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’re 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. Consider these advantages:
- Global presence
- All testing and certificates provided by a single organization. In addition to the IVDD Directive we also provide certification for MDD and ISO 13485
- Were 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’re experts in drug/device combinations and products containing animal material
- If you’re dissatisfied with the service you receive from your current Notified Body, we have experience of assuming certificates.