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Impact of Brexit, Swixit, Turkxit for the European Medical Device Market

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Greenlight Guru
Greenlight Guru

Brexit, Swixit, and Turkxit will impact the medical device market in Europe in the following ways: 1) After January 1, 2021, UK manufacturers will need to use a new UKCA marking and will lose recognition of their CE marks unless they take action. Northern Ireland will still recognize CE marks. 2) Switzerland's vote to end free movement could impact its mutual recognition agreement with the EU, requiring Swiss and EU manufacturers to take new steps for market access depending on if a new agreement is reached. 3) Unless Turkey's customs agreement is updated, Turkish manufacturers may lose access to the EU market after May 26, 2021 as the EU MDR and IVDR are not currently

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Impact of Brexit, Swixt and Tukxit in Europe EASY MEDICAL DEVICE DECEMBER 8TH, 2020 1
MEDICAL DEVICE QUALITY IS ALL WE DO, AND WE’RE ALWAYS AHEAD OF THE GAME. © Copyright 2020 by Greenlight Guru
 Medical Device Expert specialized in Quality and Regulatory Affairs  Blogger, Youtuber, Podcaster  15 years of experience in the Medical Device industry within big companies (Bbraun medical, Bausch + Lomb, Johnson & Johnson)  Easy Medical Device is a Consulting firm helping Medical Device manufacturers to place compliant medical devices in the EU Market Monir El Azzouzi ©Copyright 2020 Easy Medical Device GmbH 3
©Copyright 2020 Easy Medical Device GmbH 4 Agenda Situation Brexit Swixit Turkxit
Before the exists Brexit, Swixit and Turkxit ©Copyright 2020 Easy Medical Device GmbH 5
European Union 93/42/EC 98/79/EC 90/385/EEC ©Copyright 2020 Easy Medical Device GmbH 6
New legislations 7 Active Implantable Medical Device Directive 90/385/EEC In-Vitro Medical Device Directive 98/79/EC Medical Device Directive 93/42/EC Medical Device Regulation 2017/745 In Vitro Medical Device Regulation 2017/746 ©Copyright 2020 Easy Medical Device
BREXIT ©Copyright 2020 Easy Medical Device GmbH 8
Consequence of BREXIT  From January 1st, 2021 the United Kingdom will not be part anymore of the European Union  Notified Bodies located in the UK will lose their accreditation  Authorized Representatives in the UK will not be authorized anymore for the EU market  Importers located in the UK will not be able to import products for the EU Market anymore ©Copyright 2020 Easy Medical Device GmbH 9
Is Northern Ireland in the UK?  EU MDR and EU IVDR will apply in the Northern Ireland  UK manufacturers will need to have an EU or Northern Ireland based Authorized Representative  If a UK Notified Body understake third party conformity assessment a UKNI mark will be required  Some product for the Northern Ireland market needs registration within MHRA ©Copyright 2020 Easy Medical Device GmbH 10
Dates to remember ©Copyright 2020 Easy Medical Device GmbH 11 Dates Activities 1 January 2021 New route to market and product marking (UKCA) will be available for the manufacturers who intend to place a medical device on the GB market. Until 30 June 2023 GB will continue to recognize CE marking and certificates issued by European Economic Area (EEA) based Notified Bodies will continue to be valid 01 July 2023 Mandatory from 1 July 2023 to place a device on the GB market with UKCA mark
