This document is an excerpt from the EUR-Lex website
Ensuring the safety and performance of medical devices
Besides medical devices, the regulation also covers certain groups of products which do not have an intended medical purpose. These include coloured contact lenses (i.e. lenses that do not correct vision) and liposuction equipment. A list of these products is included in Annex XVI to the regulation.
Medical devices are classified according to their intended purpose and their inherent risks (classes I, IIa, IIb and III as set out in Annex VIII to the regulation).
Obligations of manufacturers and other economic operators
The regulation introduces a system for registering devices and manufacturers, importers and authorised representatives to ensure the traceability of devices throughout the supply chain by means of a unique device identifier. This will ensure that measures can be taken rapidly if problems arise.
These devices may only be reprocessed (cleaned, disinfected, tested, restored for technical and functional safety and sterilised) if permitted under national law and if they meet certain conditions laid down in this regulation. Any individual or legal person who reprocesses a single-use device to make it suitable for further use assumes the obligations of a manufacturer. In certain cases, Member States may allow for exceptions to the general rules where the single-use device is reprocessed and used within a health institution, provided that certain specific requirements laid down in the regulation are fulfilled.
In addition to the obligation for manufacturers to report serious incidents and trends in non-serious incidents, the regulation introduces obligations for Member States to encourage and enable healthcare professionals, users and patients to report suspected incidents at the national level using standardised formats.
The relevant EU authorities are responsible for ensuring that any unsafe or non-compliant device is not placed on the market, or is withdrawn from the market if found to be unsafe after being placed on the market.
A centralised system, the European database on medical devices (Eudamed), will be developed to provide Member States, economic operators, patients, healthcare professionals and the public with information on medical devices available in the EU.
In the case of implantable devices, manufacturers must provide patients with key information on an implant card delivered with the device. This includes:
Repeal of existing legislation – Directives 90/385/EEC and 93/42/EEC
The regulation, as amended by Regulation (EU) 2020/561, repeals Directives 90/385/EEC and 93/42/EEC from 26 May 2021, laying down specific transitional rules and some exceptions in Articles 120 and 122.
It entered into force on 25 May 2017 and, further to amending Regulation (EU) 2020/561, has applied from 26 May 2021, 1 year later than originally intended. However, the dates of application for some of the regulation’s rules vary and are detailed in Articles 120, 122 and 123, as amended.
It does not achieve its principal intended action by pharmacological, immunological or metabolic means, but the latter may assist in its function. Examples range from bandages through hip replacements to pacemakers. The complete definition of the term medical device is laid down in Article 2(1) of Regulation (EU) 2017/745.
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 (OJ L 117, 5.5.2017, pp. 1–175).
Successive amendments to Regulation (EU) 2017/745 have been incorporated into the original text. This consolidated version is of documentary value only.
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, pp. 176–332).
See consolidated version.
last update 27.01.2022