It's all a question of timing: Medical Devices, In Vitro Diagnostic Devices, EU Regulations, and Brexit
Thursday 13 July 2017 saw the publication of the so called "Great Repeal Bill" (GRB), which when enacted into UK law will deftly sweep EU laws (both directly and non-directly applicable) onto the UK statute book, and making them UK law rather than EU law.
Only three months earlier, on 5th April 2017, the EU published the long-awaited medical device regulations (MDR) and in vitro diagnostic regulations (IVDR). As regulations these will be directly effective in member states of the EU from the dates in which the different provisions come into force. However, the timetable for their application overlaps with the Brexit timetable and this is going to give the UK government something of a headache.
Under the GRB, European Directives which have been separately written into UK law, called "EU-derived domestic legislation", will continue in effect as part of UK law in the form it was in immediately before "exit day" ("E-Day"). This means that the three medical device directives (MDD, IVDD and AIMDD) will on 30 March 2019, continue to be part of UK legislation in the form they are written into UK law, even though they are an enactment of EU law. So far, so good!
For each of the European regulations, which are not separately written into UK law, because they have direct effect, these are each to be enacted directly into UK law "as it has effect in EU law immediately before" E-Day (and this is the important bit to remember). "As it has effect in EU law" is defined in Section 3(3) of the GRB as any law which must be "in force and applies immediately before exit day". The dates when most of the provisions of MDR and IVDR apply fall after E-day, so, unless the UK takes steps to separately enact the provisions of these two regulations into UK law, only the few provisions which are applicable in advance of E-day will ever become part of UK law.
This means that, unless the UK government takes steps to change the position, in the UK, medical devices and in vitro medical devices will remain regulated by what will in due course be seen as second-rate legislation. For UK medical device manufacturers, this will be a concern because UK-manufactured devices would risk having the same label applied to them.
Here is a diagram which illustrates the issue of timing:
I had the opportunity to point this out to Lord O'Shaughnessy, Parliamentary Under-Secretary (Department of Health), on Friday. At his request I have written to him explaining that medical device and in vitro diagnostics companies need the UK government to apply its attention sooner rather than later to determining precisely what legislation the UK government would want to regulate medical devices in the UK in the years to come. The alternative of just letting GRB and the Act which comes out of it to run its course will otherwise leave the UK industry in an uncertain and undesirable situation. More on this later….