Transition to MDR (EU 2017/745) - I'd like to make an offer

Ronen E

Problem Solver
Staff member
Moderator
#1
Hello all,

I'm interested in getting myself more up to speed with the new EU MDR.

As many of you have done, I've carefully read it and made lots of highlights and notes :tg: But I know from experience that nothing is better than getting to know a regulation through practice, and the more diverse the better.

Now, my impression is that most small- and micro-manufacturers (my natural habitat ;)) are in denial or maybe think that they have lots of time, while they perceive the move to MDR as resource-hungry (I must admit that this notion is not completely unfounded!...). So I don't (yet?) get a lot of requests for help in that regard. I think bigger businesses have already mobilized, but they either "go it alone" with their in-house staff or have pockets deep enough to bring in heavy artillery, i.e. hire a fancy, large regulatory consultancy firm that pretty much does everything for them.

With that background in mind I'd like to make an offer. I'm willing to engage with manufacturers, free of any charge, to look into an MDR gap analysis* or otherwise support them towards transitioning to MDR. The extent / duration of my involvement can be discussed, keeping in mind that the goal is mutual benefit. I'm looking to gain more MDR experience and insight for a diverse range of device types, manufacturing processes and setups, novelty and risk levels etc. There will be no strings attached (unless you choose to tie them).

*) In this context, by gap analysis I mean examining the manufacturer's current regulatory situation and determining - in detail - what they need to do, and how, to get into compliance with the MDR. A "gap analysis" simply comparing the MDD's (old) text with the MDR's is of less interest I think, and of less practical benefit in any given specific context (a crude correlation between the MDD and MDR clauses can be found in the MDR's Annex XVII).

Please feel very welcome to PM me for any clarification or interest.

Thanks,
Ronen.
 
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EthanLoh

Involved In Discussions
#5
That will depend on your QMS scope.

If you do not performed design and development, then you do not need a full quality management system.

You can exclude clause 7.3 design and development in your QMS.
 

Wolf.K

Involved In Discussions
#6
You can exclude clause 7.3 design and development in your QMS.
You can exclude in 13485 QMS, but in MDR QM requirements?? I heard, that quality manager can be very sure about never having any trouble with not finding a job, but that many many German class 1 manufacturers will get into trouble to fulfill new MDR requirements.
 

EthanLoh

Involved In Discussions
#7
If you are a class I self-declared medical device manufacturer, it will be business as usual. However, your DoC will need to be revised.
E.g. In the new MDR, QMS + self-declared DoC based on Annex II & III

For an existing class I self-declared manufacturer, the new MDR have very little impact on them.

Companies who have class IIb or III implant devices will have a lot of PMS and PMCF to perform. They will be the one to feel the heat. :notme:
 

dgrainger

Trusted Information Resource
#8
Hi,
You need to look at Article 10 - General obligations of manufacturers.
Clause 9 states:
"...Manufacturers of devices, other than investigational devices, shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and in a manner that is proportionate to the risk class and the type of device..."

It then lists the minimum requirements.
 

Marcelo

Inactive Registered Visitor
#9
You can exclude clause 7.3 design and development in your QMS.
Only if the applicable regulatory requirements allow it. On the previous version, only Module D (annex V) permitted this exclusion.

The current EN edition does not seem to have these options (I don't have a full copy of the EN version), so I would say that this exclusion is not allowed.
 
#10
Hello all,

I'm interested in getting myself more up to speed with the new EU MDR.

As many of you have done, I've carefully read it and made lots of highlights and notes :tg: But I know from experience that nothing is better than getting to know a regulation through practice, and the more diverse the better.

Now, my impression is that most small- and micro-manufacturers (my natural habitat ;)) are in denial or maybe think that they have lots of time, while they perceive the move to MDR as resource-hungry (I must admit that this notion is not completely unfounded!...). So I don't (yet?) get a lot of requests for help in that regard. I think bigger businesses have already mobilized, but they either "go it alone" with their in-house staff or have pockets deep enough to bring in heavy artillery, i.e. hire a fancy, large regulatory consultancy firm that pretty much does everything for them.

With that background in mind I'd like to make an offer. I'm willing to engage with manufacturers, free of any charge, to look into an MDR gap analysis* or otherwise support them towards transitioning to MDR. The extent / duration of my involvement can be discussed, keeping in mind that the goal is mutual benefit. I'm looking to gain more MDR experience and insight for a diverse range of device types, manufacturing processes and setups, novelty and risk levels etc. There will be no strings attached (unless you choose to tie them).

*) In this context, by gap analysis I mean examining the manufacturer's current regulatory situation and determining - in detail - what they need to do, and how, to get into compliance with the MDR. A "gap analysis" simply comparing the MDD's (old) text with the MDR's is of less interest I think, and of less practical benefit in any given specific context (a crude correlation between the MDD and MDR clauses can be found in the MDR's Annex XVII).

Please feel very welcome to PM me for any clarification or interest.

Thanks,
Ronen.
Hello Ronen,

We are a medical barrier clothing supplier. we have never implemented MDD earlier. I need your help as we are very new. I believe we fall in class 1 but not sure which annex. Could you advise me appropriate annex. also, do you have any checklist of essential requirement and any template for Quality management system ?

Regards
Sandy
 
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