Article 123: 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 2020.
3. By way of derogation from paragraph 2:
(a) Articles 35 to 50 shall apply from 26 November 2017. However, from that date until 26 May 2020, the obligations on notified bodies pursuant to Articles 35 to 50 shall apply only to those bodies which submit an application for designation in accordance with Article 38;
(c) Article 102 shall apply from 26 May 2018;
(d) without prejudice to the obligations on the Commission pursuant to Article 34, where, due to circumstances that could not reasonably have been foreseen when drafting the plan referred to in Article 34(1), Eudamed is not fully functional on 26 May 2020, 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). The provisions referred to in the preceding sentence are:
- Article 29,
- Article 31,
- Article 32,
- Article 33(4),
- the second sentence of Article 40(2),
- Article 42(10),
- Article 43(2),
- the second subparagraph of Article 44(12),
- points (d) and (e) of Article 46(7),
- Article 53(2),
- Article 54(3),
- Article 55(1),
- Articles 70 to 77,
- paragraphs 1 to 13 of Article 78,
- Articles 79 to 82,
- Article 86(2),
- Articles 87 and 88,
- Article 89(5) and (7), and the third subparagraph of Article 89(8),
- Article 90,
- Article 93(4), (7) and (8),
- Article 95(2) and (4),
- the last sentence of Article 97(2),
- Article 99(4),
- the second sentence of the first subparagraph of Article 120(3).
Until Eudamed is fully functional, the corresponding provisions of Directives 90/385/EEC and 93/42/EEC 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 vigilance reporting, clinical investigations, registration of devices and economic operators, and certificate notifications.
(f) for implantable devices and for class III devices Article 27(4) shall apply from 26 May 2021. For class IIa and class IIb devices Article 27(4) shall apply from 26 May 2023. For class I devices Article 27(4) shall apply from 26 May 2025;
(g) for reusable devices that shall bear the UDI carrier on the device itself, Article 27(4) shall apply from two years after the date referred to in point (f) of this paragraph for the respective class of devices in that point;
(h) The procedure set out in Article 78 shall apply from 26 May 2027, without prejudice to Article 78(14);
(i) Article 120(12) 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
For the Council