Presentation by Simon Marks, Head of Hi-Tech practice, ERM Law Firm, about Brexit Update for MedTech, Feb 5, 2019. Includes Advantages of Doing Business in the UK, Brexit update, Timeline, What’s next? The Withdrawal Agreement, No Deal, Contingency Planning, Implications for Manufacturers and Importers

1. Brexit Update
mHealth | 5 February 2019

2. Contents
 Introduction
 Advantages of
Doing Business in
the UK
 Brexit update
• Timeline
• What’s next?
• The Withdrawal
Agreement
• No Deal
• Contingency Planning
Introduction
Simon Marks, partner
and joint head of
High-Tech & Start
Ups
Epstein Rosenblum
Maoz (ERM)

3.  Advantages of Doing Business in the UK
• Based on the World Bank Doing Business Survey 2018, the UK is ranked Second in Europe in terms of
ease of doing business, and Seventh in the world. It offers the following advantages:
 A deep pool of workforce expertise;
 Excellent transport links with the rest of the world;
 A central time zone position ideally placed between the markets of the East and West;
 Accessibility of language;
 A solid, credible and long-established structure for companies to build businesses;
 One of the world’s global-financial centres;
 A top-class environment for research and development work;
 Opportunity to raise capital through the UK markets, with access to international investors;
 Low corporation tax – currently 19%, reducing to 17% by 2020;
 A wide network of Tax Treaties;
 A familiar gateway into the rest of Europe and a member of the EU*.

4. Brexit - Timeline from Referendum to Brexit
• 23 June 2016 – UK public vote to leave the EU by 51.9% to 48.1%. David Cameron resigns immediately as prime
minister.
• 29 March 2017 – the UK government triggers Article 50 of Treaty of Lisbon, which starts the 2 year clock ticking
for the UK to leave the EU.
• 8 June 2017 – conservative party losses overall majority in UK general election.
• 26 June 2017 - formal negotiations begin between UK and EU.
• 19 March 2018 - UK and EU make decisive steps in negotiations. Agreements include dates for a transitional
period after Brexit day, the status of EU citizens in the UK before and after that time and fishing policy.
• 25 November 2018 – draft withdrawal agreement agreed with EU.
• 15 January 2019 – UK parliament votes against the withdrawal agreement by 230 votes.
• 29 March 2019* - Brexit day – the UK ends its membership of the EU and enters a transition period.
• 31 December 2020* - the transition period ends and the new economic and political relationship between the UK
and the EU begins.

5. • What Will Brexit Look Like?
There are currently several potential scenarios. Let’s focus on the
main ones:
1. Negotiated settlement with the EU - the Withdrawal Agreement;
2. No deal.
Other potential scenarios include, postponement, 2nd referendum,
general election*, etc.
All of the above except for “No Deal” require approval of UK
parliament.
Brexit – What’s next?

6. • Transition - transition period until 31 December 2020, which
can be extended until 2022.
• Money – financial settlement or "divorce bill" expected to be at
least £39bn.
• Citizens' rights - UK citizens in the EU, and EU citizens in the
UK, will retain their residency and social security rights after
Brexit. Citizens who take up residency in another EU country
during the transition period will be allowed to stay in that
country after the transition; anyone that stays in the same EU
country for five years will be allowed to apply for permanent
residence.
Withdrawal Agreement - Key Terms:

7. • Northern Ireland - If no long-term trade deal has been agreed by
the end of 2020 which avoids a hard border and no extension to the
transition period, then a backstop consisting of "a single customs
territory between the EU and the UK" will be triggered. The UK
cannot leave the backstop independently.
• Laws and disputes - The UK will remain under European Court of
Justice (ECJ) jurisdiction during the transition.
Statement on future relations: In addition to the withdrawal
agreement the parties agreed a 26-page statement on future relations.
It is not legally-binding and sketches out the kind of long-term
relationship the UK and EU want to have in a range of areas, including
trade, defence and security.

8. Brexit – No Deal
• No deal - what are the implications?
• the transition period from March 2019 to December 2020 - designed to give
businesses and organisations additional time to respond to the changes -
would be off the table;
• UK would be subject to World Trade Organization (WTO) rules meaning UK
exports would face the same customs checks and tariffs as other countries
outside of the EU;
• The rights of three million EU citizens residing in the UK and more than one
million Britons living in the EU would not be protected;
• Northern Ireland - if the UK were to leave without an agreement in place,
the Republic would come under huge pressure from Brussels to exert
customs and immigration controls, i.e. a hard border.

9. • UK Manufacturers and Importers and EU-based Distributors -The UK will be
considered a “third country”. At that time, EU operators who were previously
considered distributors will be considered importers and will have to adhere to all
obligations applicable to importers from third countries.
• Authorised Representatives - UK-based operators who wish to continue placing
specific devices on the European market, including medical devices and IVDs, will
need to designate an authorised representative established in the EU - a
requirement for all operators located outside of the EU. The new Medical Devices
Regulation (MDR) and the in vitro diagnostic Regulations (IVDR) introduce a new
requirement for manufacturers and European Authorised Representatives to have at
their disposal at least one qualified person responsible for regulatory compliance
who should be based in the EU.
• Non-recognition of UK - Notified Bodies - UK Notified Bodies will no longer be
considered EU Notified Bodies and all EC certificates issued by UK-based Notified
Bodies could be void as of 30 March 2019. Economic operators based outside of
the EU (including the UK) must ensure that they have valid certificates issued by an
EU-27 Notified Body before 30 March 2019 or risk being unable to continue offering
their products on the European market.
No Deal - Impact on Manufacturers and Importers of
Medical Devices

11. Truly cross-border