All medical devices must be certified in accordance with strict regulations. In Europe, compliance with these regulations is evidenced by the issue of the medical CE mark which guarantees that the medical device meets the safety and clinical benefit requirements laid down.

Important dates to remember:

• Since May 2021, medical devices are subject to a new EU regulation 2017/745 (MDR: Medical Device Regulation).
• By 26 May 2024, all medical devices must be marked CE MDR or have obtained an extension of their certificate following the implementation of an MDR approach by submitting an assessment request to a notified body.

In France, the quality and safety (materiovigilance, control, inspection) of all medical devices placed on the market are also monitored by the Agence nationale de sécurité du médicament et des produits de santé (ANSM).