The positive first step on UK medical device and IVD regulation

Ashleigh Batchen, regulatory affairs manager of BIVDA, follows up from an episode of The MedTalk Podcast, following the MHRA’s published consultation on the future of medical device regulation and in vitro diagnostics in the UK. 

During our conversation on the MedTalk Podcast you said the MHRA’s published consultation was a really positive step, which bits in particular pleased you about what was said? 

It seems like MHRA have really listened to their stakeholders and have softened (or completely removed) certain aspects they had initially planned. For example, continued recognition of the CE mark is hugely positive and allows industry to continue to place a product on the UK market for a specific period of time. This is not only positive for industry, but also for patients who will still have access to the devices they need. Initially due to the political need to diverge from the EU as much as possible, I wasn’t sure if we would get any kind of continued recognition. 

You said this is an opportunity to build a world class regulatory system for the UK and for the UK needs. There might be a lot of aspects to this, but what does that look like in your view?  

It looks like a practical, robust, and UK-patient-focussed regulatory system. What I mean by that, is the remaining EU member states all have different patient needs and healthcare systems in comparison to the UK. We now have the opportunity to shape UK regulation to be exactly what is needed within the UK healthcare system and amend specific items that are not included within the EU system. One of the important areas where this would apply is in relation to adoption into the NHS, which is a more centralised process than is typical in the EU and comes with its own hurdles. This isn’t discussed in the consultation response, but it is an area that could benefit from some kind of innovation pathway. 

It looks like there is going to be a lot of alignment with the EU – what changes specific for the UK do you expect or would like to see? 

MHRA have already said they are planning on removing a whole conformity assessment route for IVDs. This is mostly because it’s very rarely utilised, but it does mean that manufacturers would have an easier process of deciding which route to go down. As well as this, classification will probably be different from the EU IVDR, with genetic testing and companion diagnostics having a more risk-based approach (and therefore likely falling into class C or class B). 

Hopefully, we will have better links to other global markets and re-establish the UK as a leading regulatory space – something which I think has taken a bit of a dent recently. 

What needs do in-vitro diagnostics manufacturers have that medical device manufacturers may not have, and vice-versa, in the design of this regulation? 

Fundamentally, IVDs and general medical devices are quite different and therefore need to be regulated differently. For example, biocompatibility isn’t as much of a concern for IVDs as they typically aren’t coming into contact with patients (but are with patient samples so this needs to be considered!), and ‘IVD implantable’ is an oxymoron; there is no need for implant cards or the associated risks that come with being implanted. 

On the other hand, the range of general medical devices is arguably far more vast. Millions of medical devices exist on the market spanning an incredible range of indications, whereas IVDs are generally more specific and relate exclusively to diagnostics. That means the regulation for IVDs can be more detailed and focussed, while general medical devices need to make sure it is encompassing all the variation in possibilities. 

When it comes to the prospect of regulation becoming too burdensome, you mentioned the need for it to be realistic – what does a realistic UKCA mark medical device regulation look like? 

It has to be reasonable in how long it would actually take organisations to implement, including being at a suitable level for the existing resource. There is already a global shortage of regulatory professionals and companies will struggle to find more headcount if that is required. The other main aspect is cost-driven: ultimately, if it costs more than the product is likely to gain back, then it’s not feasible to stay on the UK market. 

The most logical approach would be to continue to recognise the CE mark in the UK indefinitely, and not require any additional resource or cost on top of that, however that seems very unlikely. 

Anything else that you would like to add?

It’s important to remember that all organisations are in the same boat when it comes to UKCA: no-one has clarity on what is to come, no-one knows where to start, and timing is short for everyone. On Friday 21 October, MHRA announced an extra 12 months to the existing standstill period, meaning that the current situation continues to apply until July 2024. This gives some breathing room for industry, but it’s still crucial that we get the legal text as soon as possible.