Can I sell Medical Device in these markets after 31 December 2020??? 12 Mark Great Britain Northern Ireland (NI) EU Notified body CE Medical devices manufacturers do not need to use the UKCA mark until 30 June 2023. So, yes, they can sell but may be with additional registration requirements and other operational challenges Yes Yes EU-based UKCA Yes No No UK-based UKNI No Yes No UK-based
Which Risk Classification do you fall in??? Grace period for registration details Classifications Deadline for Registration • Active implantable medical devices • Class III medical devices • Class IIb implantable medical devices • IVD List A 4 months to register with the MHRA (until 30 April 2021) • Class IIb non-implantable medical devices • Class IIa medical devices • IVD List B • Self-test IVDs 8 months to register with the MHRA (until 31 August 2021) • Class I medical devices • General IVDs 12 months to register with the MHRA (until 31 December 2021) 13
Labels ©Copyright 2020 Easy Medical Device GmbH 14 S4M EUROPE 59 Rue Castellion 01100 Oyonnax 0123 Easy Medical Device 125 Deangate Manchester, UK M3 2LH
© 2020 Easy Medical Device GmbH – Monir El Azzouzi 15 Manufacturer End - User Distributor Importer EAR EU NB UK Manufacturer Northern Ireland Importer ?
© 2020 Easy Medical Device GmbH – Monir El Azzouzi 16 Manufacturer End - User Distributor Importer UK Rep UK Approved Body EU Manufacturer Accepted until June 30th, 2023 Northern Ireland End - User If UK Approved Body Importer ?
Anindya Mookerjea Managing Director/UK Responsible Person ©Copyright 2020 Easy Medical Device GmbH 17 Phone: +44 161 543 6588 Mobile: +44 745 915 3907 Address: 125 Deansgate, Manchester, UK M3 2LH Email: amookerjea@easymedicaldevice.com
SWIXIT ©Copyright 2020 Easy Medical Device GmbH 18
Mutual Recognition Agreement  Not part of the European Union  Agreement in place  Medical Device exceptional situation  Notified Bodies will not be accredited for CE marking anymore ©Copyright 2020 Easy Medical Device GmbH 19
Swiss votation  Votation to say Yes or No to free movement of people coming from the European Union ©Copyright 2020 Easy Medical Device GmbH 20 Result: YES
MRA negotiation  Negotiation in progress  If MRA signed before May 26th, 2021  If MRA signed after May 26th, 2021 ©Copyright 2020 Easy Medical Device GmbH 21
©Copyright 2020 Easy Medical Device GmbH 22 Manufacturer End- User Distributor Importer EAR Swiss will accept CE marked Products
TURKXIT ©Copyright 2020 Easy Medical Device GmbH 23
Turkey situation  Custom agreement recognize 93/42/EC, 98/79/EC, 90/385/EEC  Notified Bodies located in Turkey can certify for CE marking under MDD  No need of Authorized Representative ©Copyright 2020 Easy Medical Device GmbH 24
Custom agreement  EU MDR and IVDR not on the custom agreements  By May 26th, 2021 Turkey will be out of the Medical Device market  Turkish manufacturers will need an Authorized Representative and importer located in the EU ©Copyright 2020 Easy Medical Device GmbH 25
Notified Bodies for MDD ©Copyright 2020 Easy Medical Device GmbH 26
Not clear  Is the EC certificate issued by a Notified Body outside of the EU Agreement still valid.  Article 120 of the EU MDR ©Copyright 2020 Easy Medical Device GmbH 27
Summary ©Copyright 2020 Easy Medical Device GmbH 28
© 2020 Easy Medical Device GmbH – Monir El Azzouzi 29 Manufacturer End - User Distributor Importer EAR EU Notified Body
Questions Easy Medical Device GmbH Bernouillstrasse 20 – 4056 Basel Switzerland Website: EasyMedicalDevice.com Email: melazzouzi@easymedicaldevice.com Tel: +41 79 90 36 836 ©Copyright 2020 Easy Medical Device 30

