Maret Ots
Saatja: Maret Ots
Saatmisaeg: 24. jaanuar 2018. a. 14:13
Adressaat: '
[email protected]'
Teema: Draft guide documents - Estonian comments
Dear Nikos,
Thank you for the guidance documents, these are very useful for our work.
We have discussed the guides in Estonian Technical Regulatory Authority and we have some comments.
„Applicability of the LVD/EMCD/RED to Specific Categories of Products”
2 “Finished products (examples)”
The text especially examples in this section are confusing. There is no clear guidance for economic operators.
Considering the examples different economic operators can decide differently when dealing the similar case. We are
waiting for more explanation when examples are made. If you will leave this section as it is then market surveillance
authorities will be in big trouble when solving problems with non-compliant products.
The section “Finished products” have to be revised. If you have intention to publish the guide soon then this section
should be excluded from the document as confusing.
„Guide to the Radio Equipment Directive 2014/53/EU”.
1.6.3 3 Products that use electromagnetic waves exclusively for other purposes than radio communication and/or
radiodetermination
In the last TCAM COCIR (European Coordination Committee of the Radiological, Electromedical and Healthcare IT
Industry) explained why MRI (Medical Magnetic Resonance Imagining) equipment is outside the RED.
There is not text MRI equipment in the RED Guide now. We propose not exclude the MRI equipment from the RED
at this stage.
We would like to draw your attention to the item in ETSI working plan. ETSI is preparing a new document TR
103 517 System Reference document (SRdoc); Short Range Devices (SRD) using Nuclear Magnetic Resonance (NMR);
Technical characteristics for SRD equipment using Nuclear Magnetic Resonance (NMR) technology in the frequency
range 1 MHz to 50 MHz. the work is in progress . It is very useful to have this document before to make the decision
about MRI equipment. You can ask about this document from ETSI to have more information about this topic.
1.6.3.9 Construction kits/components
The second paragraph in this section consists only from one single sentence (11 rows). It is very difficult to
understand what is the point of this text. The guide should be written unambiguously and clearly. The text in this
paragraph should be revised.
Best regards
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Maret Ots
Chief Specialist of Frequency Management Department
+372 667 2092|
[email protected] | www.tja.ee
Technical Regulatory Authority
Sõle 23A, 10614 Tallinn, Estonia
From:
[email protected] [mailto:
[email protected]]
Sent: Monday, December 11, 2017 12:34 PM
To: Maret Ots <
[email protected]>
Subject: draft guidance documents
Dear All
During the last TCAM WG meeting (held on 1 December 2017) you have been invited to send your
comments (if any) by 31 January 2018 on the following draft documents:
- Applicability of the LVD/EMCD/RED to Specific Categories of Products;
-draft RED Guide.
Both draft documents are attached (follow the link below)and you may make any comments on these
versions, since they already include the comments made and agreed during the last TCAM WG meeting.
It is noted that the document with title 'Applicability of the LVD/EMCD/RED to Specific Categories of
Products' does not include the previous draft conclusion on 'several products'. Instead it now includes the
following:
-examples of what constitutes finished products under LVD/EMCD/RED;
-combination of several finished products within the sense of the EMCD (which follows, subject to
adaptations, the conclusion included in the Guide for the old EMCD).
You may send your comments-if any:
-to:
[email protected]
-by: 31 January 2018
It is noted that the Commission service does not commit to provide specific replies to any comments
received.
Kind Regards,
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NIKOS MICHAILIDIS
European Commission
DG Internal Market, Industry, Entrepreneurship and SME
Engineering Industries
BREY 10/186, B-1049 Brussels/Belgium
Tel.: +32-2-2952906, Fax : +32-2-2966273
[email protected]
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20171207 guidance documents.docx
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