Brexit Contingency Action Plan Issued by European Commission
Regulatory Updates | Medical Devices
EMERGO BY UL SUMMARY OF KEY POINTS:
- The European Commission has published its emergency plan for Brexit.
- The focus of this plan is to safeguard the interests of European citizens and UK citizens currently living in the EU27.
- Plans are defined on a high level; there is nothing specific on medical devices.
The UK has voted in a referendum to leave the European Union (EU). The procedure, described in article 50 of the Treaty of the European Union, started on March 30, 2017 and should take two years at a maximum. With less than 100 days to go and the UK Parliament not voting on the withdrawal agreement, it has become more likely that the UK will leave the EU without an agreement. This will result in a "no-deal" or “cliff-edge” Brexit. If that happens there will an abrupt end to the Single Market relation between the UK and the EU, which would have serious consequences.
The European Commission published its Brexit Contingency Action Plan on December 19, 2018. This plan follows up on the Communication that has been published on November 13, 2018. As part of this step the majority of the implementing acts announced in the November 13 Communication have now become applicable. In order to see all this work out as intended, Member States are requested to follow up on these specific acts and should not engage in bilateral agreements with the UK.
When Member States implement any measure, they should observe specific objectives. These measures are intended to provide a sort of airbag for the Brexit situation. But this cushion should not be soft enough for Brexiteers to consider that a reason to go for a cliff-edge Brexit. For example, measures should not replicate the benefits of EU membership or the terms of the transitional terms of the Withdrawal Agreement and they should be temporarily. Of course they should also be in line with EU policies and legislation and where possible they have a specific timeline after which they are no longer applicable.
One exception will be made for UK citizens living in the EU. Although these people would suddenly become third country citizens, the EU has asked Member States to take a “generous approach.” These people should remain legal residents in the Member States where they reside.
Financial services will also be impacted, although these effects can probably be contained. This means the City of London can keep functioning longer for the EU as a financial center, although measures appear to have an ending date. Therefore all parties involved should take steps to mitigate risks. This also means that all involved should evaluate if their service providers will remain under EU law, and if not, what that the consequences of that would be.
Air traffic will remain possible, but there are some restrictions in terms of timelines. These measures will probably be adapted further during 2019.
Operators of road haulage will remain capable of operating in the EU until the end of 2019. After that deadline, new agreement should be installed.
Member States have to levy duties on goods imported from the UK from Brexit day. Measures will be taken to allow for pre-departure declarations in order to enable smoother transactions at the border.
More steps will follow over the coming weeks. In the meanwhile the UK can still decide to adopt the Withdrawal Agreement, or cancel Brexit in total.
Nothing specific has been mentioned on medical devices. The earlier plans do not go into the specifics of the sector, although there are particular measures mentioned for medicinal products. The main difference is probably due to the fact that medicines fall under DG SANTE while medical devices are covered by DG GROW. This could likely mean that serious delays at ports after Brexit day will result in shortages of medical devices. Most problems will happen in the UK, but we may also see shortages in the EU27.
Related UK and European medical device regulatory information:
- European CE Marking consulting for medical device companies
- EU MDR gap assessment and CE Mark transition strategy
- European Authorized Representative in-country representation
- Webinar: How to select or change your Notified Body