Difficulty Finding A Notified Body for CE Marking - No Capacity

Shonver

Starting to get Involved
#1
Edit: medical devices

We are having difficulty finding a notified body that is willing to accept our product(s) for CE marking purposes, due to lack of capacity. Our company is based in London, and would prefer to use a NB located close by (though, we are willing to go farther afield if circumstances dictate). I would like leads and recommendations for NBs that might be able to help. UK or Europe.

Thanks
 

JoshuaFroud

Involved In Discussions
#2
Good Morning Shonver, it may be worth waiting until the Brexit fiasco has resolved itself before choosing your notified body.

Without getting too political, in the event of a no deal, all UK notified bodies for CE marking will cease to be able to grant CE marks as UKAS will no longer be recognised and as such a NB based in Europe will be required.

If there is a deal that deal is likely to include provision for UKAS to still be recognised and UK NB's to continue operation granting CE marks.

So my suggestion would be to wait 20 days or so for the dust to settle into whatever there is left for it to settle to and consider your options at that point.
 

Shonver

Starting to get Involved
#3
Good Morning Shonver, it may be worth waiting until the Brexit fiasco has resolved itself before choosing your notified body.
I appreciate your very valid advice. I still have the problem, though, because the capacity issue extends to Europe. If I can at least find a NB with capacity, that will be more than I have right now.
 
#4
A year or so ago, I was on a webinar on the new MDR, where they gave the number of NB's that left the market. The numbers were astonishing (dropped by half), however it was worse was that they recognized that the number would drop further. I believe the number was 25-30% of the original number. It was felt that this was the price of public safety. Our NB left the market and instead of finding a new one, we withdrew from the market altogether. We experienced something similar in Canada when MDSAP became mandatory and many US and European based companies chose to leave the Canadian market.
 
#6
Has anyone had any luck with available Notified Bodies taking new clients? We are in the same boat as Shonver.
And are awaiting CE Marking for UK.
 

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