Notified Bodies Backed Up?

[QM Becky]

Hi Folks,

I've got a NB that appears to be under the MHRA's microscope and reportedly, most if not all NBs are having some challenges with the new regulations and requirements being placed upon them. (I've not confirmed that, just "heard" about it). It appears that my NB is REALLY struggling, so much so that I've now been told that they are accepting ZERO new products for technical file review and addition to my EC Certificate. This presents a HUGE problem for me as I have 2 products waiting now, and a pipeline in the next few months of 3-5 new products to get their CE marks (added to our certificate).

I'm considering transferring NBs - I really don't want to, but I can't take this kind of delay and they don't seem to have an alternative route for me.

We JUST completed our recertification audit in May for our ISO, CMDCAS and MDD certificates, so I suspect a transfer would be fairly straightforward, but I also don't want to sit through another audit, given I just completed the "big"one. Yuck. This whole situation just stinks.

Is anyone else experiencing this? Have you been able to work through it in any way that you could share?

Thanks!

 

[Mark Meer]

Responding just to say we are in the same situation, but haven't decided what to do yet.

The sad thing is that we've maintained our ISO through our current registrar for some time now, and have a good working relationship.

It now appears that, in order to deal with the NB backlog, our main option is to abandon this registrar and transfer to another...

I hope I'm misreading the situations, and there are other alternatives...but so far, I haven't figured out how best to proceed....

 

[QM Becky]

Mark,
Same here... I really like our registrar and hate the idea of transferring but no product additions? 9-12 month backlog for what's already in que? I just can't make that work.

 

[yodon]

I have a client that just went through their initial certification audit with the NB and were then told the backlog for the Technical File review is backed up over 6 months. They apparently discussed the option to have a different NB do the Technical File review and authorize CE marking. I was rather surprised to hear this as an option but maybe it's possible (and a possible path?).

 

[Remus]

European Commision have introduced new regulations to Notified Bodies, and give lots of major and minor nonconformities. Indeed most of Notified Bodies certificate products with weak technical files, so now they are trying to fix them to save them self. Moreover most notified body don't have enough good technical specialist, and they can't find new people. (Because of old weak directive, most of Medical Device companies ommit QA and Regulatory departments)

Moreover, some people says with new regulation European Commision will decrease notified body numbers around 30 (now around 60).

So, most probably cost and time of certification will increase.

 

[pkost]

Continuing to add to this, it's my understanding that most NB's are backed up. Lead times are massive or they are just outright refusing to accept new customers/products.

As already noted, it is due to the increased oversight from the competent authorities. Essentially they are all under resourced and there is insufficient competence in the system to immediately switch extra capability. I'm regularly contacted by recruiters asking if I would be interested in working for one or another NB.

Ultimately, until they can recruit, train and retain the necessary reviewers it is going to stay like this. If not worse with the increased demands as a result of the upcoming regulation

 

[Mark Meer]

...Because of old weak directive...

Curious: Other than the PIP Breast Implant scandal (a clear case of fraud, perpetrated by a single company), can anyone provide a strong case that the previous framework was ineffective ("weak")?

I'd really like to see evidence of negative overall outcomes, when compared to a stricter framework (say the US FDA). For example, say, the number of medical-device related deaths in the US versus EU.

Does anybody know if there's any data collected on the number of adverse incidents, comparing incidents (per capita) in the US versus incidents in the EU (pre ammendments)?

 

[pkost]

Since when have a few inconvenient details been allowed to get in the way of some good old political posturing?

The other scandal besides PIP was metal on metal hip implants

 

[Mark Meer]

The other scandal besides PIP was metal on metal hip implants

Can you kindly link to where I can read more? Was this a specific company, or the entire hip-implant industry? Were they fraudulently dodging regulations, or were they just poorly designing their products?

If these incidents were a big deal, couldn't they have just tightened up on these particular items (through, for example, additional particular requirements), rather than overhaul the entire system for everyone?!

(Sigh) ...just frustrated...

 

[Sidney Vianna]

Read the article @ http://www.telegraph.co.uk/news/hea...t-risk-by-implants-scam-says-Jeremy-Hunt.html