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Medical Device Directive - Annex VI assessment
I´m glad
to find a place where i could exchange ideas and doubts about CE marking of medical devices.
I read the MDD 93/42/EEC, the ISO 13485 and I have asked a notified body. but I still have many doubts.
the case is the following:
- medical device class IIa
- contract manufacturer with ISO 9002 or ISO 13485
- we have not a QMS certified
- we have been recommended to follow Annex V or VI of the MDD.
our doubts are:
1) if our contract manufacturer, who gives us the final product, has ISO 9002 or ISO 13485, should we certified ISO 13485 for any of our company´s activities (testing and final verification, dispatch, complain, etc)? because we read that it´s not compulsory but the notified body opinion is the opposite.
2) should the contract manufacturer´s suppliers have ISO 9002 or 13485?
3) and in the case we want to sell a product which has been manufactured under ISO 9002 or ISO 13485, but which has no CE mark. what should we ask for to the manufacturer? as importers, should we certify our activities?
I would be very pleased if someone could help me!!!

I´m glad
to find a place where i could exchange ideas and doubts about CE marking of medical devices.
I read the MDD 93/42/EEC, the ISO 13485 and I have asked a notified body. but I still have many doubts.
the case is the following:
- medical device class IIa
- contract manufacturer with ISO 9002 or ISO 13485
- we have not a QMS certified
- we have been recommended to follow Annex V or VI of the MDD.
our doubts are:
1) if our contract manufacturer, who gives us the final product, has ISO 9002 or ISO 13485, should we certified ISO 13485 for any of our company´s activities (testing and final verification, dispatch, complain, etc)? because we read that it´s not compulsory but the notified body opinion is the opposite.
2) should the contract manufacturer´s suppliers have ISO 9002 or 13485?
3) and in the case we want to sell a product which has been manufactured under ISO 9002 or ISO 13485, but which has no CE mark. what should we ask for to the manufacturer? as importers, should we certify our activities?
I would be very pleased if someone could help me!!!

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