EU Commission requires NB (Notified Body) Unannounced Visits

[Ronen E]

IMHO regulations and standards are created to those that want to apply and be in conformity with them.

The PIP case was a police case, not a regulatory case.

There is a very fine line between the two. If you read the FDA published warning letters on a regular basis, you realize that many companies do not really want to comply with the regulation; they only do so to avoid their case becoming "a police case". Reasonable, given that the FDA is indeed a law enforcement body (sort of a police).

A brilliant legal system without real enforcement is not much better than a sloppy legal system. The problem is that real enforcement costs money. Once everyone agrees that enforcement is essential, and that the required funds will have to be put in to achieve anything meaningful, the discussion on how to do it effectively can begin. Coming to that, I do believe there are ways more clever and more effective to achieve both compliance and deterrence, though unannounced visits should be in the enforcement toolbox as a supplement.

Cheers,
Ronen.

 

[Marcelo]

There is a very fine line between the two. If you read the FDA published warning letters on a regular basis, you realize that many companies do not really want to comply with the regulation; they only do so to avoid their case becoming "a police case".

That?s not what I?m saying. The fine line in this case is in enforcement, not in the way the regulations or standards are written.

I understand that a lot of companies might not want to comply.

But when you create a standard or regulation, you usually create it "trusting" that the user will want to comply.

A regulation or standard created with the premise that user won?t comply would be a total different one.

Enforcemente is another matter, in fact.

If you are required to comply with a law, you are required and that?s it. You don?t need anyone veryfying this compliance, in fact.

 

[Ronen E]

when you create a standard or regulation, you usually create it "trusting" that the user will want to comply.

Why?... Are the authors just naive? See for yourself, as I mentioned regarding FDA warning letters. I estimate that the reason we don't get a similar impression for the EC is because there's little enforcement over there (well, much less than with the FDA), or just less transparency. But basically I believe the ratio of "willingly complying" to "hardly doing the bare minimum to avoid consequences" is similar on both sides of the Atlantic, and probably around the developed world (give or take).

Enforcemente is another matter, in fact.

Yes, but they go hand in hand. IMO a "trusting" regulation can only be effective if its accompanied by effective (not necessarily intensive) enforcement. Otherwise it's just wishful thinking.

If you are required to comply with a law, you are required and that?s it. You don?t need anyone veryfying this compliance, in fact.

This is true in principle, and would apply in a perfect world. But we already know that the world we live in is not perfect. The problem is not with the lawful majority; it's with the reckless minority abusing the above mentioned "trust". Even in very law-respecting cultures like Australia, there is a non-negligible percentage of individuals and companies that won't comply unless someone makes them (i.e. monitors their conduct and initiates proper action when violations are exposed). The reason that the vast majority complies in such cultures is that effective enforcement is in place (well, at least we'd like to believe so). I assume all this is true for the USA and the EC too. In some other parts of the world, where enforcement is not that effective, or even hardly exists, the result is caos, very much as if the regulations / legislation didn't exist in the first place. In short, my opinion is that legislation without effective enforcement is almost like no legislation. This has nothing to do with my personal preferences, it's just an observation on reality as I know it.

 

[Marcelo]

Why?... Are the authors just naive?

No, because it?s the general principle behind the type of regulation in the medical device sector (and standards in general as standards are voluntary good practices). It?s the manufacturer responsibility to be in compliance with the regulation, and the presumtion is that they will want to comply. It?s created for the majority that will want to comply, not for the minority that will try not to comply.

If you take a look at the tables at the document Principles of Conformity Assessment for Medical Devices you will see that the manufacturers has the responsibility to perform everything, and the regulator can verify, or can expect that it?s ok because the manufacturer said so.

So the focus is more on the responsibility of the manufacturer in complying than on the enforcement of the regulator.

If we were to create a regulation with a presumtion that the manufacturer will not comply, or focus on the minority, we would need a regulation with more of a focus on the enforcement. This would require more evaluation form the part of the regulator, more staff, more everything. I?m pretty sure that the trade-off is not good, because the minority that don?t want to comply would still do so, and the majority which wants to comply would be punished.

I think we are saying the same things here, but in different ways.

 

[Ronen E]

Thank you for the interesting discussion.

I think we are saying the same things here, but in different ways.

Mostly, but not entirely. I think that the regulation is generally fine as it is, but enforcement has to be revisited. Yes, commitment on the state's part and resource allocation are required, but above that a fresh (maybe clever) thinking is required. You don't need an army of auditors harassing all companies, you only need to pin-point the risk and outsmart the potential offenders in new ways.

If we always think the way we thought, we'll keep getting what we always got.

Cheers,
Ronen.

 

[Ron Boumans]

We have had a scandal with medical devices in 2010 - 2012 and recently we have had some problems with food: contaminated salmon, horse meat, free range eggs etcetera. We may soon see a similar problem with toys, personal protection equipment, biocides etcetera.

