My Lords, I am glad to be able to take part in this debate, which allows the House to have a preliminary discussion about the future of medical devices regulation. I certainly welcome the establishment of an advisory committee, but I also welcome my noble friend’s amendment which makes sure that the rather tentative “may” is replaced by “must”. The Minister’s amendment is rather open-ended. It does not specify what matters it will advise the Secretary of State on, nor does it give any indication of the likely balance of membership. This is important because, as I have said, there has been some concern over quite a few years that the regulation of medical devices is not up to the mark, nor sufficiently protective of patient safety. The report by the noble Baroness, Lady Cumberlege, has identified some weaknesses. In that regard, I declare my interest as president of GS1 UK, the bar-coding association.
We received a very helpful briefing from Professor Muireann Quigley and colleagues at the University of Birmingham, pointing to the rather confused state that medical devices regulation is in. The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 came into force at the end of the EU exit transition period. These amend the Medical Devices Regulations 2002 to mirror key elements contained in EU regulations 2017/745, on medical devices, and 2017/746 on in vitro diagnostic medical devices. The aim of that was to make sure that there was good regulatory alignment between the UK and EU, as well as between different parts of the UK’s own regulatory framework. This Bill, when enacted, will provide an opportunity to mandate a more streamlined legislative approach. That would benefit all stakeholders, including industry, businesses and patients.
At present, the MHRA has no involvement in the pre-market phase of medical device development and there is a question as to whether it ought to have. Birmingham University colleagues are certainly proposing a proactive regulatory role for devices that is more akin to that for medicines. This would be clinically focused and, as they say, at least as stringent as the new EU medical devices regulations. Under that proposal, manufacturers could be required to apply to the MHRA before marketing their device. The MHRA could also assess the application in a way that is proportionate to the risks. It is proposed to take account of relevant factors, such as evidence-based supply, approvals in other jurisdictions and post-marketing surveillance plans. I know that that view may not necessarily be shared by industry, which would, perhaps, be concerned
about the cost and delay in achieving licensing. However, we can expect a pretty intense debate about medical device regulation in the future.
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There is also a need to reflect an industry fear that, for instance, once it becomes mandatory to use a UK process for the British market, suppliers may choose either to deprioritise Britain as a whole or else not to produce products here at all. One of the challenges is therefore to ensure that the UK remains attractive and that new sovereign regulation does not become merely duplicative and costly. Given the innovation in our own sector, this is very important indeed. The global reputation of the MHRA is clearly in our favour, as is the trend to the harmonisation of standards globally. However, we will also need to think about innovative regulation in areas such as digital healthcare, artificial intelligence and deep learning. I therefore assume and hope that the advisory committee will be very much involved in all that. That means that its membership must have a broad range of interests, including patients and users as well as industry. I hope that in winding the Minister may be able to say something about that.
The amendments in the name of my noble friend Lady Wheeler seek to create greater certainty by substituting “must” for “may”. Surely that is right, and I certainly support her on that.