New EU Medical Device Regulation & Reconciling with EN ISO 14971

blah01

Involved In Discussions
Does anyone know when the new MDR will take effect?

Also, given that it seems to align more with the ISO 14971 standard, does anyone know if/when the EN ISO 14971 will be revised to hopefully repeal, as applicable, the 7 deviations?

Thanks.
 

Ronen E

Problem Solver
Moderator
the regulations are expected to enter into force in either May or June 2017, with the new rules becoming applicable in 2020 for devices and 2022 for IVDs.

https://www.raps.org/Regulatory-Foc...usly-Adopts-MDR-IVDR-Next-Stop-EU-Parliament/

After much discussion, it was decided late last year that the international standard ISO 14971:2007 would be revised. It is expected that the revised international standard will be adopted as a European Standard and that the requirements of the imminent Medical Devices Regulations will be considered. The Working Group is holding its first face to face meeting to start on the revision in February

https://www.bsigroup.com/en-GB/blog...ement-standard-ISO-14971-for-medical-devices/

For a status update (Feb 16 2017) please see Marcelo Antunes' post.
 
Last edited:

Ronen E

Problem Solver
Moderator
As we were speaking the EU Parliament has given final approval and the MDR is now expected to be officially published in the Official Journal in May and come into force 20 days later.
 

Chrisx

Quite Involved in Discussions
I don't see the new MDR fixing any of the issues with ISO 14971, because it still requires risks be reduced as far as possible. This still poses a fundamental problem that the regulation is unenforceable in this regard. It is an unrealistic regulation as the only way to reduce risks to AFAP, is 100% destructive testing. No sampling plan reduces risk as the confidence interval chosen can always be higher. Clinical enrollments can also always be higher, until the entire population of the planet is enrolled. Sorry, risk management is still broken.
 

Marcelo

Inactive Registered Visitor
I don't see the new MDR fixing any of the issues with ISO 14971, because it still requires risks be reduced as far as possible. This still poses a fundamental problem that the regulation is unenforceable in this regard. It is an unrealistic regulation as the only way to reduce risks to AFAP, is 100% destructive testing. No sampling plan reduces risk as the confidence interval chosen can always be higher. Clinical enrollments can also always be higher, until the entire population of the planet is enrolled. Sorry, risk management is still broken.

Hum, curious comment. The Eu task force of the ISO JWG 1 Wg concluded the the new text solved most of the problems, but you pointed out one real problem that still exists (although in my opinion is has nothing to do with inspection or testing).

There seems to be a solution for the "as far as possible" problem when the text says that "The requirement in this Annex to reduce risks as far as possible means the reduction of risks as far as possible without adversely affecting the benefit-risk ratio". But I will have to think more about that.

I remembered this post because I'm drafting some suggested text for the revision of ISO 14971 and this problem appeared again. We do really have to deal with that in a final way otherwise it will always come back. Thanks for the comment.
 

Ronen E

Problem Solver
Moderator
"The requirement in this Annex to reduce risks as far as possible means the reduction of risks as far as possible without adversely affecting the benefit-risk ratio" (from the MDR) sounds to me like a way of saying we're back to ALARP or that there is room for economical considerations (in contrast with the magnificent 7 deviations but totally in line with the MDD's spirit as explicitly expressed in its preamble), without down right admitting that the AFAP concept was a ridiculous slip to begin with.
 

Marcelo

Inactive Registered Visitor
"The requirement in this Annex to reduce risks as far as possible means the reduction of risks as far as possible without adversely affecting the benefit-risk ratio" (from the MDR) sounds to me like a way of saying we're back to ALARP or that there is room for economical considerations (in contrast with the magnificent 7 deviations but totally in line with the MDD's spirit as explicitly expressed in its preamble), without down right admitting that the AFAP concept was a ridiculous slip to begin with.

Part of the problem seems to be that several other EU regulations and directives do use the term AFAP, I've checked some and they are the same. I could not trace where this really comes from.
 

Ronen E

Problem Solver
Moderator
Part of the problem seems to be that several other EU regulations and directives do use the term AFAP, I've checked some and they are the same. I could not trace where this really comes from.

(At the risk of going controversial)

Politics?
 

Marcelo

Inactive Registered Visitor
(At the risk of going controversial)

Politics?

Heh :p, I'm pretty sure politics is one, if not THE source, however, I was trying to find the first mention and rationale for this (there's probably something like that somewhere).
 
Top Bottom