Informational BSI certifies first product to the Medical Devices Regulation

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JoshuaFroud

Involved In Discussions
#3
I wonder what will be the status of this certification upon a no-deal Brexit.
The certificate will probably (hopefully) have been issued under the BSI notified body office in the Netherlands ensuring it still holds validity after a no-deal Brexit.
 

Mikilk

Involved In Discussions
#4
The certificate will probably (hopefully) have been issued under the BSI notified body office in the Netherlands ensuring it still holds validity after a no-deal Brexit.
As far as I know, BSI Netherlands has not been accredited yet to MDR so they cannot issue MDR certificate, but I had the same thought....
please note the title :
BSI first UK notified body to achieve successful MDR designation
 

JoshuaFroud

Involved In Discussions
#5
Good spot! Whelp, that is going to be the shortest valid certificate yet!

Without getting too political, if the tax avoiders get their way the certificate will only be valid for another 57 days!
 

Marcelo

Inactive Registered Visitor
#6
Some companies are getting a BSI UK certificate even in the possible even of a no-deal Brexit as a way to mitigate regulatory risks related to other certificates they may already have and are either on the end line of validity or there is an identified risk of they getting cancelled (for example, due to a design change). I was in fact advising clients to do just that some months ago, but after the recent shakedowns, my estimate is that the no-deal scenario is too uncertain to follow this route. However, this is really a business decision related to regulatory risk (I don't know if this is the case of the manufacturer mentioned here, I'm just commenting that may be valid business reasons for this).
 

PVC Barbie

Starting to get Involved
#7
Does anyone know how to find out what kind of medical device was the first certified to the EU MDR? Is there anything publicly available...perhaps on Eudamed?
 
#9
Does anyone know how to find out what kind of medical device was the first certified to the EU MDR? Is there anything publicly available...perhaps on Eudamed?
"The product is classified as a IIa device under Rule 20 for the MDR. " Therefore it is probably a surgically invasive device, which isintended to administer medicinal products by inhalation.
 
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