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EU MDR
Dynamic EU MDR 2017/745 Full Text
Chapter 1 (Art 1 - 4) Scope and definitions
Chapter 2 (Art 5 - 24) – Making available on the market and putting into service of devices, obligations of economic operators, reprocessing, CE marking, free movement
Chapter 3 (Art 25 - 34) – Identification and traceability of devices, registration of devices and of economic operators, summary of safety and clinical performance, European database on medical devices
Chapter 4 (Art 35 - 50) – Notified bodies
Chapter 5 (Art. 51 – 60) Classification and conformity assessment
Chapter 6 (Art. 61 – 82) Clinical evaluation and clinical investigations
Chapter 7 (Art. 83 – 100) Post-market surveillance, vigilance and market surveillance
Chapter 8 (Art. 101 – 108) Cooperation between member states, medical device coordination group, expert laboratories, expert panels and device registers
Chapter 9 (Art. 109 – 113) Confidentiality, data protection, funding and penalties
Chapter 10 (Art. 114 – 123) Final provisions
Annexes
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Chapter 5 (Art. 51 – 60) Classification and conformity assessment

Article 54 – Clinical evaluation consultation procedure for certain class III and class IIb devices

In addition to the procedures applicable pursuant to
Article 52
⁠
, a notified body shall also follow the procedure regarding clinical evaluation consultation as specified in Section 5.1 of
Annex IX
⁠
or as referred to in Section 6 of
Annex X
⁠
, as applicable, when performing a conformity assessment of the following devices:
class III implantable devices, and
class IIb active devices intended to administer and/or remove a medicinal product, as referred to in Section 6.4 of
Annex VIII
⁠
(Rule 12).
The procedure referred to in paragraph 1 shall not be required for the devices referred to therein:
in the case of renewal of a certificate issued under this Regulation;
where the device has been designed by modifying a device already marketed by the same manufacturer for the same intended purpose, provided that the manufacturer has demonstrated to the satisfaction of the notified body that the modifications do not adversely affect the benefit-risk ratio of the device; or
where the principles of the clinical evaluation of the device type or category have been addressed in a CS referred to in
Article 9
⁠
and the notified body confirms that the clinical evaluation of the manufacturer for this device is in compliance with the relevant CS for clinical evaluation of that kind of device.
The notified body shall notify the competent authorities, the authority responsible for notified bodies and the Commission through the electronic system referred to in
Article 57
⁠
of whether or not the procedure referred to in paragraph 1 of this Article is to be applied. That notification shall be accompanied by the clinical evaluation assessment report.
The Commission shall draw up an annual overview of devices which have been subject to the procedure specified in Section 5.1 of
Annex IX
⁠
and referred to in Section 6 of
Annex X
⁠
. The annual overview shall include the notifications in accordance with paragraph 3 of this Article and point (e) of Section 5.1 of
Annex IX
⁠
and a listing of the cases where the notified body did not follow the advice from the expert panel. The Commission shall submit this overview to the European Parliament, to the Council and to the MDCG.
The Commission shall by 27 May 2025 draw up a report on the operation of this Article and submit it to the European Parliament and to the Council. The report shall take into account the annual overviews and any available relevant recommendations from the MDCG. On the basis of that report the Commission shall, if appropriate, make proposals for amendments to this Regulation.
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