Speaking of surprises – this was a big one. I do not want to use this blog for political statements, so I won’t bore you with my personal opinion on whether this was a good idea first from the country’s leaders and secondly from the country’s citizens. That’s all moot now anyway, and time will tell. Like always in law and regulation we will work with the tools that the powers that be make available to us.
First, it may not happen at all. The UK is still in discussion with itself about whether this referendum is final. There are already initiatives for another referendum that should produce a more decisive difference between stay and leave votes (it now was 48.1% stay 51.9 % leave).
Secondly, it is not sure yet if the whole UK leaves.The Brexit may not involve the entire UK, as Scotland is already publicly coining the option of not leaving the EU but divest from the UK instead and remain EU member state.
The first questions are starting to arrive in my inbox about what this means for CE marks for medical devices and for the process of the MDR and IVDR as well as medical devices law and policy in the EU in general, so here is my view on that.
The situation of a Brexit is unique, so we will need to see what happens as no other member state ever decided to divest from the EU or its predecessors. The provisions in the EU Treaty are not very precise on what exactly happens now and there is no precedent. The procedure is that the UK will now enter into negotiations with the EU about divestiture from the EU and has two years for that process. In that process instruments of the EU internal market (of which medical devices policy is a subject) may be replaced by treaties, much like the mutual recognition agreement that Switzerland has with the EU and that covers, among a lot of other subjects, medical devices. That agreement allows Switzerland to have notified bodies and provides for mutual recognition of the CE mark in Switzerland.
My best guess is that the situation between the EU and UK will come to look very much like that between Switzerland and the EU, because I do not expect the UK to settle for EEA membership (as sort of EU light, which allows for example Norway to have notified bodies and have mutual recognition). EEA membership means automatic implementation of most EU law with none of the influence of a member state in its legislative process. A Swiss type arrangement is a realistic scenario: UK notified body BSI issued a statement along these lines for example. Theoretically the UK could also enter into a customs union with the EU, like Turkey, and that instrument might provide a basis for mutual recognition – but this kind of deal seems reserved for countries that are aspiring EU members.
What the transitional regime would turn out to be is impossible to predict at this stage, but it will probably involve grandfathering, which in turn is influenced by the transitional regime for the MDR and IVDR.
MDR and IVDR impacted?
One of the questions I received was whether the Brexit would impact the MDR and IVDR.
The EU will certainly not suspend the MDR and IVDR project because of the Brexit because the texts were established following the normal legislative procedure. The texts will enter into force in the EU as planned and may also take effect even in the UK, up until the date on when the UK formally disengages from EU law having direct effect in its jurisdiction. They will in any event enter into force in the EU’s 27 member states.
What medical devices law will apply in the UK will depend on where the UK goes. It cannot afford to close itself off of the EU market so it will aim for mutual recognition. The question is when that enters into force, but it will have to be somewhere between now and two years from now.
How will this affect you as a company?
Should you ditch your UK notified body now? As quoted above, BSI thinks that it will remain notified – but there are no guarantees. It would be unlikely that the UK would not not retain a notified body, but it was also unlikely that the UK would leave in the first place. It will depend on the deal that the UK negotiates with the EU.
Should you have an authorized representative or manufacturer in the UK? That, too, will depend on the deal that the UK reaches with the EU. Assuming that mutual recognition will be agreed upon, your devices could still benefit from access to the EU market.
If the deal with the EU is bad, some of the historic trade barriers may come back. If it’s good, the UK may become a sort of Switzerland for the purposes of medical device law. That’s basically all I can say at the moment.