Notified Body Debacle

Hoping for some advice/comments regarding our difficulty sourcing a Notified Body (NB). Here's the situation:

- We're not based in the EU, but would like to market our medical devices there.
- We've got a Class II(a) device, already on market in North America.
- We've got the Technical File prepared, complete with reports to applicable EC harmonized standards
- We've got ISO 13485 certification

For simplicity, we first approached our ISO 13485 registrar for NB services.
They say that, due to recent changes in NB system, the MHRA has warned that they cannot accept new business until they are re-accredited, but cannot give an estimate of how long this process will take.

So we started shopping around, and another organization is offering NB services (apparently they are not affected by the NB system changes our present registrar is dealing with).
...but they are saying we'd have to drop our current ISO registrar, and re-certify with them.
(I asked if we could leverage our current certification, they said no, we must go through the entire ISO 13485 certification process again...).

So my questions are:
- What's the deal with these "recent NB system changes"? Why are they (apparently) affecting some organizations but not others?
- Is it true that, if we go through another organization, we'd have to completely re-certify our ISO 13485 through the new organization?

Any comments or advice on how we can most simply CE-mark our device in this sorry state-of-affairs much appreciated.
Thanks in advance,
MM

 

My advice is just keep looking. Both responses you received are not acceptable.

 

Unfortunately I'm not well versed on EU regulatory process, but from what the 2nd organization is suggesting, our ISO 13485 certificate must be updated to include additional MDD requirements (much like CMDCAS for Canada). So, because our present ISO 13485 certificate is through another organization, they can't do this update without doing the entire ISO 13485 certification process themselves from scratch.

Is this accurate? If so, I'd presumably be the same situation regardless of who we found...

 

One way around ... You have to appoint an EU authorized representative. Select a competent EU rep who will also be able to get you a good NB with all your status clearly communicated.

 

No, in principle this is NOT accurate and not acceptable. Any NB should be able to leverage an existing accredited ISO 13485 certification. They might need to run their own audit to issue an EC certificate (MDD), but shouldn't normally duplicate the ISO 13485 certification component. Sounds like you are being manipulated into more business than is necessary.

When shopping around it's never wise to give up the search just on the basis of what the first seller you encounter tells you.

 

You don't need to have your ISO 13485 certification with the same notified body who provided the MDD certification. I know of several companies that have them with different NB's. The issue is that you will then have the costs involved from two certifications. Also the NB that covers your CE marking will also evaluate areas of the quality system that impact directly on the MDD, e.g. handling of complaints and vigilance, post market surveillance, clinical evaluation.

As a side note you can as a company hold CE certifications from two different NB's as long as the devices are significantly different that are being certified.

What you need to be aware of is that the changes in how the NB's are working and the increased scrutiny that they are undergoing is putting them under pressure. This has resulted in them not taking new business on, this could be the problem that you are seeing with all of the regulatory authorities in the EU (not just MHRA) advising the NB's that shouldn't take more work on than they can cope with.

 

I can't tell from the quote whether it's referring to just the MDD areas or not. The line-items are "ISO 13485 + MDD Annex II initial audit, 2nd stage...". But the numbers certainly appear comparable to what we paid for our ISO 13485/CMDCAS... I'll have to seek clarification...

...but even so, why incur the cost of maintaining two certifications that cover the same areas?

Yes, this appears to be the situation. I found a brief article talking about this:
http://www.emergogroup.com/blog/201...impacting-european-notified-bodies-lead-times

Basically, it appears to be a case of regulation framework expanding way too fast, leaving businesses who want to enter the market (and those whose NBs are closing due to lack of resources) S.O.L.
...no time-frames given, or plans to remedy this as far as I can tell...

If there was ever a case of regulatory systems hindering markets, trade, and entrepreneurship, this would be textbook.

 

Regulatory systems by definition will always hinder markets, trade, and entrepreneurship. The ultimate question is what's best for the general public, and it will always be a trade-off between safety and availability / innovation.

 

Yes (alas), I know. Sometimes I wonder a political-cynic like me is cut out for regulatory work.

What I meant to say is that this is a particularly egregious example. PIP implant scandal, trade-offs...ya, I get it. ..but to make sweeping changes without resources or planning to actually accommodate them is just bad policy, plain and simple.

 

The responsibility for the allocation of resources rests with the notified bodies. Unfortunately many notified bodies as well as certification bodies cannot get out of the commodity box mindset that they've inserted themselves in. They keep competing on price alone leading to staff turnover excessively high, slow technical file reviews, unresponsive to the market needs. If they had the quantity and quality of professionals they would be able to serve the market much better. But that would require better paid auditors and support staff which would have to be supported by higher fees to the medical devices manufacturers.

To bring one of my favorite threads back from The Cove, the current situation in the medical device notified body sector is partially due to the fact that many companies like the blind gofer 3rd party auditor type.

 

I disagree with your assessment.
Notified bodies run like any other business that is subject to regulation they have no control over. If regulations change abruptly and are so sweeping that they suddenly cannot keep up, I don't see how they are at fault.

It's like if government were to suddenly announce that all power-plants must have upgraded generators, all their staff must be re-trained to the new technology, and these must be installed and inspected prior to resuming power-delivery...doing otherwise would be breaking the law. Then your power goes out. You call the power-plant and they say they're awaiting inspection (there is - as would be expected - a huge queue), and having difficulty trying to accommodate increased demand due to other power-plants that have had to shutdown. Are you going to blame the power-plant?

Unfortunately all these costs ARE ultimately going to be pushed on manufacturers. Team-NB has predicted that quotation process times are likely to double or triple, and timeframe between contract & delivery are likely to double. This is not to mention the cost of unannounced inspections and additional auditor training that will also be pushed onto manufacturers.

 

The changes were approved by the European commission back in October 2013, almost 30 months ago.

 

If you assume NBs are going to act in their interest (i.e. they WANT to accept new business, they WANT to re-certify current clients...), then it follows that they will make all efforts to get their affairs in order as soon as possible. The fact that this is STILL the state of affairs nearly three years later is only evidence that the commission acted without fully considering the ability of the system to accommodate the changes in any reasonable amount of time.

 

You assume that every NB leadership has business acumen and foresight, while, in my experience, many just react to the crisis du jour and their horizon does not extend beyond the next quarter. Also, it is very important to note that, besides the PIP scandal, there have been several other cases of MDD NB's (mainly in Eastern Europe) caught in fraud and wrongdoings. Competent Authorities have to have people's well being and safety as the primary goal; otherwise they would be derelict.

 

Actually the regulations have not changed since 2007 (effective 2010). I guess that in some instances the authorities HAVE shifted their focus in a way that burdened NBs, which the NBs could not (?) have predicted; however, I think that in most aspects some NBs were just "living the happy life" under slack oversight when the new expectations (actually a bit more aligned with existing regulations) hit them.

As Sidney has suggested, many manufacturers were happy with that "lazing in the sun" because it meant certification was cheaper and easier for them. The entire industry was aware of the "multi-tier" NB system, which allowed each to pick their flavour. Those organisations who stuck to the stricter NBs (typically also more expensive) had generally less surprises when the authorities finally decided to level the field.