Article 123: Entry into force and date of application

Location:

Chapter X

Source:

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 2021.

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 2021, 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;

(b) Articles 101 and 103 shall apply from 26 November 2017;

(d) without prejudice to the obligations of the Commission pursuant to Article 34, the obligations and requirements that relate to any of the electronic systems referred to in Article 33(2) shall apply from the date corresponding to 6 months from the date of publication of the notice referred to in Article 34(3), informing that the relevant electronic system is functional and meets the functional specifications drawn up pursuant to Article 34(1). 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),

— Article 56(5),

— Articles 70 to 77,

— Article 78(1) to (13), without prejudice to Article 78(14),

— 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),

— Article 120(3d).

Until the date of application of the provisions referred to in the first subparagraph of this point, the corresponding provisions of Directives 90/385/EEC and 93/42/EEC regarding information on vigilance reporting, clinical investigations, registration of devices and economic operators, and certificate notifications shall continue to apply.

(e) no later than 12 months from the date of publication of the notice referred to in Article 34(3) in respect of the electronic system referred to in Article 33(2), points (a) and (b), manufacturers shall ensure that the information to be entered in Eudamed in accordance with Article 29 is entered in that electronic system, including regarding the following devices, provided that those devices are also placed on the market from 6 months from the date of publication of that notice:

(i) devices, other than custom-made devices, for which the manufacturer has undertaken a conformity assessment in accordance with Article 52;

(ii) devices, other than custom-made devices, placed on the market pursuant to Article 120(3), (3a) or (3b), unless the device, for which the manufacturer has undertaken a conformity assessment in accordance with Article 52, is already registered in Eudamed;

(ea) no later than 18 months from the date of publication of the notice referred to in Article 34(3) in respect of the electronic system referred to in Article 33(2), point (d), notified bodies shall ensure that the information to be entered in Eudamed in accordance with Article 56(5) is entered in that electronic system, including regarding devices referred to in point (e)(i) of this paragraph; for those devices, only the latest relevant certificate and, where applicable, any subsequent decision taken by the notified body related to such certificate shall be entered;

(eb) by way of derogation from point (d), first subparagraph, of this paragraph, the obligations to upload the summary of safety and clinical performance in accordance with Article 32(1) and to notify competent authorities in accordance with Article 55(1), through the electronic system referred in Article 33(2), point (d), shall apply to devices referred to in point (e) of this paragraph when the certificate is entered in Eudamed in accordance with point (ea) of this paragraph;

(ec) without prejudice to point (d), first subparagraph, of this paragraph, when a manufacturer is to submit a PSUR in accordance with Article 86(2) of this Regulation, to report a serious incident or a field safety corrective action in accordance with Article 87 of this Regulation, or to submit a trend report in accordance with Article 88 of this Regulation through the electronic system referred to in Article 33(2), point (f), of this Regulation, it shall also register the device, which is the subject of the PSUR or the vigilance reporting, in the electronic system referred to in Article 33(2), points (a) and (b), of this Regulation, except if such device was placed on the market in accordance with Directive 90/385/EEC or 93/42/EEC;

(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) 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;

(i) Article 120(12) shall apply from 26 May 2019;

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

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