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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 10 (Art. 114 – 123) Final provisions

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Article 122 – Repeal

Without prejudice to
Articles 120(3)
⁠
to 3(e) and (4) of this Regulation, and without prejudice to the obligations of the Member States and manufacturers as regards vigilance and to the obligations of manufacturers as regards the making available of documentation, under Directives 90/385/EEC and 93/42/EEC, those Directives are repealed with effect from 26 May 2021, with the exception of:
Articles 8 and 10, Article 10b(1), points (b) and (c), and Article 10b(2) and (3) of Directive 90/385/EEC, Article 10, Article 14a(1), points (c) and (d), Article 14a(2) and (3) and Article 15 of Directive 93/42/EEC, and the obligations relating to vigilance and clinical investigations provided for in the corresponding Annexes to those Directives, which are repealed, as applicable, with effect from the date referred to in Article 123(3), point (d), of this Regulation in respect of the application of the obligations and requirements that relate to the electronic systems referred to in Article 33(2), points (e) and (f), respectively, of this Regulation;
Article 10a, Article 10b(1), point (a), and Article 11(5) of Directive 90/385/EEC, Article 14(1) and (2), Article 14a(1), points (a) and (b), and Article 16(5) of Directive 93/42/EEC, and the obligations relating to registration of devices and economic operators, and to certificate notifications, provided for in the corresponding Annexes to those Directives, which are repealed, as applicable, with effect from the date referred to in Article 123(3), point (d), of this Regulation in respect of the application of the obligations and requirements that relate to the electronic systems referred to in Article 33(2), points (a) to (d), respectively, of this Regulation;
Article 9(9) of Directive 90/385/EEC and Article 11(13) of Directive 93/42/EEC, which are repealed with effect from 24 April 2020.
As regards the devices referred to in Article 120(3) to (3e) and (4) of this Regulation, the Directives referred to in the first paragraph of this Article shall continue to apply to the extent necessary for the application of those paragraphs.
Notwithstanding the first paragraph, Regulations (EU) No 207/2012 and (EU) No 722/2012 shall remain in force and continue to apply unless and until repealed by implementing acts adopted by the Commission pursuant to this Regulation.
References to the repealed Directives shall be understood as references to this Regulation and shall be read in accordance with the correlation table laid down in
Annex XVII
⁠
to this Regulation.

⁠
⏳ Article 122 amended by
Regulation 2020/561
⁠
,
Regulation 2023/607
⁠
and
Regulation 2024/1860
⁠
⁠
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