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Impact of Brexit, Swixit, Turkxit for the European Medical Device Market

  • 1. Impact of Brexit, Swixt and Tukxit in Europe EASY MEDICAL DEVICE DECEMBER 8TH, 2020 1
  • 2. MEDICAL DEVICE QUALITY IS ALL WE DO, AND WE’RE ALWAYS AHEAD OF THE GAME. © Copyright 2020 by Greenlight Guru
  • 3.  Medical Device Expert specialized in Quality and Regulatory Affairs  Blogger, Youtuber, Podcaster  15 years of experience in the Medical Device industry within big companies (Bbraun medical, Bausch + Lomb, Johnson & Johnson)  Easy Medical Device is a Consulting firm helping Medical Device manufacturers to place compliant medical devices in the EU Market Monir El Azzouzi ©Copyright 2020 Easy Medical Device GmbH 3
  • 4. ©Copyright 2020 Easy Medical Device GmbH 4 Agenda Situation Brexit Swixit Turkxit
  • 5. Before the exists Brexit, Swixit and Turkxit ©Copyright 2020 Easy Medical Device GmbH 5
  • 7. New legislations 7 Active Implantable Medical Device Directive 90/385/EEC In-Vitro Medical Device Directive 98/79/EC Medical Device Directive 93/42/EC Medical Device Regulation 2017/745 In Vitro Medical Device Regulation 2017/746 ©Copyright 2020 Easy Medical Device
  • 8. BREXIT ©Copyright 2020 Easy Medical Device GmbH 8
  • 9. Consequence of BREXIT  From January 1st, 2021 the United Kingdom will not be part anymore of the European Union  Notified Bodies located in the UK will lose their accreditation  Authorized Representatives in the UK will not be authorized anymore for the EU market  Importers located in the UK will not be able to import products for the EU Market anymore ©Copyright 2020 Easy Medical Device GmbH 9
  • 10. Is Northern Ireland in the UK?  EU MDR and EU IVDR will apply in the Northern Ireland  UK manufacturers will need to have an EU or Northern Ireland based Authorized Representative  If a UK Notified Body understake third party conformity assessment a UKNI mark will be required  Some product for the Northern Ireland market needs registration within MHRA ©Copyright 2020 Easy Medical Device GmbH 10
  • 11. Dates to remember ©Copyright 2020 Easy Medical Device GmbH 11 Dates Activities 1 January 2021 New route to market and product marking (UKCA) will be available for the manufacturers who intend to place a medical device on the GB market. Until 30 June 2023 GB will continue to recognize CE marking and certificates issued by European Economic Area (EEA) based Notified Bodies will continue to be valid 01 July 2023 Mandatory from 1 July 2023 to place a device on the GB market with UKCA mark
  • 12. Can I sell Medical Device in these markets after 31 December 2020??? 12 Mark Great Britain Northern Ireland (NI) EU Notified body CE Medical devices manufacturers do not need to use the UKCA mark until 30 June 2023. So, yes, they can sell but may be with additional registration requirements and other operational challenges Yes Yes EU-based UKCA Yes No No UK-based UKNI No Yes No UK-based
  • 13. Which Risk Classification do you fall in??? Grace period for registration details Classifications Deadline for Registration • Active implantable medical devices • Class III medical devices • Class IIb implantable medical devices • IVD List A 4 months to register with the MHRA (until 30 April 2021) • Class IIb non-implantable medical devices • Class IIa medical devices • IVD List B • Self-test IVDs 8 months to register with the MHRA (until 31 August 2021) • Class I medical devices • General IVDs 12 months to register with the MHRA (until 31 December 2021) 13
  • 14. Labels ©Copyright 2020 Easy Medical Device GmbH 14 S4M EUROPE 59 Rue Castellion 01100 Oyonnax 0123 Easy Medical Device 125 Deangate Manchester, UK M3 2LH
  • 15. © 2020 Easy Medical Device GmbH – Monir El Azzouzi 15 Manufacturer End - User Distributor Importer EAR EU NB UK Manufacturer Northern Ireland Importer ?
  • 16. © 2020 Easy Medical Device GmbH – Monir El Azzouzi 16 Manufacturer End - User Distributor Importer UK Rep UK Approved Body EU Manufacturer Accepted until June 30th, 2023 Northern Ireland End - User If UK Approved Body Importer ?
  • 17. Anindya Mookerjea Managing Director/UK Responsible Person ©Copyright 2020 Easy Medical Device GmbH 17 Phone: +44 161 543 6588 Mobile: +44 745 915 3907 Address: 125 Deansgate, Manchester, UK M3 2LH Email: amookerjea@easymedicaldevice.com
  • 18. SWIXIT ©Copyright 2020 Easy Medical Device GmbH 18
  • 19. Mutual Recognition Agreement  Not part of the European Union  Agreement in place  Medical Device exceptional situation  Notified Bodies will not be accredited for CE marking anymore ©Copyright 2020 Easy Medical Device GmbH 19
  • 20. Swiss votation  Votation to say Yes or No to free movement of people coming from the European Union ©Copyright 2020 Easy Medical Device GmbH 20 Result: YES
  • 21. MRA negotiation  Negotiation in progress  If MRA signed before May 26th, 2021  If MRA signed after May 26th, 2021 ©Copyright 2020 Easy Medical Device GmbH 21
  • 22. ©Copyright 2020 Easy Medical Device GmbH 22 Manufacturer End- User Distributor Importer EAR Swiss will accept CE marked Products
  • 23. TURKXIT ©Copyright 2020 Easy Medical Device GmbH 23
  • 24. Turkey situation  Custom agreement recognize 93/42/EC, 98/79/EC, 90/385/EEC  Notified Bodies located in Turkey can certify for CE marking under MDD  No need of Authorized Representative ©Copyright 2020 Easy Medical Device GmbH 24
  • 25. Custom agreement  EU MDR and IVDR not on the custom agreements  By May 26th, 2021 Turkey will be out of the Medical Device market  Turkish manufacturers will need an Authorized Representative and importer located in the EU ©Copyright 2020 Easy Medical Device GmbH 25
  • 26. Notified Bodies for MDD ©Copyright 2020 Easy Medical Device GmbH 26
  • 27. Not clear  Is the EC certificate issued by a Notified Body outside of the EU Agreement still valid.  Article 120 of the EU MDR ©Copyright 2020 Easy Medical Device GmbH 27
  • 28. Summary ©Copyright 2020 Easy Medical Device GmbH 28
  • 29. © 2020 Easy Medical Device GmbH – Monir El Azzouzi 29 Manufacturer End - User Distributor Importer EAR EU Notified Body
  • 30. Questions Easy Medical Device GmbH Bernouillstrasse 20 – 4056 Basel Switzerland Website: EasyMedicalDevice.com Email: melazzouzi@easymedicaldevice.com Tel: +41 79 90 36 836 ©Copyright 2020 Easy Medical Device 30