In-Vitro Diagnostic Medical Device Directive (98/79/EC)
Providing access to the European market
Medical devices for in-vitro diagnosis are only allowed on the European market if they comply with the In-Vitro Diagnostic Medical Device Directive (IVDD 98/79/EC).
DEKRA has been officially designated to implement the conformity assessment of the IVDD for access to the EU market. We are also accredited to grant access to markets in other countries and we can certify your Quality Management System.
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 IVDD Directive, we also provide certification for MDD, 510(k) and ISO 13485.
- 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