Essentials of European Medical Device Regulatory Affairs

Typical Gaps in CERs

• Does not cover all device variants • Intended users are not clear (if layperson, is information in IFU adequate) • Does not cover the entire target population • Not all claims in marketing brochures have been specified and addressed • Justifications are not documented • Medical alternatives • Unfavourable data NOT included • Disclosure of complete data from Europe and other countries • Equivalency not fully demonstrated • Lack of declaration of interests of each of the evaluators and/or these not up-to-date or not signed by evaluator and the manufacturer

The Organisationfor Professionals inRegulatory Affairs

Equivalence

The Organisationfor Professionals inRegulatory Affairs