MDR harmonized standards

mf389

Starting to get Involved
#1
BSI lists the newer version of 14971 as "EN ISO 14971:2019", Does this mean it is harmonized in the EU? Is this to the MDD or the MDR? Are they going to release a list of harmonized standards for the MDR as they currently have for the MDD?



Thoughts?
 
Elsmar Forum Sponsor
#4
Greenlight Guru recently had a webinar on ISO 14971 and MDR (by Peter Sebelius).

I cannot post links (yet) but if you google iso 14971 mdr this webinar should show up.

I was rather chocked when I listened to this webinar. It turns out that the attempt they did to harmonize ISO 14971:2019 with the MDR failed!!

Peter said in the webinar that there will be a meeting this spring, and hopefully a sensible/pragmatic solution can be found.

If this is news to you, and if you develop medical devices for the EU market, I strongly recommend listening in to Peter's excellent presentation on ISO 14971 and MDR.

Until more information is available, my preliminary conclusion is that we will keep adhere to ISO 14971:2019, and hope for the best, after all it is "state of the art". Hopefully this will be sorted out.

What do other people think about this?
 

Watchcat

Trusted Information Resource
#5
I was rather shocked when I listened to this webinar. It turns out that the attempt they did to harmonize ISO 14971:2019 with the MDR failed!!
It's sort of an ongoing joke with me and colleagues, "Some day I really *must* read ISO 14971." I've tried a few times, got bored due to the lack of perceived relevance to analyzing clinical risk, at least from an FDA perspective. Now I think maybe from an MDR perspective too.

I know I'm not the only device RA professional that thinks ISO should stick to technical standards and stay away from topics like QMS and risk management, at least as they apply to regulated products. ISO is not a regulator, and that actually does matter. So I guess I'm not only not shocked, but slightly buoyed by the news. Would be interested to know what failed to align.

As for ISO 14971:2019, it might well be "state of the art," but what art, exactly? I'm inclined to think, not the art of regulating medical devices.
 
#6
It's sort of an ongoing joke with me and colleagues, "Some day I really *must* read ISO 14971." I've tried a few times, got bored due to the lack of perceived relevance to analyzing clinical risk, at least from an FDA perspective. Now I think maybe from an MDR perspective too.

I know I'm not the only device RA professional that thinks ISO should stick to technical standards and stay away from topics like QMS and risk management, at least as they apply to regulated products. ISO is not a regulator, and that actually does matter. So I guess I'm not only not shocked, but slightly buoyed by the news. Would be interested to know what failed to align.

As for ISO 14971:2019, it might well be "state of the art," but what art, exactly? I'm inclined to think, not the art of regulating medical devices.
Hello,

Thanks for your comment. I am still new to the FDA process, and I was wondering if you could share your experiences on risk management from an FDA process perspective?

I noticed that ISO 14971:2019 is listed as a recognized standard in the FDA database.
 

Watchcat

Trusted Information Resource
#7
Another joke, FDA "recognized" means "Oh, yeah, I recognize you. You're the guy who walks the border collie every morning, right?"

To be fair, my information is probably outdated. Maybe someone else here has had more positive experience lately. And I can't say mine is been negative, just that, in the end, FDA always makes up its own mind, as do I. In that sense, we are a good "cultural fit."

I would always follow an FDA recognized standard, if one is available and **I** thought it made sense. I think this works much better with technical standards like 60601 than with things like risk management, design controls, quality management, which I personally don't think lend themselves well to standardization.

I would not expect FDA to accept something that conformed to a standard it recognizes without question. Also, I share the common wisdom that, some standards, like ISO 13485, are "a good start," but are simply not enough for compliance with FDA's QSR.

My work is premarket regulatory clearance. For that, I take whatever clinical risks, harms, whatever that have been identified through whatever risk analysis process the development team has chosen to follow and I pursue them, as I said, from a qualitative, not quantitative perspective. Any clinical harm can manifest itself across a range of severities and with different frequencies in different populations.

I take more of an EU clinical evaluation approach than an ISO 14971 approach. Unless these are the same thing, but it's my impression that they are not. The purpose is to demonstrate safety and effectiveness (sometimes indirectly, through substantial equivalence), not to set up a baseline for risk management. Perhaps it can also serve that purpose. Or not.

I also work almost exclusively with Class III devices, where this all gets a much higher level of scrutiny. For Class I and II, the difference might not matter so much.

Again, others here may be able to offer more recent experience, and also experience more applicable to 510(k) devices, which account for the overwhelming majority of medical devices that go through FDA.
 
#8
Thanks for your perspective. I am still quite new in this field, and appreciate the insights.

