Can the CER evaluator under EU MDR be an internal employee, and how to manage conflicts of interest?

Question

Is it acceptable for the Clinical Evaluation Report (CER) evaluator under the EU MDR to be an internal person employed by the manufacturer? If so, what steps should be taken to address conflicts of interest and ensure a non-biased review, especially when a declaration of interest is made?

Dr. Oliver Eidel · Accepted Answer

According to MEDDEV 2.7/1 revision 4, the clinical evaluators should provide a declaration of interest. The impartiality and potential for conflict of interest of an external expert reviewer are assessed and documented by the notified body, not the manufacturer. The guidance does not require that the evaluator is completely 'free of interest,' but transparency through a declaration is necessary. If a conflict is identified, it's generally the notified body's responsibility to assess whether it impacts the evaluation's objectivity.

Answer

It is quite common for manufacturers to use internal people as CER evaluators. The key point is to declare any interests or potential conflicts, as transparency is important. How the conflict is managed can vary, but it's not unusual for manufacturers to handle this internally.

Answer

From what our QMS auditor told us, it's most important that you declare any conflicts of interest for transparency. It is not always possible to avoid all conflicts, especially with internal evaluators, but making them visible is key.

Answer

Yes, it's the norm to use internal evaluators in many companies. Conflict of interest can be managed, mainly by declaring it, but ultimately it's up to the notified body to review the situation if there are concerns.

Can the CER evaluator under EU MDR be an internal employee, and how to manage conflicts of interest?

4 Answers

Related resources

Authorised Representative For Non-EU Manufacturers

MDCG 2020-13: Clinical evaluation assessment report template (CEAR)

SGS (Finland)