Address https://gelex.eu/eli/EU/decision/2025/2371@2025-11-26/en

Contents

1. Preamble
2. 1. Article 1
   2. Article 2

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, and in particular Article 34(3) thereof,

Whereas:

(1) According to Article 33(1) of Regulation (EU) 2017/745 and Article 30(1) of Regulation (EU) 2017/746 of the European Parliament and of the Council, the Commission is to set up, maintain and manage the European Database on Medical Devices (Eudamed). Eudamed is to include the electronic systems listed in Article 33(2) of Regulation (EU) 2017/745 and Article 30(2) of Regulation (EU) 2017/746.

(2) On 15 December 2022, the Commission published the latest consolidated version of the functional specifications of Eudamed (version 7.2), which it had drawn up in collaboration with the Medical Device Coordination Group (MDCG) in accordance with Article 34(1) of Regulation (EU) 2017/745.

(3) In accordance with Article 34(2) of Regulation (EU) 2017/745, the Commission requested an independent audit on the Eudamed electronic systems for which the development has been completed. Such electronic systems are the electronic system on registration of economic operators (Actors), the UDI database and the electronic system for registration of devices (UDI and devices), the electronic system on notified bodies and certificates (Notified bodies and certificates), and the electronic system on market surveillance (Market surveillance).

(4) On the basis of the independent audit report of 18 June 2025 on the Actors, UDI and devices, Notified bodies and certificates, and Market surveillance electronic systems, the Commission has verified that such electronic systems are functional and meet the relevant functional specifications drawn up pursuant to Article 34(1) of Regulation (EU) 2017/745.

(5) As set out in Article 123(3), points (d) to (ec), of Regulation (EU) 2017/745 and Article 113(3), points (f) to (fd) of Regulation (EU) 2017/746, the transition periods for the obligations and requirements that relate to any of the electronic systems referred to in those Regulations are to start as from the date of publication of this Decision on the notice as referred to in Article 34(3) of Regulation (EU) 2017/745, informing that the relevant electronic systems are functional and meet the functional specifications.

(6) In order to ensure legal certainty and a clear timeline for the mandatory use of the electronic systems declared functional, this Decision should enter into force on the day of its publication.

HAS ADOPTED THIS DECISION:

Article 1

It is hereby confirmed that the following electronic systems included in the European Database on Medical Devices (Eudamed) have achieved functionality and meet the functional specifications, as referred to in Article 34(2) of Regulation (EU) 2017/745: (a) the electronic system on registration of economic operators referred to in Article 30 of Regulation (EU) 2017/745 and Article 27 of Regulation (EU) 2017/746; (b) the UDI database and the electronic system for registration of devices referred to in Articles 28 and 29 of Regulation (EU) 2017/745 and Articles 25 and 26 of Regulation (EU) 2017/746; (c) the electronic system on notified bodies and certificates referred to in Article 57 of Regulation (EU) 2017/745 and Article 52 of Regulation (EU) 2017/746; (d) the electronic system on market surveillance referred to in Article 100 of Regulation (EU) 2017/745 and Article 95 of Regulation (EU) 2017/746.

(a) the electronic system on registration of economic operators referred to in Article 30 of Regulation (EU) 2017/745 and Article 27 of Regulation (EU) 2017/746;

(b) the UDI database and the electronic system for registration of devices referred to in Articles 28 and 29 of Regulation (EU) 2017/745 and Articles 25 and 26 of Regulation (EU) 2017/746;

(c) the electronic system on notified bodies and certificates referred to in Article 57 of Regulation (EU) 2017/745 and Article 52 of Regulation (EU) 2017/746;

(d) the electronic system on market surveillance referred to in Article 100 of Regulation (EU) 2017/745 and Article 95 of Regulation (EU) 2017/746.

Article 2

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

Done at Brussels, 26 November 2025. For the Commission The President Ursula von der Leyen

Versions

1. 2025-11-26

Cited by

• Council Decision (EU) 2026/1535 of 25 June 2026 on the position to be adopted on behalf of the European Union within the Joint Committee established by the Agreement between the European Community and the Principality of Monaco on the application of certain Community acts on the territory of the Principality of Monaco concerning amendments to the Annex to that Agreement Decision · Grade B

  MEDICAL DEVICES Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.7.1990, p. 17). Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1). Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1). Commission Decision 2002/364/EC of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices (OJ L 131, 16.5.2002, p. 17), as am