Independence on Notified Bodies, inter alia of Manufacturers they Assess

[Ronen E]

The new MDR speaks a lot of NBs impartiality and independence, inter alia of Manufacturers they assess. Is that even possible where manufacturers hire the services of NBs, which are essentially commercial entities that need to stay financially afloat? Apparently there's a built-in conflict of interest - the NB would be interested to retain the Manufacturer as a returning client, and a Manufacturer refused certification or heavily burdened in the process would doubtfully be such a client (or any client, for that matter). Strict / fully impartial NBs might quickly find themselves out of business.

Just wondering what others are thinking about it, as it keeps haunting me as I read and re-read the MDR.

Thanks for your opinions,
Ronen.

 

[Sidney Vianna]

Re: Independence on Notified Bodies

That is the same challenge in the accredited management system certification business and we've had, over the years, numerous discussions on the subject. In my mind, it is very simple. Make the "price" to pay for certifying undeserving products, systems, processes, people, etc much much higher than the revenues the certifier receives for certifying such substandard item.

That's why we need robust accreditation bodies and competent authorities performing oversight. The system only works if oversight is effective. Otherwise, the bad actors prosper.

 

[Ronen E]

Re: Independence on Notified Bodies

Unfortunately there is a large grey area between clearly undeserving Manufacturers / devices and clearly compliant ones. In this grey area there's a built-in incentive to lower the bar while not bluntly breaching the regulatory requirements applicable to NBs. In the short run the drive may look like greed but in the long run it is a simple matter of survival, as we've seen in the dwindling numbers of medical devices NBs in recent years. You might say that a small number of (very) large NBs is enough but in my opinion over-centralising is bad in more than one way, and besides currently there's a real, simple issue of undersupply.

I have no doubt that technically the provisions and arrangements are in place to monitor (or police) substandard NBs. This is not the issue. The issue is that such successful policing (and impeccable NB impartiality / independence, super-strict application of the regulations etc.) seem to inevitably lead to economical inviability - either for the NB itself or for Manufacturers (through burden shift).

 

[Chrisx]

There are other ways to define independence besides financial interest. For example, has the employee of the notified body performing the conformity assessement ever consulted for this organization? Does the notified body have ownership in the client? Has the employee of the notified body performing the conformity assessment previously worked for the client? Did this employee write any of the documents that are subject to conformity assessment?

 

[Ronen E]

There are other ways to define independence besides financial interest. For example, has the employee of the notified body performing the conformity assessement ever consulted for this organization? Does the notified body have ownership in the client? Has the employee of the notified body performing the conformity assessment previously worked for the client? Did this employee write any of the documents that are subject to conformity assessment?

All these aspects are covered by the MDR, are relatively simple to check, and are possible to avoid. The problem I highlighted, on the other hand, is impossible to avoid. It's inherent in the way this system is structured.

 

[Edward Reesor]

NB's should be independent but should also be aware that they are providing a service (for a system that is voluntary as well). I know of companies that have switched NB's because they were throwing too many obstacles into their daily management despite them having very few non-conformities. If they're not willing to work with the companies and only offer findings with no proof that they will improve quality (i.e. an exercise in bureaucracy), then their services will no longer be needed.

Other NB's vying for business will offer additional services to prospective clients while maintaining an independent auditing partnership. I don't think that there is as much of an issue with independence because the NB isn't "embedded" on a full time basis with the company. I believe the best relationship is one where the NB may offer the best tools to maintain quality then have an auditor or two come in and see if they have been followed.

 

[Ronen E]

NB's should be independent but should also be aware that they are providing a service (for a system that is voluntary as well). I know of companies that have switched NB's because they were throwing too many obstacles into their daily management despite them having very few non-conformities. If they're not willing to work with the companies and only offer findings with no proof that they will improve quality (i.e. an exercise in bureaucracy), then their services will no longer be needed.

This is exactly the problem. NB are not there to "provide services" or improve quality (although this can be a by-product). NB are part of the EU regulatory system and are there first and foremost to provide oversight. The problem is demonstrated in your post in all its might - how can anyone provide independent, impartial oversight when their own economical viability (read survival) depends on the oversight subject being "happy" with the way it's being scrutinised...?

I'm not saying that the US system is perfect (or even better overall) but at least the FDA won't go "out of business" simply because Manufacturers it inspects are unhappy with it "throwing too many obstacles into their daily management", nor can those Manufacturers switch to more "easy-going" regulating entities thus providing such entities with an inherent incentive to lower the bar.

By the way, the MDR explicitly prohibits NBs from providing consultation services and auditing/certification to the same Manufacturer.

 

[Sidney Vianna]

I believe the best relationship is one where the NB may offer the best tools to maintain quality then have an auditor or two come in and see if they have been followed.

And how wouldn't that be a threat to impartiality? Just another example of loopholes sought by people who don't understand the damages to the credibility of conformity assessment.

While the comment might be offered with no malice, it exemplifies how conformity assessment principles are trumped upon when some stakeholders are willingly participating in the trivialization and monetization of certification.