UPDATE UKCA; UK 12 month extension (Future regulation of medical devices - extension of standstil period)

Newbie22

Newbie22

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#1
#1
Looks like we may have until July 2024 for the new UKCA regulation deadline!!!! (y):love:

More information should be made available by the MHRA soon

https:// medtech.pharmaintelligence.informa.com/MT145964/MHRA-Grants-Extra-Year-For-CE-Marked-Devices-To-Access-UK-Market
 
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Newbie22

Newbie22

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#2
#2
MHRAs publication on the 25th October!

Decision Implementation of the Future Regulations Published 25 October 2022:

https:// gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations
 
Q

Quj43909

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#3
#3
Hi - can anyone advise..
Our CE certificate actually expires on 23 Dec - we cannot get a re-audit date from our NB to audit us against MDR going forward. This means that in a month or so, not only do we have an expired certificate [so technically cannot apply CE mark and sell in EU] but also I am assuming we cannot sell in UK??? We have been chasing NB since March! :(
 
B

Billy Milly

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#4
#4
Unfortunately, your assumptions are correct. You will not be able to sell in EU until you certify your products to MDR (not only the audit, but submission of MDR-complant device file as one of first steps). To sell in UK, you need either CE or UKCA certificate - which can only be issued by 4 NBs (currently), all of them are overbooked.
Did you submit your MDR application? When, which NB?
 
M

Mazza

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#5
#5
Quj43909 said:
Hi - can anyone advise..
Our CE certificate actually expires on 23 Dec - we cannot get a re-audit date from our NB to audit us against MDR going forward. This means that in a month or so, not only do we have an expired certificate [so technically cannot apply CE mark and sell in EU] but also I am assuming we cannot sell in UK??? We have been chasing NB since March! :(
Click to expand...
We are in the same boat! We have been chasing our NB since our initial plans were submitted in July 2020! They didn't get their certification until Nov 2021 and then invited us to apply in Jan 2022. Our contract came through in Sept along with rather substantial fees and I have heard nothing since returning the contract and PO! Then I get a letter on 4th Oct saying there will quite probably be a gap in our CE certification, they cant say how long, but we cant get an extension to our current cert, will not entertain discussion and not responded to any further contact. They suggested possible solutions such as requesting our customers to stock build (for how long?), and pointed us in the direction of derogation applications (quite improbable to be granted!) Our CE cert and 13485 both expire in Feb 2023 so wont be able to sell anywhere - UK/EU or ROW.
 
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