This document discusses the challenges and opportunities for in vitro diagnostic medical devices in the UK post-Brexit. Currently, the EU Withdrawal Bill would make EU directives like the Medical Device Directive part of UK law but most provisions of new regulations like the Medical Device Regulation would not be. The UK government has said it will comply with the key elements of the MDR and IVDR, but there is uncertainty around the final outcome of Brexit negotiations. Medical device companies need to take action to ensure they can continue sales in the EU after 2020 when the transition period ends. The UK may also create opportunities through mutually recognizing regulations with other countries like the US and developing its own guidelines.

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In vitro Diagnostic Medical Devices
Challenges and opportunities in a post-Brexit UK
8 November 2018

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Unknowns
• Will the EU Withdrawal Bill be enacted essentially in current
form?
• Will there be mutual recognition with the EU?
• Will the Transition Agreement be agreed, or will the UK “crash
out of the EU”: the ultimate hard Brexit?
• Will the UK Government introduce laws bringing MDR/ IVDR
into UK law?
• ……or will there be something different?!

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Withdrawal Bill as Written Today: Future Two separate Bodies of Law
UK LAW from 30 March 2019
EU law enacted as UK law (Directives):
Become “stand-alone” UK law:
MDD/ AIMD/ IVDMDD
EU law with direct effect (Regulations):
Become part of “stand-alone” UK law ONLY if
both in force AND “applicable” at 29 March
2019:
Most provisions of MDR and IVDR will not be
part of UK Law on 30 March 2019
EU LAW
Gradual applicability of MDR and IVDR:
26 May 2020: MDR fully applicable
26 May 2022: IVDR fully applicable
Transition
EU law will apply in UK until 31 December 2020

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MDR no
longer
applicable
in UK
3
Current Flow of Legislation in UK: Per Current Documents
29 March
2019
UK Sovereign Law Applies per EU Withdrawal Act
31 December
202026 May 2020
EU law: MDD/ AIMD and
IVDMDD plus limited
provisions of MDR/ IVDR
EU law: MDR fully
applicable
EU
Law?
Transition
Agreement
EU
Withdrawal
Act: UK
Law
EU law applies in the UK
per Transition Agreement
26 May
2022
In EU (not UK) :
IVDR fully
applicable

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Will UK Government enact MDR and IVDR?
“The UK will comply with all key elements of the Medical Devices Regulation (MDR)
and the in vitro diagnostic Regulations (IVDR), which will apply in the UE from May
2020 and 2022 respectively”
How medicines, medical devices and clinical trials would be regulated if there’s no
Brexit deal (updated 14 September 2018)

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Medical Device Manufacturers: What to do, and when?
Action!!!

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Regulations: Making Sales in EU after 31 December 2020
Current UK notified body
UK Legal Manufacturer
29 March 2019
UK: EU27:
UK Authorised Representative
EU27 notified body
EU27 Legal Manufacturer
OR appoint AR in EU27
EU27 Authorised
Representative

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Interesting NB Dilemma: What about the UK?
So, now I
don’t have a
notified body
in the UK??

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Interesting NB Dilemma: What about the UK?
23 August Technical Note from MHRA:
“UK will recognise medical devices approved for the EU market
and CE-marked”

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R&D/ manufacturing/ regulatory functions/ HQ in UK?
• EU law does not prevent these being outside the EU27
• Just need other another entity inside EU to be holder of the
regulatory functions: legal manufacturer/ holder of CE
certificates for EU27 OR Authorised Representative
• MDR, Article 15: “Person responsible for regulatory
compliance”: no requirement to be in the EU27

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UK Opportunities
• MHRA: Focus on influencing international platforms and standards
• Potential to “mutually (or non-mutually) recognise” a number of laws - eg
US as well as EU?
• Is lighter regulation an opportunity?
• Lead the way in developing guidelines and standards in certain sectors?

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Any Questions?
Alison Dennis
Partner
Co-head of Life Sciences Sector
ABHI Legal and Compliance Committee Vice-Chair
T: +44(0)207 861 4637
M: +44 (0)7525 902 361
E: alison.dennis@fieldfisher.com