and the MDSSG cooperate in relation to Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2022. Reproduction is authorised provided the source is acknowledged. measures to address public health emergencies. Therefore, for Members States where the national competent authority is responsible for both medicines and medical devices, having the same nomination for the MDSSG as that of the MSSG will facilitate this cooperation. I would also like to remind you of the policy in place at the Agency regarding the handling of competing interests of scientific committees’ members and experts, which will also be applied to members of the new Executive Steering Group. For further details please use the following link (EMA Policy 0044 - Handling of competing interests). In making the nomination for your Member State, please ensure that the nominee is or will be included in the Agency’s European experts list with a declaration of interests (DoI) and CV as this is a requirement before a member can be involved in the activities of the Executive Steering Group. The contact point for the Agency’s Experts database in your Member State can be of assistance for this inclusion in the European experts list. As the current DoI form is not yet adapted for medical devices, the nominee is requested to declare any interest in a medical device company in section 2.10 ‘Any other interests or facts’ of the DoI form, providing in that section the information on medical devices in the same way as for pharmaceutical industry interests from section 2.1 to 2.8, i.e. employment, consultancy, strategic advisory role, financial interests, principal investigator, investigator, grant/funding to organisation/institution and close family members. It is anticipated that the Medical Device Shortages Steering Group will convene its first virtual meeting on 23 February 2023, thereafter meetings will be held at the European Medicines Agency in Amsterdam or will be held remotely. A response by Friday 13 January 2023 would therefore be appreciated. Please address your nominations to my attention, indicating full contact details for your nominee along with the nominee’s CV and declaration of interest if not included in the European experts list. A copy of this letter will be shared with the head of the relevant competent authorities in your country. Yours faithfully Digitally signed by Emer Cooke Emer Cooke Date: 2022.11.30 18:22:28 +01'00' Emer Cooke Executive Director Enc.: Annex I List of responsibilities of the MDSSG Nomination of a representative in the Executive Steering Group on Shortages of Medical Devices of the European Medicines Agency EMA/914584/2022 Page 2/3 ANNEX I LIST OF RESPONSIBILITIES OF THE MDSSG Where the public health emergency may lead to shortages of medical devices in more than one Member State the MDSSG will: a) Adopt a list of medical devices considered as critical during the public health emergency “public health emergency critical devices list”. The list shall be updated whenever necessary until the termination of the recognition of the public health emergency. b) Adopt and make publicly available a set of information necessary to monitor the supply and demand for medical devices included on the public health emergency critical devices list; c) Monitor supply and demand of medical devices included on the public health emergency critical devices list with a view to identifying any potential or actual shortages of those medical devices; d) Report regularly the results of its monitoring to the Commission and the medical devices shortage SPOC working party, and, in particular, signal any potential or actual shortages of medical devices included on the public health emergency critical devices list. e) Provide aggregated data and forecasts of demand to the Commission or the sub-networks. The MDSSG will liaise with the European Centre for Disease Prevention and Control (ECDC) to obtain epidemiological data to help forecast medical device needs, and with the Executive Steering Group on Shortages of Medicinal Products where medical devices included on the public health emergency critical devices list are used jointly with a medicinal product. The findings and conclusions of the aggregated data and forecasts of demand may also be made available to other actors in the medical device sector, where relevant, and in accordance with competition rules with a view to better prevent or mitigate potential or actual shortages; f) Liaise with the Medical Devices Coordination Group (MDCG) and the Health Security Committee (HSC) and, in the case of a public health emergency, any other advisory committee on public health emergencies established pursuant to Union law as well as with the ECDC; g) Develop recommendations and coordinate measures (including crisis communication), which may be taken by the Commission, Member States, medical device manufacturers, notified bodies and other entities, to prevent or mitigate potential or actual shortages of medical devices; Nomination of a representative in the Executive Steering Group on Shortages of Medical Devices of the European Medicines Agency EMA/914584/2022 Page 3/3 Saatja: Chambers Pia <[email protected]> Saaja: Esindus EL juures üldaadress Teema: Executive Steering Group on Shortages of Medical Devices - Estonia Your Excellency, Please find attached a letter signed by the European Medicines Agency's Executive Director requesting the nomination of a representative to the Agency's Executive Steering Group on Shortages of Medical Devices (MDSSG). The letter is accompanied by an Annex compiling the responsibilities of the MDSSG. Kindly note that members of the MDSSG will have to make decisions in an urgent manner, to allow for timely and coordinated actions in the EU. You are kindly invited to address nominations to the European Medicines Agency’s Executive Director Emer Cooke at your earliest convenience, by 13 January 2023. Please do not hesitate to contact us should you have any questions regarding this request for nomination. Yours sincerely, MDSSG Secretariat Pia Chambers Supply and Availability of Medicines and Devices (SAM) Regulatory Science and Innovation Task Force (TRS) European Medicines Agency Domenico Scarlattilaan 6 | 1083 HS Amsterdam | The Netherlands Telephone +31 (0)88 781 7106 [email protected]<mailto:[email protected]> | www.ema.europa.eu<https://www.ema.europa.eu/en> | For directions, see How to find us<https://www.ema.europa.eu/en/about-us/contact/how-find-us> This message and any attachment contain information which may be confidential or otherwise protected from disclosure. It is intended for the addressee(s) only and should not be relied upon as legal advice unless it is otherwise stated. If you are not the intended recipient(s) (or authorised by an addressee who received this message), access to this e-mail, or any disclosure or copying of its contents, or any action taken (or not taken) in reliance on it is unauthorised and may be unlawful. If you have received this e-mail in error, please inform the sender immediately. Classified as confidential by the European Medicines Agency Saatja: Webdesktop <[email protected]> Saadetud: 02.12.2022 11:00 Adressaat: <[email protected]>; <[email protected]> Koopia: SM Info <[email protected]>; Agne Nettan-Sepp Brüsselis <agne.nettan- [email protected]>; Elen Ohov <[email protected]> Teema: Webdesktop: Esindajate nimetamine Euroopa Ravimiameti komiteesse (MDSSG) Tere!Edastan Euroopa Ravimiameti kirja, mille jõudsin juba saata EE Ravimiametisse. Sealt vastati, et meditsiiniseadmed on Terviseameti valdkond.Reg. number: 14-4/1232Reg. kuupäev: 01.12.2022Sisu: Nomination of a representative in the Executive Steering Group on Shortages of Medical Devices (MDSSG) of the European Medicines Agency (EMA)Vastamise tähtaeg on 13.01.2023 ja käib esinduse kaudu. Palun saatke info enne nimetamise tähtaega aadressil [email protected] . Parimate soovidegaTiiu [email protected]är, EV alaline esindus EL juures