Règlement Dispositifs Médicaux (MDR)

Règlement Dispositifs Médicaux (MDR)

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MDR Medical Device Regulation
MDR Medical Device Regulation
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Règlement Dispositifs Médicaux MDR

(Contenu en anglais)

The European Medical Device Regulation (MDR) replaced the MDD and the AIMDD and entered into force on 25 May 2017 with 26 May 2021 as date of application.

To access legacy devices’ extended timelines, by May 2024 manufacturers must have implemented an MDR compliant QMS and have applied to a Notified Body for a Conformity Assessment. By September 2024, the Notified Body and the manufacturer must have signed a formal written agreement. Depending on legacy devices classification, MDR transition deadline is May 2026 for Class III custom-made implantable devices, December 2027 for Class III and Class IIb implantable devices (non-WET) and December 2028 for other Class IIb, Class IIa, Class Is and class Im devices. On the same date, up-classified legacy devices (whose Declaration of Conformity was signed by 26 May 2021) now requiring Notified Body involvement must be MDR certified. All legacy devices must be MDR compliant by the end of December 2028.

The sell-off period for medical devices already placed on the market under MDD and AIMDD has been removed. These devices can be made further available on the market without legal time restrictions.

For detailed information and conditions of applicability of transitional provisions, please refer to the Regulation amending (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices published in March 2023.

MDR transition FAQ


Soumission de la documentation MDR

Téléchargez notre guide des meilleures pratiques MDR pour vous aider à préparer et à structurer votre documentation technique lors de la planification de votre demande d'évaluation de conformité MDR auprès de BSI.


Routes de conformité MDR

Notre brochure vous aidera à comprendre les routes d'évaluation de la conformité et à choisir la plus appropriée pour votre dispositif médical.

Formation des dispositifs médicaux

Des Formations

Nous offrons une formation adaptée au règlement sur les dispositifs médicaux pour vous aider à soutenir et à développer votre entreprise.