19 June 21 | Lisboa
Medical Devices

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April on medical devices.

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April on medical devices.

On 26 May 2021, Regulation (EU) 2017/745 of 5 April entered into force, establishing a single regime applicable to all medical devices, except in vitro diagnostic medical devices.

This Regulation amends 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 introduces some amendments, namely:

  1. a wider range of the concept of medical device and the application of its regime, medical devices without a medical purpose which have characteristics similar to medical devices, as well as those which incorporate non-viable cell or tissue derivatives of human origin and predictive genetic tests are now covered by the regime applicable to medical devices. Software specifically intended by the manufacturer to be used for medical purposes, implants and reagents are now included in the concept of "medical devices".
  2. the introduction of the concept of "single-use device";
  3. the manufacturer of the device will be required to include with the medical device an 'implant card' containing information to identify the device, including the name, serial number, lot number, the UDI, the device model and the name, address and website of the manufacturer;
  4. the establishment of a Unique Device Identification (UDI) system, allowing the identification and traceability of all devices placed on the market except for investigational and custom-made devices;
  5. the role of the "responsible person established in the European Union" is replaced by that of "authorised representative". The "authorised representative" is responsible for ensuring the conformity of the devices placed on the European Union market as well as acting as a contact person established in the Union, the authorised representative is furthermore jointly and severally liable with the manufacturer for defective devices

A European Database on Medical Devices (EUDAMED) is created, allowing, among others, the public to be duly informed about devices placed on the market, about the corresponding certificates issued by notified bodies and about the relevant economic operators; it also allows a unique identification of devices on the internal market to facilitate their traceability; it allows the public to be duly informed about clinical investigations and enables clinical investigation sponsors to fulfil the obligations laid down in the legislation.

The information in the EUDAMED database will be publicly accessible and a "Summary of safety and clinical performance characteristics" for high-risk medical devices will be made available there.

An electronic system on post-market surveillance and monitoring is hereby established, aimed in particular at collecting information relating to serious incident reports and field safety corrective actions, trend reports and exchange of information between competent authorities.

The implementation of the Regulation still requires the drafting and publication of ancillary legislation so that it can be applied harmoniously by all Member States.

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