CE Certification Strategy - Expanding the validity of certificate

Thulasidharan

Starting to get Involved
#1
Hi All,

Our organization`s CE certificate getting expiry by December, 2020. Now what is the safer side of expanding the validity of certificate? By using again MDD re-certification audit or MDR complete transition and then audit? Also MDR till date no detailed guidelines will be available. Also still EUDAMED database not available for UDI registration. Kindly guide me the safer side way for validity of certification.

Also like EUDAMED is there any other things still pending from EU?

Thanks in advance.
 
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chris1price

Trusted Information Resource
#2
I would ask your notified body for advice. It may be best for them to do the recertification audit with the new scope now. However getting a slot with them may be difficult.

Yes, there are many, many things still pending from EU. Too many to list :(
 
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