IVDR assessment by a notified body
Certification of in vitro diagnostic devices
Are you planning to place an in vitro diagnostic medical device on the market in the European Union (EU)? Then CE-marking demonstrating compliance with the In Vitro Diagnostic Regulation (IVDR) 2017/746 is required. You often need a notified body to assess whether your products comply. As a notified body, DEKRA Certification B.V. can assess whether your product complies with IVDR.
What is CE certification?
What is a notified body?
When do you need to use a notified body to obtain CE IVDR certification?
What are the next steps for an IVDR assessment?
- an off-site review of the technical dossier(s);
- an on-site Quality Management System (QMS) audit.