What's the big picture on Notified Bodies?

[Julie O]

Can anyone give me the big picture on notified bodies? Like others, I've been hearing rumors of widespread panic among the NBs, as well as a range of activity (mergers, closings, refusing new clients) for awhile now.

I'm not sure if all if this is in anticipation of specific requirements for NBs in the new regulations, or if some other regulation or guidance has already been issued related to new standards for/re-designation of NBs.

Also, does anyone have an old list of NBs, maybe 2-5 years back? I'd be interested to track where they were before all the fun started, where they are now, and where they evolve as everything plays out, including Brexit.

It's a great time to be on the market in the EU, isn't it?

 

[Sidney Vianna]

Can anyone give me the big picture on notified bodies?

Are you talking specifically about the NB's involved in the Medical related directives?

I don't have an answer for you, but, after the PIP case in France, and a few other "scandals", it seems to me that some of the organizations acting as NB's in the medical sector are deeply reassessing the risk-reward situation.

On the risk side: Legal exposure can be huge and, even in cases when the NB is acquitted of wrong doing, the costs for the legal defense can be very steep. Regulatory oversight is not going to get any easier and technical demands will increase.

On the reward side: Even though conformity assessment services for NB's has not been as commoditized as in the unregulated management system certification sector, there is still significant price pressure.

With a potential consolidation of NB's, the market might turn into a seller's market.

 

[RobertvanBoxtel]

The NANDO website, although very late and slow, does provide the list of (in their opinion) current NB's. And also the old NB's are mentioned. This identifies the last update, not sure whether this is the actual date of becoming obsolete.

 

[pkost]

I think there are a multitude of factors that have led to the current situation with notified bodies, from my perspective:

1. 2007 recast...Introduced clearer requirements on things like clinical evaluations
notified bodies struggled to resource up, it took some time for the reviews to be reviewed (Not a huge issue, but the start of the struggles in my mind

2. PIP, MoM scandals ...led to new commission guidance, unannounced audits had to take place, joint assessement of notified bodies started
Some of the poorer notified bodies started to fail audits...this made it clear that authorities were not messing around; other notified bodies took note and rapidly tried to increase competence and resource; tried to adjust their models to suit; some were already good enough, but some are not. The increasing demand for competent assessors led to a market shortage that we are are still experiencing. This in turn has led to increased lead times, refusal to accept new customers etc. etc.

3. MDR/IVDR
The expectations on NBs are only getting higher, they all have this on the horizon and are trying to adjust so that they can comply; they are planning for the future but within the context the current environment, this is proving to be challenging



Ultimately, expectations on the oversight of medical devices are increasing to a level that I think it should have been at years ago. The industry and in particular notified bodies are struggling to meet this and are having to manage their customer base in the face of a rapid change of expectation.

It comes down to people and competence, I do not believe there is currently enough to go around and it takes time to train people up. The entire industry is struggling however NBs are a very noticeable bottleneck

 

[Ronen E]

There's some available competence down here... If you know of any NB looking for freelancers on this side of the world, feel free to send them my way