Qualification of Evaluator - Clinical Evaluation Report MEDDEV 2.7.1 Rev 04

#1
We are a company in Turkey with all QA system managed in Turkish. Our ISO 13485 and CE mark are registered by a Turkish NB. Based on their interpretation of clause 6.4 of MEDDEV 2.7.1 Rev 04, our NB insists that the evaluator must be a "medical doctor" per definition of "specialist" on dictionary for Medical English. More of it, they say the Ministry of Health urges them to make this adaptation.

I tried to reason with them by explaining/translating the clause: when it states "e.g.
specialist clinical expertise in the relevant medical specialty", it means a clinician is a possible person, not a requisite.

Please correct me if I am wrong or help me convince them if I am correct.
Many thanks!
 
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Mark Meer

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#3
In my opinion, you are correct.

First, MEDDEV documents are intended as guidance, and so the NB shouldn't be citing you non-conformances based on MEDDEV contents. It is the regulations (or Directive) that is the authoritative requirements.

With regards to clinical evaluations, I'm not aware of anything in either the old Directive (MDD 93/42/EEC), or new regulation (EU 2017/745) that calls for persons doing clinical evaluation reports to have specific qualifications. That being said, there should be some documentation of their qualification within the context of your quality system.

Clinical investigations, on the other hand, are different... For example, the MDD 93/42/EEC states: "The investigations must be performed under the responsibility of a medical practitioner or another authorized qualified person in an appropriate environment." (Annex X, 2.3.6). ...but even then, to interpret this as it must be a "medical doctor" is a bit of a stretch...
 

FoGia

Involved In Discussions
#4
I share the opinion that the guidance is not an authoritative requirement but I have the interpretation that it sets a level of expectation for the competent authorities/notified bodies on which they can base their evaluation of the clinical evaluation.

Even the MEDDEV doesn't call for a medical doctor, but it says that you must have in your team of clinical evaluators someone with sufficient clinical expertise. Depending on the type of medical device and its intended purpose I would imagine that a notified body would be in their right to impose the participation of a doctor during a clinical evaluation.
 
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