Quick due dilligence checklist for non-integral DDC

Pharmaceutical companies that want to place a non-integral drug-device combination on the EU market need to work together with a medical device manufacturer. The device must be CE-certified for the right intended purpose before the market authorization application can be filed. Therefore, it is important for the drug company to keep sufficient control over the medical device conformity assessment procedure. The checklist can provide an indication of the progress of this certification process.

Application form

Company data
PRRC data
PRRC role
PRRC specific topics
Optional mailing list
Do you want your name and email address to be share with the other participants in the training? If you agree you will be added to a group mailing list, if you don’t agree or you don’t indicate anything, you will receive the same messages individually.
Optional coaching
For PRRCs that want additional personal training, there is the option of booking this together with your training. For most PRRCs 2-5 hours will be adequate.
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