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Any medical device, accessory, non-medical product (Annex XVI) or in vitro diagnostic medical device must comply with the requirements of European Regulations (EU) 2017/745 or (EU) 2017/746 in order to be placed on the market in the European Union. The intervention of a notified body is required for certain devices, depending on their risk class, in accordance with Annex VII of the aforementioned Regulations.
This service is offered by our subsidiary GMED 
GMED (CE 0459), a subsidiary of LNE and a notified body designated by ANSM, carries out conformity assessment activities under these regulations.
Presentation of the certification
Manufacturers can lodge a formal application to GMED to obtain certification following audit of quality management systems, EU type assessment or product verification.
The conformity assessment procedure depends on the risk class of the devices intended to be placed on the market. GMED's scope of designation is available on the European Commission's website via the NANDO information system.
On its website and in a guide, GMED describes its certification process, from pre-application activities to decision-making and, where appropriate, the issuance of the EU certificate(s) of conformity.
Obtaining certification
Begin your application to obtain certification within the scope of the CE marking program by completing the form on GMED website:
