MDD Certification Validity after May 2020

Watchcat

Trusted Information Resource
#11
Yes, they might not see the point in replying until they know if they are going to be MDR designated. And they may be so overloaded with clients who need MDD renewals prior to May 2020, they don't have the resources.

Another possibility is that they don't want you as a client under the MDR. There are going to be too few NBs and too many potential clients for some time to come. Under these circumstances, most NBs are going choose large clients over small ones.
 
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Marcelo

Inactive Registered Visitor
#12
Ups¡ yes, the situation is complicated.
I want to start the transition of our CE certificate under MDD to MDR, but I supose that the NB can't reply until getting its acreditation.
They can't reply before they are designated because the rules prevent them performing any "pre-certification" services before a manufacturer lodges an application with them (which would required that they are designated). This has always been the case, but for the MDR, it's been enforced by the CAs and the NBs are then afraid of being punished by bad behavior.

You can see an examples of this on the MCDG document on NBs:

I.6. May CAB provide pre-certification services?
Pre-certification services are not allowed before an application is lodged by the manufacturer (e.g. review of clinical data or assessment of the quality management system aside from regulatory standards such as ISO 13485) and therefore these services have to take place under the scope of the application.

...

Services provided by the CAB that could fall under the definition of conformity assessment activities are not allowed outside of an application as they would be regarded as consultancy (e.g. gap analysis, check of MDR/IVDR readiness, use of mock-up files produced instead of “real” TD assessments).
 

Watchcat

Trusted Information Resource
#13
They can't reply before they are designated
But if they are designated under the MDD, and the inquiry is about whether or not it will be possible to renew that certificate prior to May 18 2020, it seems to me that they should be allowed to address that question, and also to do the renewal, whether they become designated under the MDR or not.

I'm also inclined to doubt that they are prohibited from requiring "Thank you for your inquiry. We have applied for MDR designation but have not yet received notice of designation. Until we receive such notice, we are prohibited from discussing our MDR services with you. As soon as we receive such notification, we will be happy to discuss our services with you." I'm more inclined to think overloaded NBs have overinterpreted this prohibition as a justification for not replying.
 
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