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Dual MDD and MDR certification

Sullen-gent

Starting to get Involved
#1
Presently I work for a company that manufacturers a number of medical devices and the plan is to continue to sell into the EU under the MDD during the transitional period and transfer to the MDR at a later date. As part of the transition rules we cannot make significant design changes to products during the transition.

A question arose could a company make design changes to one instrument in the portfolio, and submit this change under MDR (with revised tech. file) to the NB and keep the remaining products under MDD?

As the devices are Class IIB this would presumably also require the manufacturer to achieve compliance with annex IX and submit the amended MDR tech. file.
Can you hold MDR and MDD certs. at the same time?
Would this vary by Notified body or does this violate a regulation?
 
#2
A question arose could a company make design changes to one instrument in the portfolio, and submit this change under MDR (with revised tech. file) to the NB and keep the remaining products under MDD?
To my knowledge, yes it is possible. I have a client who is working with TUV and they have this understanding that a new product in 2020 will go through the MDR route while the currently approved device will remain under MDD until the transition to MDR is complete.

I see no conflict between MDD and MDR. Also, it seems to me that it is in the best interest of the NB to move forward this way; they don't have sufficient resources to make a drastic 'jump' from MDD to MDR.

Having said all that - you must confirm this with your NB.

Shimon
 

fialor

Involved In Discussions
#3
Sullen-gent, my understanding from my NB is that this is possible but it has to be a different product, meaning you would be looking at new labelling, new product codes etc. And this is because the same code cannot be approved under the two regulations; once compliance with MDR is claimed for a code, the MDD needs to be dropped. One cannot get around the same code rule (I know - new labelling and packaging nightmare!) by using two separate NBs as this is not allowed either.
I hope it helps.

Presently I work for a company that manufacturers a number of medical devices and the plan is to continue to sell into the EU under the MDD during the transitional period and transfer to the MDR at a later date. As part of the transition rules we cannot make significant design changes to products during the transition.

A question arose could a company make design changes to one instrument in the portfolio, and submit this change under MDR (with revised tech. file) to the NB and keep the remaining products under MDD?

As the devices are Class IIB this would presumably also require the manufacturer to achieve compliance with annex IX and submit the amended MDR tech. file.
Can you hold MDR and MDD certs. at the same time?
Would this vary by Notified body or does this violate a regulation?
 
#4
Can you hold MDR and MDD certs. at the same time?
Would this vary by Notified body or does this violate a regulation?
Yes. This is a strategic option that some manufacturers are pursuing right now.

No (Although NBs might have different opinion, they should not, as this is very clear in the regulation).
 

Sullen-gent

Starting to get Involved
#5
All great feedback

Yes. This is a strategic option that some manufacturers are pursuing right now.

No (Although NBs might have different opinion, they should not, as this is very clear in the regulation).
When you say it's very clear in the regulation is there a specific article that states it is acceptable, or do you mean there is nothing to state this can't be done?

I thought it might depend on the NB but that practicalities would force the issue as there is difficulty for a manufacturer to get 100+ devices ready for MDR simultaneously, and that a phased approach would work well i.e. submit new devices for MDR, get feedback, then go for legacy devices later.
 
#6
All great feedback

When you say it's very clear in the regulation is there a specific article that states it is acceptable, or do you mean there is nothing to state this can't be done?

I thought it might depend on the NB but that practicalities would force the issue as there is difficulty for a manufacturer to get 100+ devices ready for MDR simultaneously, and that a phased approach would work well i.e. submit new devices for MDR, get feedback, then go for legacy devices later.
Well, in fact it may not be totallyyyyyyy clear on the regulation (although it's a little obvious if you read article 120 item 6 and notes that nothing saying to the contrary), but it is clear on question 11 of the CAMD Transition Sub Group - FAQ – MDR Transitional provisions.
 

snowball852

Starting to get Involved
#7
There is a FAQ put out by the CAMD (attached) that clearly states that you can have an MDD certificate and an MDR certificate in parallel (Question 11). However, what it does not state is whether that can be for the same product or not. I have asked this question also on the RAPS Online exchange and the sentiment there is that you cannot have two valid certificates for the same product - once you receive your MDR certificate, it will supersede the MDD certificate. One commentor wrote that their NB (SGS) clearly stated this to them. So, best to clarify with your NB....
 

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