I am working on a class II de novo device, so less scrutiny than a class III but I assume more scrutiny than a class II 510(k).
 
Thread starter Similar threads Forum Replies Date
Ed Panek MDR Harmonized Standards Updated EU Medical Device Regulations 1
N Harmonized Standards for MDR Certification EU Medical Device Regulations 7
R Applicability of new non-harmonized standards (MDD/MDR) EU Medical Device Regulations 14
F MDR GSPR 23.4 (c) EU Medical Device Regulations 0
B What are "appropriate drawings" required for a MDR in 21CFR820? ISO 13485:2016 - Medical Device Quality Management Systems 3
M MDR transfer for legacy devices EU Medical Device Regulations 1
Ed Panek Auditor Comment about MDR vs MDD EU Medical Device Regulations 10
N The new MDR requirements - SPR section #10.4 EU Medical Device Regulations 2
T Choosing a Notified Body for MDR - SGS/BSI/DNV/DQS-MED Registrars and Notified Bodies 0
M Reworking MDD product w MDR labeling CE Marking (Conformité Européene) / CB Scheme 5
A MDR and Poland EU Medical Device Regulations 6
Ed Panek Invitation to the MDR Dance EU Medical Device Regulations 5
M EU MDR language-Translation requiremens CE Marking (Conformité Européene) / CB Scheme 8
I What are suitable indicators and threshold values in MDR/IVDR? Medical Device and FDA Regulations and Standards News 5
A Sell-off legacy devices MDR EU Medical Device Regulations 0
A Eudamed actor registrations if you change AR for MDR product EU Medical Device Regulations 0
Ed Panek Which choice of the following most closely matches the MDR compliance of your company? EU Medical Device Regulations 0
K Definition of SAE under MDR EU Medical Device Regulations 3
Q Harmonised Standards (EN ISO 13485 / EN ISO 14971) in MDR (2017/745/EU) ISO 13485:2016 - Medical Device Quality Management Systems 3
Ed Panek Clarity from EC on Importer/Distributor roles in MDR EU Medical Device Regulations 9
Pmarszal BS EN 20417:2021 - Implementation Timeline Aligned With MDR? Other ISO and International Standards and European Regulations 1
T Dental lab acrylics and MDR EU Medical Device Regulations 0
S Biggest issues when producing MDR compliant Technical Files / DD EU Medical Device Regulations 4
A Declaring Conformity with MDR Article 120(3) for an MDD Legacy Device EU Medical Device Regulations 1
D EU MDR - Change of device name (legacy device) EU Medical Device Regulations 17
J Technical Documentation as per MDR / subpoint 6.1 EU Medical Device Regulations 3
M EU MDR - Retrospective Study for expanding indications of a legacy device EU Medical Device Regulations 0
B MDR Technical Structure EU Medical Device Regulations 3
D Notified Bodies - ISO 13485 & MDR Technical Files ISO 13485:2016 - Medical Device Quality Management Systems 3
L Configurable UDI mdr EU Medical Device Regulations 0
O EU MDR labels EU Medical Device Regulations 1
S Summary of safety and clinical performance and Article 120(3) of the MDR EU Medical Device Regulations 4
M MD Class I transition period MDD to MDR - changes? EU Medical Device Regulations 1
C UDI for consumable/replacement components under the MDR EU Medical Device Regulations 2
E Article 17 MDR - (Re-)Processing EU Medical Device Regulations 0
H Article 22 MDR System EU Medical Device Regulations 16
L REACH compliance with MDR EU Medical Device Regulations 4
L EU MDR Ramifications for no expiration date on labeling EU Medical Device Regulations 1
R How to obtain OBL licence under Indian MDR, 2017 Other Medical Device Related Standards 2
F MDR – Article 120 – Transitional provisions EU Medical Device Regulations 8
H MDR Article 13(c) EU Medical Device Regulations 6
Ed Panek Auditor MDR (Presub audit) finding EU Medical Device Regulations 2
M Classification of Instruments under EU MDR EU Medical Device Regulations 1
M Procedure for vigilance system according to new MDR EU Medical Device Regulations 0
M Procedure for clinical evaluation according to new MDR EU Medical Device Regulations 11
R MEDDEV 2.12-1 rev 8 (Vigilance guidelines) still applicable with the MDR implementation? EU Medical Device Regulations 1
S Determining a device category according to the MDR EU Medical Device Regulations 3
A Transactions under MDR Medical Device and FDA Regulations and Standards News 3
H Has anyone undergone MDR FQA review yet? EU Medical Device Regulations 10
S UK MDR + EU MDR Declaration of Conformity UK Medical Device Regulations 2

Similar threads

Top Bottom