Transitioning to the EU MDR

Philip B

Involved In Discussions
#1
How much of the QMS and technical documentation can be upgraded to MDR requirements now, prior to the implementation date and prior to a conformity assessment? For example, could we replace our essential requirements checklist with general safety and performance requirements now, on the basis that although the MDR is not in force, it does represent state of the art and the requirements are in excess of the MDD? Or does everything have to be created in draft until we transition? Interested in opinions...thanks
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
The MDR is already in force and you may (actually, better) voluntarily upgrade now rather than wait for the last minute.
 
#3
The MDR is already in force and you may (actually, better) voluntarily upgrade now rather than wait for the last minute.
Well, actually, if his devices are certified under the MDD he still has 4 years to comply to the MDR (depending on the date on the certificate).
Until then, only the requirements regarding vigilance, post-market surveillance, and registration of economic operator have to be fulfilled in order to be compliant with the MDR
 

Asia78

Involved In Discussions
#4
How much of the QMS and technical documentation can be upgraded to MDR requirements now, prior to the implementation date and prior to a conformity assessment? For example, could we replace our essential requirements checklist with general safety and performance requirements now, on the basis that although the MDR is not in force, it does represent state of the art and the requirements are in excess of the MDD? Or does everything have to be created in draft until we transition? Interested in opinions...thanks
You should do it as soon as possible and ask your notified body to be certified also as soon as possible: they will audit to see you implemented the Mdr requirements in your qms.
If you have not done it yet, you are very late...sorry to say it.
You can use the GSPR for your devices only when you are MDR certified, so you will need to keep in parallelel some mdd and some Mdr (for audit purposes) documents.
 

Watchcat

Trusted Information Resource
#5
If you are asking us instead of an NB, that's probably not a good sign. (That is sort of a joke.)

As other responses reflect, you could probably get a more helpful feedback if you provided a little more information about the status of your devices with respect to the MDD/MDR, as well as your NB situation. When do you expect to transition your device(s)? By May 2020? Do you have an NB to support your MDD certification? Do you have one to support MDR certification? Same or different NB?
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Well, actually, if his devices are certified under the MDD he still has 4 years to comply to the MDR (depending on the date on the certificate).
Until then, only the requirements regarding vigilance, post-market surveillance, and registration of economic operator have to be fulfilled in order to be compliant with the MDR
That's why I used the words "may", "better" and "voluntarily", rather than "must" and the likes.
Please note that the OP asked whether, when etc. "they can...", not "they have to..." or even "they should...".
I'm of the opinion that everything in the MDR (including the GSPR, @Asia78) can be used even if you're still going by / certified to the MDD, because in 99% of the cases (if not 100%) the MDR is more onerous and the MDD requirements will be a a subset anyway.
 

Philip B

Involved In Discussions
#7
Thanks all. To clarify, we are currently under the MDD and are covered until 2022. We have submitted our application to transition to the MDR with our NB and we are on target to transition in June 2020. I'm currently upgrading our QMS and technical documentation in preparation for the transition hence my question. I tend to agree with Ronen that most things can be upgraded now as they will be above and beyond MDD requirements.
 

Asia78

Involved In Discussions
#8
I agree that all what you do for MDR could be used for mdd. I think it is more the point if you want to use them all...
Example Essential requirements and general safety and performance requirements. The GSPR are much more complex and require more time to be completed. So you really want to do it for all your mdd devices which may stay as such for potentially 4 more years?
It depends on how many mdd devices you have of course and on how much you change them
In my company there is a race between different department on developing new features and planning released before may 2020. If I start asking to follow GSPR they will probably start shooting at me
 

Ronen E

Problem Solver
Staff member
Moderator
#9
I agree that all what you do for MDR could be used for mdd. I think it is more the point if you want to use them all...
Example Essential requirements and general safety and performance requirements. The GSPR are much more complex and require more time to be completed. So you really want to do it for all your mdd devices which may stay as such for potentially 4 more years?
It depends on how many mdd devices you have of course and on how much you change them
In my company there is a race between different department on developing new features and planning released before may 2020. If I start asking to follow GSPR they will probably start shooting at me
Where there's a choice, I agree that each manufacturer should carefully consider whether to apply MDR provisions, on a case by case basis.
I only intended to reply to @Philip B that (IMO) there's nothing stopping them from implementing the MDR right away, if they choose to.
 
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