MDD CM, MDR manufacturer. 2020. Is it ok?

#1
Hello!

Just confused and can't find proper answer by myself into MDR document.

quotation from the MDR:

"Article 120 Transitional provisions
Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC from 25 May 2017 shall remain valid until the end of the period indicated on the certificate, which shall not exceed five years from its issuance. They shall however become void at the latest on 27 May 2024."


Question: If Legal manufacturer prepares MD technical file under MDR rules, but his Contract manufacturer has approved manufacturing processes under MDD and still have valid MDD valid certificate.
Regarding quotation: Is it OK to run production of MD with such manufacturer? (Legally, with no conflict of regulations)

Thanks
 
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shimonv

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#2
There is only one legal manufacture for a device, and that can be based on MDD or MDR.
It is sufficient for your contract manufacture to comply with ISO 13485, and even that is voluntary.
 
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