Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2023

Baroness Merron Excerpts

Tuesday 6th February 2024 Grand Committee

Just to return to my opening remarks, I am somewhat concerned, and I think we should all be concerned, about, over the years, the size of the body of law we are going to build up for really quite small regulatory matters. Particularly if we end up, frankly, with our device and the EU standards being identical, we will end up with a large body of law to do very little. I know it is not something the Minister can control, but I feel it is worth putting on the record each time we come across a statutory instrument in this area.

[Baroness Merron (Lab)]

My Lords, I also thank the Minister for setting out the provisions in the regulations and for trying to unravel the many pages before us. This seems to be one of those innocuous measures that are needed just because that is where we are, but I very much take on board the comments of the noble Lord, Lord Allan, which are worth wider government consideration.

Clearly, these regulations are needed to support the implementation of new EU regulations that came into operation in Northern Ireland in May last year. They are important in that we have to secure continuity of supply and trade in medical devices within the UK and the EU, and the draft regulations affect a diverse range of equipment and systems to examine specimens in vitro, including items such as blood grouping reagents, pregnancy test kits and hepatitis B test kits, to give just a few examples.

As the noble Baroness, Lady Finlay, said, it is important that we support innovation. The medtech sector provides a huge contribution to our health service and our vibrant life sciences sector, from catching killer diseases early all the way through to preventing infections. The products we are talking about are found in doctors’ surgeries, hospitals and our own homes. They are part of our daily lives. We certainly know from the pandemic how difficult it can be to replace them if supply is disrupted, so we are here to ensure that supply disruption does not happen.

As has been said, the Explanatory Memorandum sets out that these regulations should affect only some 19 businesses in Northern Ireland and cost less than £5 million to implement, but it is important to acknowledge and put on record that they are a valuable part of the UK medtech ecosystem. On these Benches, we certainly support the regulations, which we believe will secure unfettered access to the British market for Northern Ireland businesses and ensure continuity of supply.

I also have a few questions that I hope will be helpful for the Minister. It is welcome that the previous fee structure is being retained to reduce disruption for Northern Ireland operators, but could he say what assessment has been made of any impact on the MHRA’s responsibilities as a regulator? Could he also confirm that it will be resourced to fulfil those responsibilities?

Previously, Ministers have talked about future realignment of regulations on medical devices following our departure from the EU, including consideration of alternate routes to the British market. Can the Minister say a bit more about what opportunities there might be in this area? What is the timeline for the future regulatory regime that the Government want to bring into force? As the Government have not yet set out their proposals, is there a timeline for doing so?

I note that medical devices did not receive attention in the Windsor deal, which was understandably disappointing to some suppliers, which cited the complexity of navigating the current system. Is the Minister considering adding other product classes, such as other devices, to its scope? Will he also clarify the status of devices on which a conformity assessment has been performed by a UK notified body? Following on from the questions from the noble Lord, Lord Allan, in this regard, will it be possible to place devices bearing a “CE” conformity mark, as well as the EU Northern Ireland mark, on to the EU market? Is it the case that no UK notified body has been appointed? If that is the case, when will this be dealt with and what is the delay down to?

In summary, we are pleased to support these amendments to the regulations to secure continuity of supply for the critical medtech sector. I look forward to hearing the Minister’s response.

[Lord Markham (Con)]

I thank noble Lords for their contributions and the spirit in which they were made in terms of helpfulness and trying to make the market as open and productive as possible.

I shall try to answer the questions in turn. To the noble Baroness, Lady Finlay, I say, yes, this is part of the four SIs.

On the noble Baroness’s whole question about making the UK market attractive to innovation, that is exactly what this is all about. On her point about clinical trials, my understanding is that there was a period when we slipped down the league on timings. I am told that a lot of that was because we were trying to prioritise Covid issues but, as I understand it today, we are now back within the timeframes. While we slipped down to 10th place in the league, the understanding from recent business coming in is that we think that we are making our way back up into the champions league spots, for want of a better phrase. I am assured that we have seen quite an improvement in the time taken in clinical trials.

On the noble Baroness’s question about what this means for the MHRA—the noble Baroness, Lady Merron, asked a similar question—we do not believe that this should have a significant impact. At the same time, I am totally with the sentiment that we do not want the MHRA to be a bottleneck, not just in this area but generally because speed to market is important here. In the last Budget, we agreed quite an increase in the MHRA’s budget, exactly so that it is able to pass such things through more quickly.

On the points about mutual recognition, it is absolutely our direction of travel. We are looking to do that with other authorities. Again—this also goes to the question of the noble Lord, Lord Allan—we are recognising the “CE” marks until 2030. That is probably a good example of mutual recognition.