The new UK MDR draws near, and we’re all still clueless about the rules


As the end of March draws near, it has been almost four months since the close of the MHRA’s consultation on future amendments to the United Kingdom’s Medical Devices Regulations 2002 (UK MDR), and the outcome of that consultation has not yet been published.

We had hoped to see the outcome of the consultation by now, as we are acutely aware of the fact that the planned amendments to the UK MDR are supposed to come into force on 1 July 2023 (16 or so months away), and we still do not know exactly what the rules are going to be.

We understand that part of the reason for the delay is the Trade and Cooperation Agreement signed by the UK and the European Union following Brexit. Under that agreement, the UK government is obliged to notify proposed regulatory changes such as the planned amendments to the UK MDR to the World Trade Organisation. The EU must then be given 60 days to provide comments and there may also be further discussion of the proposals between the UK and the EU.[1]

Based on the terms of the consultation itself, we expect that the eventually resulting legislation will broadly harmonise the UK MDR with the EU’s own recently revamped medical device regulatory framework.[2] However, we still wait for the outcome of the consultation with bated breath, as the specifics will determine how straightforward the UK’s transition to its new regulatory framework for medical devices will be.

One area to which we will pay particular attention is the transitional periods. When the UK MDR amendments come into force in 2023, it is extremely unlikely that all medical devices in the UK will need to immediately undergo a new conformity assessment to continue to be commercialised. The terms of the consultation indicate that the UK intends to follow the EU’s example by allowing devices which were conformity assessed under the old framework to continue to be placed on the market for a period of time once the new framework comes into force.

The critical thing is going to be the length of these transitional periods. Very short transitional periods will mean a very jarring transition, as every manufacturer scrambles to obtain a conformity assessment as quickly as possible at a time when capacity to conduct conformity assessments is extremely limited. The UK currently only has three notified bodies (or “Authorised Bodies”, as they are now referred to in the UK) to conduct conformity assessments and award UKCA marks under its post-Brexit regulatory framework. That’s really not a lot, given that manufacturers of medical devices for supply in the UK could previously rely on the EU’s complement of more than fifty notified bodies to conduct conformity assessments and award CE marks.

Either the UK needs to urgently find a way to boost Approved Body capacity, or long transitional periods are going to be needed to allow three organisations to do the work of fifty. The alternative is that lifesaving medical devices have to come off the market because they cannot undergo conformity assessment in time, which would be disastrous for patient care. Influential figures in Europe are already warning that the EU is facing such a scenario as it transitions to its new regulatory framework and are calling for urgent action. It would be extremely embarrassing for the UK to have the opportunity to learn from the EU’s mistakes and to go ahead and make the same mistakes anyway.

Very long transitional periods should help to avoid that sort of conformity assessment capacity crunch, as new Approved Bodies will have more time to come online and manufacturers will be able to take a little more time to obtain new conformity assessments. However, we do recognise that that might also lead to some complacency and then a last minute rush from some manufacturers as the transitional periods draw to a close. Clearly long transitional periods are preferable from a patient safety perspective, but there is probably a happy medium to be found.

We look forward to seeing which way the UK has decided to jump. Hopefully it can learn from the EU’s mistakes: one cannot impose onerous regulations without simultaneously investing heavily in the necessary infrastructure to implement them (such as Approved Bodies), and then expect industry to adapt to the new regulations at pace.

[1] Article 94, Trade and Cooperation Agreement between the European Union and the United Kingdom of Great Britain and Northern Ireland
[2] Which consists of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).