EU MDR

Chapter 1 (Art 1 - 4) Scope and definitions

Chapter 2 (Art 5 - 24) – Making available on the market and putting into service of devices, obligations of economic operators, reprocessing, CE marking, free movement

Chapter 3 (Art 25 - 34) – Identification and traceability of devices, registration of devices and of economic operators, summary of safety and clinical performance, European database on medical devices

Chapter 4 (Art 35 - 50) – Notified bodies

Chapter 5 (Art. 51 – 60) Classification and conformity assessment

Chapter 6 (Art. 61 – 82) Clinical evaluation and clinical investigations

Chapter 7 (Art. 83 – 100) Post-market surveillance, vigilance and market surveillance

Chapter 8 (Art. 101 – 108) Cooperation between member states, medical device coordination group, expert laboratories, expert panels and device registers

Chapter 9 (Art. 109 – 113) Confidentiality, data protection, funding and penalties

Chapter 10 (Art. 114 – 123) Final provisions

Annexes

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Chapter 10 (Art. 114 – 123) Final provisions

Article 123 – Entry into force and date of application

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

It shall apply from 26 May 2021.

By way of derogation from paragraph 2:

⁠

Articles 35⁠

50⁠

shall apply from 26 November 2017. However, from that date until 26 May 2021, the obligations on notified bodies pursuant to

Articles 35⁠

50⁠

shall apply only to those bodies which submit an application for designation in accordance with

Article 38⁠

;

⁠

Articles 101⁠

and

103⁠

shall apply from 26 November 2017;

⁠

Article 102⁠

shall apply from 26 May 2018;

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 56(5)⁠

⁠

Article 55(1)⁠

⁠

Articles 70⁠

77⁠

⁠

Article 78(1) to (13)⁠

, without prejudice to

Article 78(14)⁠

⁠

Articles 79⁠

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

(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.

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:

devices, other than custom-made devices, for which the manufacturer has undertaken a conformity assessment in accordance with

Article 52⁠

⁠

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

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;

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

implantable devices and class III devices from 26 May 2023

implantable devices and class III devices from 26 May 2023; class IIa and class IIb devices from 26 May 2025;

class I devices from 26 May 2027;

⁠

Article 120(12)⁠

shall apply from 26 May 2019.

Article 59 shall apply from 24 April 2020.

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

⁠

⏳ Article 123(2), 123(3) amended by

Regulation 2020/561⁠

⁠

⏳ Article 123(3) amended by

Regulation 2023/607⁠

⁠

⏳ Article 123(3)(d) and 123(3)(e) amended by

Regulation 2024/1860⁠

⁠

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