CE Marking for Medical Devices under European Regulation 745/2017 (MDR)
 

Regulation on CE Marking of Medical Devices (MDR) and its scope

To be placed on the European market, medical devices (MD) must comply with the specific requirements of Regulation 745/2017 (MDR), which entirely replaced Directive 93/42/EEC as amended as of 25 May 2021.
The European Regulation 745/2017 applies not only to medical devices but also to products without a medical purpose, listed in Annex XVI, and covers Clinical Investigations relating to Medical Devices (MD).

What is new in Regulation 745/2017 (MDR)?

The key changes introduced by the new Regulation include:

• New and/or more detailed technical product requirements;
• Special classification rules for certain types of MDs such as software and substance-based devices;
• Specific obligations not only for manufacturers but also for agents, importers, and distributors, as well as ad hoc requirements for the Quality Management System.

What is the purpose of CE marking for medical devices?

To access the European Union market, medical devices must obtain CE marking in accordance with Regulation 745/2017. This Regulation governs the process of placing medical devices and related accessories on the market, their commercialization, and their use for human purposes. It also applies to non-medical devices listed in Annex XVI.

Bureau Veritas Medical Device Certification

Bureau Veritas is a Notified Body (no. 1370) for the performance of certification services required for CE Marking of medical devices and accessories. It is now designated by the European Commission to operate under Regulation 745/2017 for both non-medical and medical devices, covering all risk classes (Ir, Is, Im, IIa, IIb and III).

The main steps of the certification process include:
1.    Evaluation of the technical file prepared by the Manufacturer according to the content index required by the Regulation;
2.    Certification audit for issuing the CE marking certificate;
3.    Scheduled and unscheduled surveillance audits to verify the maintenance of the applicable requirements.

The certificate is valid for 5 years, unless the Manufacturer fails to comply with one or more applicable requirements. Certification renewal follows the same process outlined above.

Bureau Veritas has established a dedicated development line for the healthcare sector within its matrix structure, boasting specific expertise and in-depth knowledge and experience. This makes Bureau Veritas an exclusive partner for CE marking and ISO certification services, providing clients with the experience of an International Group with a widespread presence in 140 countries.

Would you like to download the instructions for filling in the information questionnaire preparatory to obtaining certification? Fill il the form

FAQ - Frequently Asked Questions about Regulation 745/2017