Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisionsText with EEA relevance.

Article 9(9) of Directive 90/385/EEC and Article 11(13) of Directive 93/42/EEC, which are repealed with effect from 24 April 2020.;

(8) Article 123 is amended as follows:

(a) in paragraph 2, the date 26 May 2020 is replaced by 26 May 2021;

(b) paragraph 3 is amended as follows:

(i) in point (a), the date 26 May 2020 is replaced by 26 May 2021;

(ii) in the first sentence of point (d), the date 26 May 2020 is replaced by 26 May 2021;

(iii) point (g) is replaced by the following:

(g) with regard to reusable devices that are required to bear the UDI carrier on the device itself, Article 27(4) shall apply to:

(i) implantable devices and class III devices from 26 May 2023;

(ii) class IIa and class IIb devices from 26 May 2025;

(iii) class I devices from 26 May 2027;;

(iv) the following point is added:

(j) Article 59 shall apply from 24 April 2020.;

(9) in point (h) of Section 5.1 of Annex IX, the date 26 May 2020 is replaced by 26 May 2021.

Article 2

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

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

Done at Brussels, 23 April 2020.

For the European Parliament

The President

D.M. Sassoli

For the Council

The President

G. Grlić Radman