If NB's (notified bodies) cannot be trusted how can we?

M

MIREGMGR

#11
Canada seems to have the right approach, though likely still not rigorous enough...but at least they kicked out one bad actor.

US FDA might (eventually) approach the problem from the opposite direction, by (eventually) requiring that device companies be annually QSIT 1 inspected by an NB...this being the eventual goal of the VARS program, I think...with FDA only accepting well-reputed NBs into the program.

Either of these approaches...Canada's discipline or US FDA's membership selectiveness...could have a positive effect on global NB marketing if its existence became more commonly known.
 
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Ronen E

Problem Solver
Staff member
Moderator
#12
I too have been following the Telegraph stories that have appeared over the last couple of days and agree with Pads that they have been rather sensationalist and of poor journalistic quality.

It is obvious in all cases that if you want to break the law, dodge the system, generally behave in an unethical manner then it really isn't that difficult to do so. This is not a fault of the regulation it is a fault of people. The law currently gives adequate provision to prevent detect this; it perhaps just needs more resource and a more uniform application across the EU.

There have been two high profile cases in the last few years regarding medical devices - PIP and MoM....From this the press is jumping up and down saying that the system is broken....is it really? two cases? hmmm...how many products have been stopped or improved as a result of NB review and surveillance? How many FSCAs are there to improve the safety and efficacy of devices? Let's have some balance here.

In response to the comments about the FDA system being so much better...are you truly so naive to think that you don't have similar abuses within your system that have slipped through? Although the warning letters are indicative of a functioning monitoring system they also show that there are failings and there are problems.

No regulatory system is perfect. The new MDR is an attempt to improve and correct issues that have been identified since the introduction of the MDD. But it is important to remember that if the industry is over regulated then innovation is stifled, products will take longer to reach market and patients will suffer in the mean time.

[/soapbox]
Hi P,

In general I agree with most of your comments. However:

This isn't about "who's better". Of course the FDA and its regulatory system aren't perfect. It's just that in some aspects this system seems to work better, and the real important question is whether or not other systems could learn and improve from such strengths. First off, the FDA seems to present a much less fragmented approach than the EC system. Not sure much can be done about that, due to the very nature of the EC vs. the USA. Second, FDA staff are considered [generalization, I know] law enforcement agents; I don't see the parallel of that in the EC. These are just 2 examples, I'm not here to try a comprehensive comparison; the point is that there ARE significant differences, and anyone interested in improvement should be looking into what can/should be brought over (at least partially), and how.

Regarding legal provisions - yes, there are some in place but my impression is that not enough. Maybe I'm not looking in the right direction, but if you look at the MDD and follow the pointers from it, you end up with nothing close to the FDA's enforcement toolbox. I'm sure some dodgy companies try playing games with the FDA too, but at least there seems to be an active system in place, trying to identify them and hold them accountable. PIP made it to the headlines because it had a high sales-promotion potential for the media, but that doesn't mean there aren't smaller scale parallels going on, on a regular basis.

Last, over-regulation and slowing progress aren't the only alternative to ineffective or lacking postmarket enforcement. The pendulum doesn't have to go all the way to the other end; the trick is to find a good balance. I feel that FDA is very concerned with not overburdening innovators (whether or not they succeed is a different question), yet in general it doesn't imply slack in enforcement. In the EC, my general impression is that there is too little postmarket enforcement (maybe in some member states the situation is better than in others), and I'm not sure this is in the name of innovation and patient good.

Maybe it's all just because the FDA communicates better with the public; I can't tell for sure because I live neither in the USA nor in the EC.

Cheers,
Ronen.
 
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G

Gert Sorensen

#13
I too have been following the Telegraph stories that have appeared over the last couple of days and agree with Pads that they have been rather sensationalist and of poor journalistic quality.

It is obvious in all cases that if you want to break the law, dodge the system, generally behave in an unethical manner then it really isn't that difficult to do so. This is not a fault of the regulation it is a fault of people. The law currently gives adequate provision to prevent detect this; it perhaps just needs more resource and a more uniform application across the EU.

