MEDICAL DEVICES

IN VITRO DIAGNOSTIC MEDICAL DEVICES

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:

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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Strasbourg, 5 April 2017.

For the European Parliament

The President

A. TAJANI

For the Council

The President

I. BORG

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