This message was posted by a user wishing to remain anonymous
We have already started working on our Plan B. Transferring notified bodies can take 3-6 months or longer. And, you need to find one that you are confident can carry you through MDR (ie, has applied for designation and expects to get accredited for your scope of devices). I suggest laying out all your options with the pros / cons / risks of each and weighing or ranking them. It will likely become clear what steps you need to take.
What we are hearing is that currently it's estimated at a 60% chance of a hard Brexit in March and that if there is agreement to extend, that will likely come at the 11th hour. With the political climate over there right now, I wouldn't be completely surprised if they went through with a hard Brexit, but I would hope that if they aren't ready, then they wouldn't be so short-sighted to do so, as it would impact not only the UK but all of Europe. So, we are still hopeful...
Original Message:
Sent: 07-Aug-2018 03:21
From: Anonymous Member
Subject: BSI UK MDR and Brexit
This message was posted by a user wishing to remain anonymous
Thank you for the fresh update. If there will be a Withdrawal agreement which gives implementation period up till December 2020, there is no problem.
Do you believe the Withdrawal agreement will be achieved?
If all your medical device CE marks were issued by a UK NB, how long would you wait before taking plan B (i.e. transfer them to an EU NB)?
We have heard that BMW and Airbus will wait until October.
Original Message:
Sent: 06-Aug-2018 11:58
From: Paul Brooks
Subject: BSI UK MDR and Brexit
MHRA has published further Brexit guidance information and details of the proposed transition period through December 2020 regarding the impact of Brexit on healthcare products according to how MHRA understands today's situation (including CE Marking and UK NBs). It might be worth reviewing the following web link:
RAPS Regulatory Focus will continue to report on these and all other essential regulatory developments see:
Please ensure you are subscribed to RAPS Regulatory Focus to receive all essential regulatory updates.
Paul
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Paul Brooks
Executive Director
Rockville MD
United States
Original Message:
Sent: 03-Aug-2018 03:35
From: Anonymous Member
Subject: BSI UK MDR and Brexit
This message was posted by a user wishing to remain anonymous
Thank you for the comments so far.
Can anyone shed some light on what is the expected effect if Hard Brexit takes place in March 2019, and BSI UK clients haven't been able to transfer their MDD CE marks to another European NB (BSI Netherlands or other)? Can BSI UK clients sell their current stock? They probably are not allowed to manufacture new products under the old CE mark.
Has anyone else this kind of risk in their company? If so, are you planning to wait until the end of 2018 for BSI to issue CE mark transfer or are you planning to start negotiations with another NB?
Any thoughts are welcome and appreciated.
Original Message:
Sent: 02-Aug-2018 14:38
From: Rachel Thornton
Subject: BSI UK MDR and Brexit
To our understanding, Brexit will primarily affect MDD devices (MDR transition will be effective only in 2020 with soft transition to MDD certified devices up to 2022).
Along the lines of what Sebastian said... BSI applied to the Dutch HA for both regulations MDD and MDR. It is likely that MDD designation will occur before end of 2018, which may give sufficient time to transfer certificates before March 2019 in case of hard Brexit. For additional information, you can visit the BSI blog page at https://www.bsigroup.com/en-GB/medical-devices/brexit-medical-devices/
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Rachel Thornton
Associate Director
Smyrna GA
United States
Original Message:
Sent: 02-Aug-2018 04:56
From: Sebastian Clerkin
Subject: BSI UK MDR and Brexit
with respect to BSI and Brexit, i do think they will get designation in Holland as well. I was at a conference recently and BSI were very confident they would obtain this. Although this would mean they would need to obtain a new designation number from the dutch regulator.
the other query in this thread i believe is more around the impact of MDR/IVDR and MDSAP on the ability of our Notified bodies to meet their customer needs. i think they are struggling and i only see it getting worse.
Interesting times ahead,
seb
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Sebastian Clerkin
Consultant
Ballincollig
Ireland
Original Message:
Sent: 01-Aug-2018 04:51
From: Anonymous Member
Subject: BSI UK MDR and Brexit
This message was posted by a user wishing to remain anonymous
Hi,
this information is related to Brexit (not to the MDR transition). See EU communication/press release July 18, 2018:
Stakeholders, as well as national and EU authorities, therefore need to prepare for two possible main scenarios:
- If the Withdrawal Agreement is ratified before 30 March 2019, EU law will cease to apply to and in the UK on 1 January 2021, i.e. after a transition period of 21 months.
- If the Withdrawal Agreement is not ratified before 30 March 2019, there will be no transition period and EU law will cease to apply to and in the UK as of 30 March 2019. This is referred to as the "no deal" or "cliff-edge" scenario.
Original Message:
Sent: 31-Jul-2018 10:50
From: Anonymous Member
Subject: BSI UK MDR and Brexit
This message was posted by a user wishing to remain anonymous
Personally, I think BSI Netherlands will be able to get designation, but we are looking at transferring.
Why do you say that in the case of a no-deal Brexit with no transition period the CE certs won't be valid after 31 March 2019? I believe the CE certs will still be valid until their expiry date, but BSI will not accept any applications for review under MDD after that date. Which I interpret as we cannot submit any significant changes or new products under MDD. So, effectively, our devices are sort frozen until we can implement MDR.
Original Message:
Sent: 31-Jul-2018 04:32
From: Anonymous Member
Subject: BSI UK MDR and Brexit
This message was posted by a user wishing to remain anonymous
Hi,
are there any BSI UK clients in the community? The company I work for has BSI UK as NB, and I wonder what plans others have regarding MDR and Brexit: are you waiting for BSI Netherlands to get designation to MDR and transfer certificates there, or is the time limit already too tight? In case of a no-deal Brexit with no transition period, BSI UK's CE marks wouldn't be valid after 31 March 2019...
Any comments or thoughts would be appreciated.