March 19th the Taskforce on Article 50 negotiations with the United Kingdom published the “Draft Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community” along with a press statement by Michel Barnier following the latest round of Article 50 negotiations.
During the negotiations in March the UK and EU reached a conditional agreement on the transition period of Brexit. The transition period would run for a limited time, 21 months, from March 29th, 2019, the date of Brexit, till December 31st, 2020.
During this period, the UK will no longer participate in the decision-making process of the EU, as it will no longer be a Member State as of March 30th, 2019. It will maintain nonetheless all the advantages and benefits of the Single Market, the Customs Union, and EU policies, and should therefore also respect all the EU’s rules, as if it were a Member State.
The proposed draft also includes the provision that devices placed on the market before December 31st, 2020 will be considered to have been lawfully placed on both the EU and UK market and that these products can thus continue to freely move between the UK and EU even after the transition deadline.
The transition period would provide extra time for the EU and UK to further negotiate their relationship. However today we do not yet know whether the EU’s medical device and IVD directives and/or the new MDR and IVDR will apply in UK law in future. Also, despite this positive evolution there is still the risk of a hard Brexit as the legal certainty on all points negotiated, including the transition, which forms part of the agreement, will only come with the ratification of the Withdrawal Agreement on both sides. Nothing is agreed until everything is agreed.
What does this mean to you?
Our careful interpretation is that the status quo will continue until December 31st, 2020, meaning that the EU rules will continue to apply to the UK until then end of the transition period. This would thus imply that the MDR and IVDR will at least be applicable until the end of the transition period and that the distribution of medical devices and IVDs between the UK and the EU can continue as today until December 31st, 2020.
During the transition period UK based Authorised Representative would continue to be recognised in the EU. Also, the UK based Notified Bodies would be able to function as normal during this transition period.
We however stress this is a careful interpretation as nothing is definite yet and thus the possibility of a hard Brexit remains. We continue to advise you to have contingency plans in place.
Don’t hesitate to contact us for more information or for support in CE marking your products.