29 November 2017
When the clock strikes 23:00 on 29 March 2019, all directly applicable EU law will be copied and pasted (with some amendments) into UK law (assuming this date is exit day). With one stroke of the legislator’s pen, an entire parallel corpus of law will be cloned and cross the channel.
No one has ever described this process contained in the Withdrawal (European Union) Bill as particularly elegant or subtle – really, the process raises more questions than it answers. One of the more pressing questions is how EU Regulations coming into force in phases over the transition period will factor into this great migration. The Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) are two such Regulations stuck in this Brexit limbo. So, what’s going to happen to the MDR and IVDR after 23:00 on 29 March 2019?
If we are to meet the Grand Challenges outlined today in HM Government’s Industrial Strategy, medical devices require attention. In 2016, UK life science exports totalled £30.7bn, this contribution accounting for 11.4% of all manufactured goods. £4.9bn of these exports were medical devices (excluding IVDs). The combined contribution of MDs and IVDs therefore represents a major supporting pillar of the UK life science sector.
The UK Life Sciences Industrial Strategy notes that Germany, US, Switzerland, Ireland, and Singapore have all prioritised investment in their life science sectors. Reports that paint a bleak picture of post-Brexit UK influence in medical products, vaccines and technology are therefore particularly troubling.
Moreover, this growing sector (£4.5bn in 2015 to £4.9bn in 2016) exists in a highly competitive context. The UK Life Sciences Industrial Strategy notes that Germany, US, Switzerland, Ireland, and Singapore have all prioritised investment in their life science sectors. Reports that paint a bleak picture of post-Brexit UK influence in medical products, vaccines and technology are therefore particularly troubling. The nature of the competition dictates that a sector standing still is one that is falling behind. Hence, the thought of diminishing influence represents an urgent threat to the Life Sciences as a whole. These economic considerations should also be paired with the even more troubling thought that some medical products are not covered by WTO rules, and so their importation may be disrupted if a bespoke deal or soft Brexit remains unsecured. Accordingly, regulatory uncertainty is the last thing a sector under pressure and an NHS that requires robust procurement need.
Medical devices were wholly regulated by a set of Directives: the Medical Devices Directive, the Active Implantable Medical Devices Directive, and the In Vitro Diagnostic Medical Devices Directive. On 5 April 2017, the EU Commission published the MDR and IVDR. The MDR and IVDR are intended to do the job of the previous three Directives. These pieces of law set the safety standards necessary to obtain a CE mark and so sell medical devices within the European Economic Area. Regulations (unlike Directives) are directly applicable and do not require parallel national legislation to have effect in that Member State. So, what’s the issue?
Why not just convert the MDR and IVDR into UK law on 29 March like all other Regulations? Well, the MDR and IVDR are directly applicable law in the UK now. However, different articles of the Regulations have various dates of application. In short, the Regulations come into force in phases. It just so happens that these bits fall awkwardly between now and 2022, that is, both before and (unless there is a huge delay) after Brexit. So, on 26 November 2017, the articles regarding the regulation of Notified Bodies came into force. On 26 May 2018, the articles on cooperation of competent authorities will then apply. However, on exit night, the real meat of the MDR and IVDR will yet to be in force, these sections apply in May 2020 and May 2022, respectively. The Withdrawal Bill proposes to take a snapshot of all law currently in force at 22:59 on 29 March. This explicitly excludes these 2020 and 2022 provisions. Taking the Bill at its word then, the MDR/IVDR will both be and not be transcribed into UK law.
This uncertainty is especially problematic for prudent companies wishing to be prepare for the MDR/IVDR now and those seeking to certify a new product to market. Art 120(5) MDR and Art 110(5) IVDR tell us that companies can certify their medical devices according to the new Regulations ahead of their 2020/22 deadlines. Given the massive jump in scope and evidence required to certify from the Directives to the MDR/IVDR, wise companies should be preparing for MDR/IVDR implementation yesterday. But, how can these companies embark upon this complex and rather expensive task with such uncertainty?
The Withdrawal Bill proposes to take a snapshot of all law currently in force at 11.59 on 29 March. This explicitly excludes these 2020 and 2022 provisions. Taking the Bill at its word then, the MDR/IVDR will both be and not be transcribed into UK law.
Some attempts have been made to provide certainty. The Under-Secretary for the Department of Health and the MHRA have both given assurances that the UK will follow the MDR and IVDR. However, the advice from the former seems to miss the nuances of implementation periods and the Withdrawal Bill, Lord O’Shaughnessy has said:
“Elements of the new regulations have been applied directly in UK law since May, meaning devices can now be legally placed on the market if they are in conformity with the new regulations… As it stands, the EU (Withdrawal) Bill would maintain this position beyond March 2019”
While these assurances are most welcome, it is important that further clarity is provided for the 2020 and 2022 provisions not covered by the Withdrawal Bill. It is this uncertainty that is likely to hamper efforts to comply with the MDR/IVDR and sell to Europe. It is these articles that call into question how medical devices will be regulated post-Brexit.
In a nutshell, recognition and explicit assurances need to be given regarding the articles of the MDR/IVDR not covered by the Withdrawal Bill. Lord O’Shaughnessy’s comments are a good start. It is hoped that his peers echo and provide further details before MDR/IVDR compliance begins in earnest. After all, hell is truth seen too late.
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