New Product Model CE Mark Certification under MDR

Vicky Santos

Starting to get Involved

I would like to get some advise regarding the conformity assessment and CE certification of new product models to be added to a group of CE marked medical device family and already existing in the market.
The CE marked medical device family is a Class IIb, non active implantable device, composed of 5 product models. We are planning to add 2 or more product models, using exactly same material, the same manufacturing process but different design (a slight difference in physical dimension). Can I apply the demonstration of equivalence based on the data of medical device family already in the market, for the purpose of CE-marking certification under the MDR?.

Can you share some of your thoughts and useful references that I can follow to help me guide in applying altogether the group of medical device family, including the new product models, for CE certification under MDR?

Thank you so much for your help.
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