Active Implantable Medical Device Directive (90/385/EEC)
Manufacturers of active medical devices intended to remain permanently in the body are only allowed to sell products in the European market if they comply with this directive.
DEKRA has been officially designated to review the compliance of products with the requirements of the AIMDD for access to the European market. We are also accredited to grant access to markets in other countries. Moreover, you can call on us for certification of your Quality Management System according to ISO 13485 and Directive 2007/70/EC, which became mandatory for medical device manufacturers in March 2010.
DEKRA is a full-service provider for medical device manufacturers.
- Global presence
- All testing and certificates provided by a single organisation. In addition to the AIMD Directive, you can also call on us for IEC 601 tests, 510(k) reviews and ISO 13485 certification.
- We are specialists with extensive experience in the medical industry
- You have one permanent contact throughout the process
- We participate in all MRAs (USA, Japan, Taiwan and Australia)
- We are experts in drug/device combinations and products containing animal material
- We have developed a special programme that helps you into market
- If you are dissatisfied with the service you receive from your current Notified Body, we have experience in assuming certificates