Medical devices

Directive 93/42/EEC aims to protect the human health and safety, smooth operation of the single market and to achieve the results for which the devices are intended.

National authorities must ensure that all medical devices available in the EU are safe for patients, users and others when they are properly installed, maintained and used as they should be.

Legal act: 
Regulation (EU) 2017/745 and Directive 93/42/EEC until 25/05/2020 (Partial end of validity)

Parts of Directive 93/42/EEC that remain active:
Regulation (EU) 2017/745, Article 122 - Repeal
Without prejudice to Articles 120(3) and (4) of this Regulation, and without prejudice to the obligations of the Member States and manufacturers as regards vigilance and to the obligations of manufacturers as regards the making available of documentation, under Directives 90/385/EEC and 93/42/EEC, those Directives are repealed with effect from 26 May 2020, with the exception of:

  • Articles 8 and 10, points (b) and (c) of Article 10b(1), Article 10b(2) and Article 10b(3) of Directive 90/385/EEC, and the obligations relating to vigilance and clinical investigations provided for in the corresponding Annexes, which are repealed with effect from the later of the dates referred to in point (d) of Article 123(3) of this Regulation;
  • Article 10a and point (a) of Article 10b(1) of Directive 90/385/EEC, and the obligations relating to registration of devices and economic operators, and to certificate notifications, provided for in the corresponding Annexes, which are repealed with effect from 18 months after the later of the dates referred to in point (d) of Article 123(3) of this Regulation;
  • Article 10, points (c) and (d) of Article 14a(1), Article 14a(2), Article 14a(3) and Article 15 of Directive 93/42/EEC, and the obligations relating to vigilance and clinical investigations provided for in the corresponding Annexes, which are repealed with effect from the later of the dates referred to in point (d) of Article 123(3) of this Regulation; and
  • Article 14(1) and (2) and points (a) and (b) of Article 14a(1) of Directive 93/42/EEC, and the obligations relating to registration of devices and economic operators, and to certificate notifications, provided for in the corresponding Annexes, which are repealed with effect from 18 months after the later of the dates referred to in point (d) of Article 123(3) of this Regulation.

As regards the devices referred to in Article 120 (3) and (4) of this Regulation, the Directives referred to in the first paragraph shall continue to apply until 27 May 2025 to the extent necessary for the application of those paragraphs.

Consolidated act:
05/05/2017 of Regulation (EU) 2017/745

11/10/2007 of Directive 93/42/EEC

Legal acts repealed by Regulation (EU) 2017/745:

Directive 93/42/EEC (Partial repeal from 26/05/2020)

Directive 90/385/EEC (Partial repeal from 26/05/2020, See Active implantable medical devices)

Legal acts repealed by Directive 93/42/EEC:

Directive 76/764/EEC

Previous guidelines:

Guidelines on Medical Devices - Guidelines for competent authorities for making a validation/assessment of a clinical investigation application under Directives 93/42/EEC and 90/385/EEC, 12 October 2015

Guidelines on a Medical Devices vigilance system, January 2013

Additional Guidance Regarding the Vigilance System