There have been two high profile cases in the last few years regarding medical devices - PIP and MoM....From this the press is jumping up and down saying that the system is broken....is it really? two cases? hmmm...how many products have been stopped or improved as a result of NB review and surveillance? How many FSCAs are there to improve the safety and efficacy of devices? Let's have some balance here.

In response to the comments about the FDA system being so much better...are you truly so naive to think that you don't have similar abuses within your system that have slipped through? Although the warning letters are indicative of a functioning monitoring system they also show that there are failings and there are problems.

No regulatory system is perfect. The new MDR is an attempt to improve and correct issues that have been identified since the introduction of the MDD. But it is important to remember that if the industry is over regulated then innovation is stifled, products will take longer to reach market and patients will suffer in the mean time.

[/soapbox]
Yes, there have been two highprofile cases, but that should not be at the forefront of the discussion. What should be there is all the cases that are out there, but does not make the headlines. Cases that the NB's are aware of, but does not respond to. Those cases are much more important to the patients, the professionals, the industry and the healthcare sector in general.
 
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K

kanwal

#14
The NBs are not under the control of the National Competent Authority - but under the national accreditation body. In UK it is UKAS. EU regulation 765/2008. There is also a Notifying Authority that finally approves the Notified Body - please see Glossary on Nando Website.

There are several critical issues related to this expose/ string operation as we call it in India.

1. As per the directive, it is the manufacturer who is responsible for the product, even if it is certified by a NB. Hence the appreciation of product liability by the market place is a critical aspect. Surprisingly there is very little news of product liability issues being raised in EU although the PIP issue is about 10 years old. It has little relevance now since PIP has been lliquidated.

2. Is this issue germane to the Eastern European countries only? To illustrate PIP was audited by TUV Rhineland. PIP is the French company that was manufacturing breast implants that have been in the controversy leading to a revision of the medical device regulations proposed on September 26, 2012 by EU.

The issue is much larger.
 
R

Reg Morrison

#15
An interesting acticle from the daily telegraph on the practices of some Eurpoean notified bodies.
http://www.telegraph.co.uk/health/h...-risk-by-implants-scam-says-Jeremy-Hunt.html#

Will these NBs be stripped of thier powers? should they? How much confidence do you have in your NB?

Rob
Well, the cases are going through the courts and a French court just released its ruling and it is very bad news for the Notified Body involved in this case. They have been ordered to pay millions of Euros in restitution. But they have won other cases.
 
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M

MIREGMGR

#16
I'm always unfavorably impressed when a third party auditor says that it's not their job to detect intentional non-compliance.

FDA, of course, does regard it as part of their job to discover and act against intentional non-compliance. They don't always succeed, but it's not for lack of seeing such action as part of their mission.

My observation is that the public is only mildly concerned (at least in USA) about instances of non-compliance due to a well intentioned but inadequate quality system. Obviously such situations are unacceptable, but they're also understandable. The public, though, is (in my view justifiably) outraged by systematic, intentional, profit-motivated cheating.

My understanding is that FDA's goal with the VARS program is eventually to offload periodic inspections of well-behaved companies onto approved NBs, so that all of FDA's own badge-carrying inspection assets can be devoted to much more rigorously searching for and nailing intentional cheaters.

I don't have any inside information, but my guess is that FDA reviews court cases just like everyone else, and will have been thoroughly disappointed by TUV Rheinland's defense that it's not their job to discover intentional cheating. I expect to see changes in the VARS Program such that NB-participants are required to legally affirm that for VARS-eligible audits, it is their job to make such discoveries and report them directly to FDA.

In my view, once that future FDA system-approach is in place, the comparative weakness of the EU approach at protecting the public will be even more obvious.
 
R

Reg Morrison

#17
I'm always unfavorably impressed when a third party auditor says that it's not their job to detect intentional non-compliance.
How many times I've heard (brainwashed?) third party auditors working for CB's and NB's telling the platitude: "my job is to look for compliance; not non-compliance". Silly boy, your job is to ASSESS the product or system and let the evidence decide if the situation is conforming or non-conforming....
The public, though, is (in my view justifiably) outraged by systematic, intentional, profit-motivated cheating.
The only rationale for deliberately cheating regulations and regulators is the profit at any cost, i.e., greed. ;)
 
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