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.
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
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.
"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.
(At the risk of going controversial)
Politics?