Dear Dan,
That's correct. There was no request from the UK for an extension and the deadline for making such a request has now passed. IP completion day is set for 31 December 2020 and after that date, as far as the EU 27 is concerned, the UK will be just like any other non-EU country.
My opinion: Those likely to be most affected will presumably be UK manufacturers selling into the EU or non-EU manufacturers with a UK Authorised Rep or Notified Body. However, given that those companies were already given three "no deal Brexit" deadlines to prepare, one can imagine that most should be ready for 31 December 2020. That leaves manufacturer's selling CE marked devices into to the UK. It would be political suicide if MHRA started blocking medicines or devices on 1 January, which had been freely available on 31 December. That's why I think the CE marking has been retained, at least for the time being.
------------------------------
Kevin Painter
Mentor, Medical Device Regulatory Compliance
Poland and United Kingdom
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Original Message:
Sent: 01-Jul-2020 10:21
From: Dan O'Leary
Subject: Brexit transition timelines
Kevin,
Thank for the summary of the regulations. I'm still absorbing it.
My understanding is that "Implementation period completion day" is now set for December 31, 2020. If it were to change, there would need to be an agreement reached before July 1, 2020.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 27-Jun-2020 18:10
From: Kevin Painter
Subject: Brexit transition timelines
Hi Dan. There is another conversation/thread running on Brexit and I posted an attachment there containing a link and an explanation.
Yes, I also saw the proposed UK conformity assessment mark but it seems to have been put on hold for now as the new regulation still includes the CE mark. I'm sure it will come, but maybe not immediately.
Best regards
Kevin Painter
Original Message:
Sent: 6/27/2020 5:25:00 PM
From: Dan O'Leary
Subject: RE: Brexit transition timelines
Can you give a link to laws or at least a place to look.
At one point there was a plan for a separate UK mark. Is this still the plan?
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 25-Jun-2020 15:30
From: Kevin Painter
Subject: Brexit transition timelines
Dear all,
Brexit happened on 31 January 2020. The UK is no longer a member of the European Union.
Currently we are going through what is known as the "Implementation Period". During the implementation period, the UK is still treated as if it were still a member of the EU. However, the implementation period ends on "Implementation Period (IP) completion day". IP completion day is set for 31 December 2020, after which the UK will be a non-EU country just like the US or Canada.
The UK has now passed its own domestic laws in all areas previously covered by EU law. This is also true of our area. The UK's future medicines, medical devices and diagnostics regulations have been passed by the UK parliament and are available online. They will come into force on IP completion day. While it's theoretically possible that IP completion day could be delayed, I don't think anyone familiar with the UK considers that a serious possibility.
Concerning CE marking etc.: As the UK regulations are essentially a copy/paste of the EU's regulations, they require CE marking and virtually everything else you are familiar with from the MDD and MDR. Except that, manufacturers who supply devices to both the UK and EU markets, will need to appoint a representative in both markets and register their company and their devices in both markets.
Best regards
------------------------------
Kevin Painter
Mentor, Medical Device Regulatory Compliance
Poland and United Kingdom
Original Message:
Sent: 24-Jun-2020 23:57
From: Rashmi Pillay
Subject: Brexit transition timelines
Hi,
Can somebody confirm the Brexit transition timelines would stay the same as scheduled (31st Dec'20) ?Our EU authorised rep confirmed , as per the latest updates, Boris Johnson is not in favour of an extension. Is this correct ?
Thanks & Regards,
Rashmi Pillay
Regulatory Affairs Manager
Ellex
3-4 Second Avenue
Mawson Lakes SA, 5095
W ellex.com
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