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Impact of Brexit, Swixt

and Tukxit in Europe
EASY MEDICAL DEVICE
DECEMBER 8TH, 2020
 MEDICAL DEVICE QUALITY IS ALL WE DO,
AND WE’RE ALWAYS AHEAD OF THE GAME.

© Copyright 2020 by Greenlight

Guru
 Monir El Azzouzi 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

©Copyright 2020 Easy Medical Device GmbH

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Situation

Brexit

Agenda

Swixit

Turkxit

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Before the exists

Brexit, Swixit and Turkxit

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European Union
93/42/EC
98/79/EC
90/385/EEC

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New legislations

Active
Implantable
Medical Device
Directive
90/385/EEC Medical Device
Regulation
2017/745

In-Vitro Medical
Device Directive
98/79/EC

In Vitro Medical
Device
Regulation
2017/746
Medical Device
Directive
93/42/EC

©Copyright 2020 Easy Medical Device

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BREXIT

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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

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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

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Dates to remember

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 GB will continue to recognize CE
2023 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
©Copyright 2020 Easy Medical Device GmbH
 Can I sell Medical Device in these 12
markets after 31 December 2020???

Mark Great Britain Northern Ireland EU Notified body

(NI)

CE Medical devices manufacturers do not Yes Yes EU-based

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
UKCA Yes No No UK-based
UKNI No Yes No UK-based
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Which Risk Classification do you fall in???
Grace period for registration details

Classifications Deadline for Registration

• Active implantable medical devices 4 months to register with the MHRA (until
• Class III medical devices 30 April 2021)
• Class IIb implantable medical devices
• IVD List A

• Class IIb non-implantable medical devices 8 months to register with the MHRA (until
• Class IIa medical devices 31 August 2021)
• IVD List B
• Self-test IVDs

• Class I medical devices 12 months to register with the MHRA

• General IVDs (until 31 December 2021)
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Labels

Easy Medical Device

125 Deangate
Manchester, UK
M3 2LH

0123
S4M EUROPE
59 Rue Castellion
01100 Oyonnax

©Copyright 2020 Easy Medical Device GmbH

 UK
Manufacturer 15

EU NB Manufacturer

Importer
Importer ?
EAR

End Northern Ireland

Distributor -
User

© 2020 Easy Medical Device GmbH – Monir El Azzouzi

 EU
Manufacturer 16
Manufacturer

UK Approved
Body

End
-
Importer
User ?
Importer

Northern Ireland
End UK
Distributor -
Rep
User

If UK Approved
Accepted until Body
June 30th, 2023
© 2020 Easy Medical Device GmbH – Monir El Azzouzi
 Anindya Mookerjea 17
Managing Director/UK Responsible Person

Phone: +44 161 543 6588

Mobile: +44 745 915 3907

Address: 125 Deansgate, Manchester, UK M3 2LH

Email: amookerjea@easymedicaldevice.com

©Copyright 2020 Easy Medical Device GmbH

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SWIXIT

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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

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Swiss votation

 Votation to say Yes or

No to free movement of
people coming from the
European Union

Result: YES

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MRA negotiation

 Negotiation in progress
 If MRA signed before May 26th, 2021
 If MRA signed after May 26th, 2021

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Manufacturer

Importer
EAR Swiss will accept
CE marked Products
End-
User

Distributor

©Copyright 2020 Easy Medical Device GmbH

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TURKXIT

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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

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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

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Notified Bodies for MDD

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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

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Summary

©Copyright 2020 Easy Medical Device GmbH

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Manufacturer

Importer
EAR

End
-
User
EU Notified
Body
Distributor

© 2020 Easy Medical Device GmbH – Monir El Azzouzi

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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