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

Preet Kaur Gill Excerpts

Tuesday 16th January 2024 General Committees

[Preet Kaur Gill (Birmingham, Edgbaston) (Lab/Co-op)]

It is a pleasure to serve under your chairship, Dame Maria.

As the Minister set out, we are considering regulations that update legislation pertaining to in vitro diagnostic devices and make supplementary provisions for the EU IVDR in Northern Ireland. The SI appears to be an innocuous measure to support the implementation of new EU regulations that came into operation in Northern Ireland in May last year. Those will continue to be applied, per the annex to the Windsor framework, but with consequential amendments to other legislation, provisions for the fees for certificates and conformity assessment, and some practical provisions for the enforcement of the new regulations.

It is of course critical that we secure continuity of supply and trade in medical devices within the United Kingdom and with the EU. The draft regulations affect a diverse range of equipment and systems to examine specimens in vitro, including things like blood grouping reagents, pregnancy test kits and hepatitis B test kits. From catching killer diseases early to preventing infections, the medtech sector makes a huge contribution to our national health service and our vibrant life sciences sector. These products are found in doctors’ surgeries, hospitals and our own homes, and we saw during the pandemic how difficult it can be to replace them when supply is disrupted.

Although the explanatory memorandum sets out that the draft regulations should affect only 19 businesses in Northern Ireland and cost less than £5 million to implement, they are still a valued part of the UK medtech ecosystem. The Opposition therefore support the regulations to secure unfettered access to the GB market for NI businesses and continuity of supply. None the less, I have a few questions for the Minister.

We welcome the fact that the previous fee structure is being retained to reduce disruption for NI operators, but will the Minister say what assessment has been made of any impact on the MHRA’s responsibilities as regulator, and assure us that it will be resourced to fulfil them? Previously, Ministers have talked about future realignment of regulations on medical devices following our departure from the EU, including consideration of alternative routes to the GB market. Will the Minister comment on the opportunities in this area? What is the timeline for the future regulatory regime that the Government want to bring into force? The Government have still not set out their proposals; is there a timeline for doing so?

It is interesting that medical devices did not receive attention in the Windsor deal. I know that some suppliers are disappointed by this, citing the complexity of navigating the current system. Is the Minister considering adding other product classes, like medical 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? Will it be possible to place devices bearing a CE conformity mark as well as the EU(NI) mark on the EU market? To my knowledge, no UK notified body has been appointed; when will this be dealt with and why has it been delayed?

To reiterate, we support the amendments to secure continuity of supply for the critical medtech sector. I look forward to hearing the Minister’s response.