We use cookies on our website to personalize content and ads, to provide social media features and to analyze traffic to our website. To provide you with a convenient online experience and to improve our communications, please click "ACCEPT ALL". By doing so, you consent to the processing and sharing of your information with our social media, advertising and analytics partners. You can revoke your consent at any time in the settings.
Data protection declaration | Legal notices
Setting

Active Implantable Medical Device Directive

Manufacturers of active implantable medical devices are only allowed to sell products on the EU market if they comply with the Active Implantable Medical Device Directive (90/385/EEC). DEKRA has been officially designated to review the compliance of products with the requirements of the AIMDD for access to the EU market.

Transition from AIMDD to MDR

The current AIMDD will be replaced by the MDR. This regulation came into force on May 25, 2017, and the transitional period will end in 2020. The regulation covers medical devices among which active implantable medical devices under a single text. The scope of the MDR has been extended to include additional devices.
Contact us