CE marking for medical devices

What is CE marking ?

In order to guarantee user safety, most of the consumer goods marketed in the EU must have CE marking, , excluding food products. It ensures that a product meets the general safety and performance requirements and gives it the right to be freely traded in the European Union.

Regulation (CE) n° 765-2008 of 9th july 2008, establish the general principles of CE marking.

Depending on its type and classification, a product may be subject to one or more European regulations.

How to obtain CE marking ?

It is the manufacturer's responsibility to comply with these requirements and to take the necessary steps to obtain the CE marking, like : compile technical documentation presenting the evidence needed to demonstrate the quality and safety of the device (source : ANSM)

For medical device project sponsors, the regulations to follow are the new European regulation 2017/745 (MDR) or 2017/746 (IVDR - In Vitro Diagnostic Medical Device). This involves:

• Implementation of an ISO 13485 compliant Quality Management System (QMS) within the company initiating the project ;
• Drawing up Technical Documentation in compliance with applicable European regulations to manage product risks ;
• The selection of a clinical evaluation pathway to attest to the performance, safety and clinical benefit of the device regarding the human variability.

To carry out all these steps, the manufacturer can seek support from a specialist quality, regulatory and clinical affairs organization with expertise in the two European regulations and applicable standards such as ISO13485, ISO14155; ISO 14971 and IEC62304.

Depending on the class of medical device, the CE mark is delivered by a notified body.
Before this an application for certification must be submitted.