- The UK left the European Union on January 31, 2020, meaning European law is no longer applicable and UK regulations have been updated. - England, Wales and Scotland follow UKCA requirements under previous MDD, while Northern Ireland follows MDR requirements under UK NI. - There is an ongoing transition period until June 30, 2023 where CE, UKCA, and UKNI certificates are all accepted. However, only three notified bodies are currently UKCA approved in the UK. - A UK government consultation on future medical device regulation proposed 3-5 year transitional periods depending on existing certifications, but the new regulations have not been published yet. - Progress has been slow with a lack of approved bodies

1. BREXIT: Where
are we?

2. SUMMARY
▪ I- Introduction
▪ II- Timeline
▪ III- Situation with the notified bodies
▪ V- results of the consultation
▪ VI- Conclusion

3. INTRODUCTION
What is Brexit and what it means ?
The referendum was done on 23.06.2016 regarding the United
Kingdom European Union membership and as a result UK left the
European union on 31.01.2020.
The European law is no longer applicable in UK
The regulations have been updated to reflect this
UK MDR 2002
The Medical Devices Regulations 2002 (legislation.gov.uk)
3

4. INTRODUCTION
What is the situation in UK?
England, Wales and Scotland
under MDD requirements
(UKCA)
North of Ireland under MDR
requirements (UK NI)
4

5. TIMELINE
5
Referendum
23.06.2016
UKCA starts
01.01.2021
End of the
transition
period
30.06.2023
Class I sterile
Registration
Registration of UK
responsible
person
01/01/2022
Class IIa and
IIb
IVD class B
Registration
01/09/2022
Class III and
IIb implantable
IVD class A
Registration
01/05/2022

6. TIMELINE
What certificate are accepted during transition period?
▪ CE certificates
▪ UKCA certificates
▪ UKNI certificates
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7. SITUATION WITH NOTIFIED BODIES
Only 3 notified bodies UKCA approved in UK?
- SGS (MD and IVD)
- BSI (MD and IVD)
- UL (IVD only)
Approved bodies for medical devices - GOV.UK (www.gov.uk)
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8. SITUATION WITH NOTIFIED BODIES
Guidance from MHRA
▪ Custom-made medical devices
▪ In-house manufacture of medical devices in Great Britain
▪ Vigilance
▪ Off label use
▪ Software applications
▪ Virtual manufacturing of medical devices
▪ Medicine and medical devices: product specific information
▪ Clinical investigation
Medicines, medical devices and blood regulation and safety: Medical devices
regulation and safety - detailed information - GOV.UK (www.gov.uk)
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9. RESULTS OF CONSULTATION
Consultation from UK Government on the future regulation of
medical device
Started on 16/09/2021 and closing on 25.11.2021
Results published on 26.06.2022
17 chapters of questions to complete
Answers from the participants published in term of percentages and
comments
Position of the government
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10. RESULTS OF CONSULTATION
Proposal of the government on the transitional period in the new
regulation
3 years for UKCA approved medical devices and 5 years for IVDs or until
certificate expires (which ever is sooner)
3 years for MDD, AIMD approved medical devices and 5 years for IVDs or
until certificate expires (which ever is sooner)
5 years for MDR approved medical devices or until certificate expires
(which ever is sooner)
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11. CONCLUSION
Slow Progress
Not enough approved bodies
Lack of resources from MHRA
New regulation closer to MDR, When?
Lots of confusion
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12. QUESTIONS
We have a valid CE mark certificate according to MDR 2017/745
can we continue to place the product on the market after
30.06.2023 for 5 years?
No because the current regulation requires UKCA from 01.07.2023
We have to wait for the new regulation to be published to check
from when a 5 years transition period is applicable
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