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.