EMERGO SUMMARY OF KEY POINTS:

• A draft agreement on Brexit has been struck between EU and UK negotiators.
• Notified Bodies will remain recognized during the transition period.
• It is not certain this agreement will be accepted; a cliff-edge Brexit remains a possibility.

British and European negotiators have reached a draft agreement concerning the withdrawal of the United Kingdom from the European Union (EU).

Effects for validity of CE Mark certifications and Notified Bodies

The 585-page document outlines the UK’s transition from its current EU membership to full withdrawal. This transition starts on March 29, 2019 and ends on December 31, 2020. Article 127 on page 196 of the draft agreement clearly states that European Union Law will remain applicable during this transition period. This means that the placing on the market of medical devices may continue uninterrupted on both sides of the English Channel. It also means that Notified Body certificates will remain valid. It is not clear what will happen after that, because a new agreement must be drawn up regarding the relationship between the EU and the UK after the end of the transition period.

However, this is a draft agreement. It has been accepted by the British government, although several ministers have since decided to resign. It also needs to be accepted by the EU Member States, and an EU summit appears to be planned for November 25, 2018. The European Parliament as well as the British Parliament must also accept the agreement (a particularly unlikely prospect on the UK side).

Outlook far from certain

So it is far from certain that this draft agreement will become a reality. However, with the March 2019 deadline approaching there is not much time left for any change in that agreement. Thus, medical device companies need to prepare for Brexit: soft, hard or cliff-edge.
Several scenarios are possible:

1. Prime Minister May is voted out by her party and a new prime minister will have to do take up negotiations. It is unlikely a new prime minister will reach an agreement within the short timeframe remaining. This may result in the EU unilaterally starting preparations for a Cliff-Edge Brexit.
2. Prime Minister May remains in place and gets this draft agreement through Parliament. That would allow for a smooth transition.
3. Prime Minister May remains in place and confronts Parliament with a new referendum. This could have three results:
   
   1. The draft agreement is accepted;
   2. UK voters prefer a Cliff-Edge Brexit;
   3. UK voters vote “Remain” and the UK remains in the EU.

In short, this means that is far from clear what will happen in March 2019. A Cliff-Edge Brexit, a transition period or no Brexit at all remain real possibilities. Therefore industry should still prepare for a Cliff-Edge Brexit.

Additional European medical device regulatory resources:

• European CE Marking strategy for medical device companies
• European CE Marking consulting for IVD manufacturers
• European Authorized Representative in-country representation
• Webinar: How to select or change your Notified Body
• Whitepaper: Understanding Europe’s Medical Devices Regulation (MDR)