Regulation (EU) 2017/746 of the European Parliament and of the CouncilDangos y teitl llawn

Article 113 Entry into force and date of application

1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

2. It shall apply from 26 May 2022.

3. By way of derogation from paragraph 2:

(a) Article 27(3) and Article 51(5) shall apply from 27 November 2023;

(b) Articles 31 to 46 and Article 96 shall apply from 26 November 2017. However, from that date until 26 May 2022 the obligations on notified bodies pursuant to Articles 31 to 46 shall apply only to those bodies which submit an application for designation in accordance with Article 34;

(c) Article 97 shall apply from 26 May 2018;

(d) Article 100 shall apply from 25 November 2020;

(e) for class D devices, Article 24(4) shall apply from 26 May 2023. For class B and class C devices Article 24(4) shall apply from 26 May 2025. For class A devices Article 24(4) shall apply from 26 May 2027;

(f) without prejudice to the obligations on the Commission pursuant to Article 34 of Regulation (EU) 2017/745, where, due to circumstances that could not reasonably have been foreseen when drafting the plan referred to in Article 34(1) of that Regulation, Eudamed is not fully functional on 26 May 2022, the obligations and requirements that relate to Eudamed shall apply from the date corresponding to six months after the date of publication of the notice referred to in Article 34(3) of that Regulation. The provisions referred to in the preceding sentence are:

• (f) Article 26,

• Article 28,

• Article 29,

• the second sentence of Article 36(2),

• Article 38(10),

• Article 39(2),

• the second subparagraph of Article 40(12),

• points (d) and (e) of Article 42(7),

• Article 49(2),

• Article 50(1),

• Articles 66 to 73,

• paragraphs 1 to 13 of Article 74,

• Articles 75 to 77,

• Article 81(2),

• Articles 82 and 83,

• Article 84(5) and (7) and the third subparagraph of Article 84(8),

• Article 85,

• Article 88(4), (7) and (8),

• Article 90(2) and (4),

• the last sentence of Article 92(2),

• Article 94(4),

• the second sentence of the first subparagraph of Article 110(3).

Until Eudamed is fully functional the corresponding provisions of Directive 98/79/EC shall continue to apply for the purpose of meeting the obligations laid down in the provisions listed in the first paragraph of this point regarding exchange of information including, and in particular, information regarding performance studies, vigilance reporting, registration of devices and economic operators, and certificate notifications.

(g) The procedure set out in Article 74 shall, apply from 26 May 2027 without prejudice to Article 74(14).

(h) Article 110(10) shall apply from 26 May 2019.