In my opinion this is caused because in all these legislations it is presumed that it is possible to represent the real quality by paper. We are now discovering that we have a reality that exists on paper without an unbreakable link to reality. Now we have to try to make a connection between these two. Unannounced inspections may be part of achieving that, but there might be more ways to do that.

This may sound like something that should be part a discussion that takes place not on this forum but on a very high level. I don't agree. Here we have the people that have to make that link between the real world and the paper reality every day.

As this is a question that involves many other fields we work in, maybe this question should be made into a new topic.

 

[Wes Bucey]

We have had a scandal with medical devices in 2010 - 2012 and recently we have had some problems with food: contaminated salmon, horse meat, free range eggs etcetera. We may soon see a similar problem with toys, personal protection equipment, biocides etcetera.

In my opinion this is caused because in all these legislations it is presumed that it is possible to represent the real quality by paper. We are now discovering that we have a reality that exists on paper without an unbreakable link to reality. Now we have to try to make a connection between these two. Unannounced inspections may be part of achieving that, but there might be more ways to do that.

This may sound like something that should be part a discussion that takes place not on this forum but on a very high level. I don't agree. Here we have the people that have to make that link between the real world and the paper reality every day.

As this is a question that involves many other fields we work in, maybe this question should be made into a new topic.

What you say is true, but the problem is essentially a police matter, not a quality one. Somewhere along the line, a crook says, "I can make more money by cutting corners, so I will."

The fact that the ramifications may include dead children and pets (melamine), illness, or injury does not matter to a sociopath.

These so-called "quality failures" are not failures, but intentional omissions.

If I send a different "snapshot" auditor every day to a plant (to avoid auditor collusion), it will just drive a determined crook to greater lengths to cover his tracks.

If we send "forensic" auditors to EVERY facility, we drive up the cost of goods and ruin the economy - worse, we drive legitimate folk out of business because we have effectively claimed EVERY manufacturer is a crook.

To carry the analogy to a ridiculous extreme, could we stop murder by treating everyone as a potential murderer? With such close observation, would we foment a violent revolution against big brother?

There may be a solution, but I doubt that it will be an "end all, be all" one because criminals soon learn how to defeat and avoid scrutiny from better locks and elaborate electronic surveillance systems.

Heck, I found myself fretting this morning because my favorite brand of coffee had shrunk the normal package by 3-1/2 ounces while raising the price 20 per cent, compared to another brand raising its price (same original package) by 25 per cent. It was certainly a sly move to increase profit while counting on folks to miss the fact that the similar-looking package was now smaller, touting its price increase was low while the real increase was closer to 40 per cent on a per ounce basis. The fretting part came, not because of the actual price increase, but, because of the duplicity, I began to wonder if the actual coffee was a lower grade, if it had been roasted properly, if it was bought from plantations which abused workers, or were not practicing good environmental protection policies.

My morning coffee is not yet a police matter, merely a personal consciousness one, but it could easily slip down the slippery slope, like "blood diamonds," milk scandals in Japan, melamine scandals in China, horse meat in Europe.

How can we instill DECENCY in everyone?

 

[Edward Reesor]

Question: I have been trying to gather more information on the unannounced audit requirement by the NB's and to date have only seen the Committee Recommendations for NB's and the Code of Conduct for NB's. From what I have seen, it was the EU Commission making recommendations to the Code of Conduct and not an actual regulatory change that could have been detected in updates. Numbered regulations can be (relatively) easy to scan for updates and changes, however the decision driving this particular change seemed to come from a different direction.

Which actual regulation was amended that speaks to the changes involving unannounced audits? In other words, for someone checking the regulations that affect their company how would they have been made aware of the changes other than their NB announcing it (or reading about it in this forum)?

 

[pkost]

There have been no changes to the regulations per se. The directive already permitted unannounced inspections and therefore no regulatory change was required...Monitoring changes to regulations would therefore fail to pick this up

The change in policy was driven by the breast implant scandel, which caused significant noise in the press and member state and european governments. Although I don't recall exactly, I believe there was a strong message from European parliament that the industry/member states needed to sort themselves out or the parliament would (via regulation).

Investigation into the problem indicated that there was a chance it could have been detected earlier if unannouced inspections were conducted, therefore changes were made to policies to implement this

with regards to picking this up:
1. It is not a change to legislation, you should already be compliant and should already be in a position to accept unannoucnted audits
2. there has been a lot of comment on this in the industry press - if you read it you would have seen it
3. A good relationship with your notified body would likely have highlighted it
4. External business relationships would likely have mentioned it

 

[Marcelo]

There have been no changes to the regulations per se. The directive already permitted unannounced inspections and therefore no regulatory change was required...Monitoring changes to regulations would therefore fail to pick this up

There were a lot of discussions as mentioned, and new guidance document was issued, so a good monitoring on the regulatory environment should have picked up the discussions and new documents.