26 mai 2020
As the entire medtech sector has been keenly aware since the EU Medical Devices Regulation 2017/715 (MDR) was adopted on 5 April 2017, the original three year transition period was expected to end on 25 May 2020. Full implementation of the MDR was due from 26 May 2020.
Medical device companies have been lobbying the European Commission for some time to extend this deadline. For devices already on the market, certain changes in classification and restrictions on the ability to continue to rely on certificates of conformity issued under the previous regime – the Medical Device Directive 94/32/EEC and the Active Implantable Medical Device Directive 90/385/EEC – have increased the volume of requests for conformity assessment under the MDR.
At the same time, delays by the Commission and national regulators in the process of designating Notified Bodies to carry out conformity assessment under the MDR have led to capacity constraints and severe delays for manufacturers.
Until the COVID-19 crisis, the European Commission held its ground, refusing to accede to the requests to delay implementation.
Once the COVID-19 crisis struck, the European Commission quickly gave way. It proposed a one year extension of the implementation date. The rationale for the proposed delay was that the Commission wants to avoid causing disruption or placing an additional burden on medical device manufacturers during the global healthcare emergency.
The EU Parliament and Council have approved the EU Commission's proposal, so the new implementation date for the MDR is now 26 May 2021.
The original Brexit legislation, the EU (Withdrawal) Act 2018, provides that the UK will leave the EU at 11pm on 31 January 2020 (Exit Day) and, among other things, preserves in UK law following Exit Day all EU regulations as they took effect as of that date (retained EU law).
The provisions of the MDR which were only expressed to take effect on 26 May 2020 would not fall within the definition of "retained EU law" and hence would not form part of UK law after Exit Day (subject to any Withdrawal Agreement between the UK and EU-27).
Consistent with this, the UK Government's no-deal planning in Q3-4 2019 included publishing an extensive draft statutory instrument, the Medical Devices (Amendment etc) (EU exit) Regulations 2019. This was intended to amend the UK Medical Devices Regulations 2002 (which give effect to the existing EU medical device regime in UK law). This would have aligned UK law with the MDR with effect from 26 May 2020, which was a policy decision of the UK Government in the event of a no deal.
It is questionable whether the EU (Withdrawal) Act 2018 would have provided sufficient legal basis for the proposed statutory instrument, as the power to enact delegated legislation under that Act was limited only to making amendments to retained EU law required by virtue of the UK's exit. However, this point became moot once the UK-EU Withdrawal Agreement was concluded, as no-deal preparations fell away.
The UK-EU Withdrawal Agreement was implemented in UK law, a few days before Exit Day, by the EU (Withdrawal Agreement) Act 2020. This statute made certain amendments to the EU (Withdrawal) Act 2018 to implement the so-called "Brexit implementation period" or "Brexit transition period" agreed between the UK and EU, which runs until 31 December 2020.
In particular, it preserved section 2(1) of the European Communities Act 1972 for the duration of the transition period and postponed the cut-off date for "retained EU law" to 31 December 2020. This was the mechanism by which the MDR would have taken effect in the UK from 26 May 2020 before the COVID-19 postponement (presumably a statutory instrument repealing the Medical Devices Regulations 2002 would have been adopted under s2(2) of the European Communities Act 1972, which was also preserved).
Now that the EU has delayed the go-live date for the MDR from 26 May 2020 to 26 May 2021, this means that the MDR will no longer form part of retained EU law and so will not take effect in the UK by virtue of EU (Withdrawal) Act 2018 (as amended by the EU (Withdrawal Agreement) Act 2020).
Unless the UK Government changes its previous policy decision of aligning the UK medical device regime with the MDR, we therefore expect that a statutory instrument looking very similar to the draft statutory instrument prepared for a no-deal scenario will be adopted in Q1 2021, in order to align UK law with the new MDR regime.
Interestingly, a new Medicines and Medical Devices Bill has been laid before Parliament which contains powers to amend the UK Medical Devices Regulations 2002 following the end of the withdrawal period (curing the potential vires issue with the previous draft SI).
It is clear that the decision by the EU Parliament and Council to postpone the MDR implementation date beyond the end of the Brexit transition period will have significant implementations for the UK's legal framework for medical device regulation after Brexit.
One further point on timing should be considered. There has been some pressure on the UK Government and the EU to extend the Brexit withdrawal period due to the COVID-19 crisis, in order to provide enough time for the UK's future relationship with the EU to be properly negotiated.
The EU-UK Withdrawal Agreement provides that the Brexit transition period can be extended by up to 2 years (ie until 31 December 2022), if signed-off by the joint UK-EU Joint Committee by 1 July 2020. Any extension beyond 26 May 2021 would bring the MDR back within the definition of "retained EU law" and the position would be the same as before the COVID-19 postpone of MDR implementation.
Of course, the UK has legislated in the EU (Withdrawal Agreement) Act 2020 against any extension of the Brexit transition period, so any extension would require an Act of Parliament on the UK side. Furthermore, in a session of Prime Minister's Questions shortly before the UK entered lockdown in March 2020, Boris Johnson rejected calls for the Brexit transition period to be extended as a result of COVID-19.
However, this was several weeks before the COVID-19 crisis truly unfolded. Given the extraordinary twists and turns of the Brexit process to date, few will believe that this will be the last word on the topic.