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Belgium | China | France | Germany | Italy | Luxembourg | Netherlands | UK | US (Silicon Valley) | fieldfisher.com
In vitro Diagnostic Medical Devices
Challenges and opportunities in a post-Brexit UK
8 November 2018
Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com1
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?!
Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com2
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
Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com
MDR no
longer
applicable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
Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com4
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)
Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com5
Medical Device Manufacturers: What to do, and when?
Action!!!
Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com6
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
Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com7
Interesting NB Dilemma: What about the UK?
So, now I
don’t have a
notified body
in the UK??
Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com8
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”
Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com9
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
Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com10
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?
Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com11
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

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  • 1. Belgium | China | France | Germany | Italy | Luxembourg | Netherlands | UK | US (Silicon Valley) | fieldfisher.com In vitro Diagnostic Medical Devices Challenges and opportunities in a post-Brexit UK 8 November 2018
  • 2. Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com1 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?!
  • 3. Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com2 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
  • 4. Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com 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
  • 5. Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com4 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)
  • 6. Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com5 Medical Device Manufacturers: What to do, and when? Action!!!
  • 7. Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com6 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
  • 8. Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com7 Interesting NB Dilemma: What about the UK? So, now I don’t have a notified body in the UK??
  • 9. Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com8 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”
  • 10. Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com9 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
  • 11. Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com10 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?
  • 12. Belgien | China | Frankreich | Deutschland | Italien | Niederlande | GB | USA (Silicon Valley) | fieldfisher.com11 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