EU MDR

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 2 (Art 5 - 24) – Making available on the market and putting into service of devices, obligations of economic operators, reprocessing, CE marking, free movement

Article 9 – Common specifications

Without prejudice to

Article 1(2)⁠

and

17(5)⁠

and the deadline laid down in those provisions, where no harmonised standards exist or where relevant harmonised standards are not sufficient, or where there is a need to address public health concerns, the Commission, after having consulted the MDCG, may, by means of implementing acts, adopt common specifications (CS) in respect of the general safety and performance requirements set out in

Annex I⁠

, the technical documentation set out in

Annexes II⁠

and

III⁠

, the clinical evaluation and post-market clinical follow-up set out in

Annex XIV⁠

or the requirements regarding clinical investigation set out in

Annex XV⁠

. Those implementing acts shall be adopted in accordance with the examination procedure referred to in

Article 114(3)⁠

Devices that are in conformity with the CS referred to in paragraph 1 shall be presumed to be in conformity with the requirements of this Regulation covered by those CS or the relevant parts of those CS.

Manufacturers shall comply with the CS referred to in paragraph 1 unless they can duly justify that they have adopted solutions that ensure a level of safety and performance that is at least equivalent thereto.

Notwithstanding paragraph 3, manufacturers of products listed in

Annex XVI⁠

shall comply with the relevant CS for those products.

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