Draft Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2023
(11 months ago)
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The Chair
Before I call the Minister to move the motion, let me I make it clear to the Committee that this is not exclusively a Northern Ireland instrument, as items to which it refers can be sold in the rest of the UK. I will therefore allow this Committee to run for 90 minutes.
The Minister for Health and Secondary Care (Andrew Stephenson)
I beg to move,
That the Committee has considered the draft Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2023.
It is a pleasure to serve under your chairmanship, Dame Maria.
I will begin by setting out the policy context of the draft regulations. The Medicines and Healthcare products Regulatory Agency is the UK regulator for medical devices, including in vitro diagnostic devices. The agency is responsible for enforcing the regulations and protecting patient safety. The provisions in the instrument will enable the MHRA to carry out its duties effectively in Northern Ireland.
IVD devices are used to test samples taken from the human body, to monitor a person’s overall health or to treat and prevent diseases. These can include complex tests, such as blood tests to detect HIV or hepatitis and tests for cancer biomarkers, or more commonly used tests, such as pregnancy tests. In May 2022, the EU replaced its regulatory framework for IVD devices with a new regulation, the EU in vitro diagnostic regulation. The EU IVDR has automatically applied in Northern Ireland since 2022 under the terms of the Windsor framework.
This statutory instrument brings important benefits to patients and businesses across Northern Ireland. First, it enables the MHRA and the Department of Health and Social Care to protect patients in Northern Ireland more effectively. Without it, the MHRA will lack important powers equivalent to those in place across Great Britain, leaving NI patients lacking important safety protections available elsewhere.
Secondly, the SI is particularly important because life sciences and medical technology are major growth sectors for the Northern Irish economy. It provides for a stable regulatory environment in Northern Ireland, enabling the whole of the UK to remain an attractive market for research and the development of medical technologies. Thirdly, the SI will unblock UK-wide clinical studies of medical devices and IVD devices that include Northern Irish locations. Last, the SI facilitates consistency between the operation of devices regulation in Northern Ireland and GB where beneficial to Northern Ireland, including through provisions to charge comparable fees and to reflect the unfettered access of NI IVD devices into the GB market.
I will summarise the key provisions in the instrument. It lays down proportionate penalties and gives the MHRA powers to serve enforcement notices for breaches of the EU IVDR in Northern Ireland. Although the MHRA previously had the necessary tools to respond to safety concerns, the draft regulations further strengthen that toolkit. The SI also gives the MHRA powers to designate and monitor notified bodies in relation to the EU IVDR and charge fees relevant to those services. Notified bodies in the UK can carry out the technical conformity assessment of IVD devices for EU regulatory compliance, allowing manufacturers to affix the CE and UK(NI) marks for placing their devices on the market across the UK.
Sponsors of performance studies for new IVD devices in Northern Ireland will need to apply to an ethics committee in the UK for an ethics review, and hold sufficient insurance to meet any potential financial liability in the event of injury or death as a result of participation in the study. The instrument also creates an arbitration procedure for refused performance study applications. It allows performance studies of IVD devices and clinical investigations of medical devices taking place in both Northern Ireland and Great Britain to require only a contact person to be established in Northern Ireland, rather than a legal representative, supported by a sponsor or legal representative established in Great Britain. That reduces the burden on business and makes it straightforward for investigations to include sites across the whole of the UK. This will enable more studies and investigations to go ahead in Northern Ireland.
The instrument includes specific provisions to ensure unfettered access of qualifying NI IVD devices to be placed on the GB market with no additional barriers or burden. This product-specific legislation sits alongside general protections for Northern Ireland’s unfettered access to the rest of the UK market under the United Kingdom Internal Market Act 2020.
IVD devices play a critical role in maintaining patient and public health, and this statutory instrument will strengthen the regulation of these devices in Northern Ireland. It protects patient safety and facilitates consistency in IVD regulation between Northern and Great Britain, which will enable the whole of the UK to remain an attractive market for research and development of medical technologies, bolstering the UK Government’s commitment to the life sciences sector.
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.
Andrew Stephenson
I thank the shadow Minister for her remarks and her support in principle for the instrument. She asked about the MHRA’s capacity to deal with these new regulations. We have received assurances that the agency sees this as a tidying-up exercise. It welcomes the regulations, which it wanted to be introduced, and sees no capacity constraints.
To update GB regulations on medical devices with a specific focus on patient safety, the Government will bring forward secondary legislation in the near future. I cannot be more granular about the timescale, but we do intend to introduce that at the earliest opportunity.
We consulted widely on the draft regulations. I was in Northern Ireland on 4 January, when I spent the day meeting life sciences companies in Belfast and Lisburn. The Government are committed to promoting access to safe and effective IVD devices for all patients across the whole of the United Kingdom, and this SI supports that commitment by strengthening the MHRA’s enforcement powers in Northern Ireland. The MHRA has worked collaboratively with the Northern Ireland Department of Health throughout the development of the regulations, and will continue to do so to ensure their effective implementation and to monitor impacts on the market.
By supporting the regulations, we will ensure that the MHRA can effectively carry out its role as a regulatory authority in Northern Ireland, ensuring that patients in Northern Ireland and in Great Britain have access to safe and effective IVD devices. The provisions will reduce the burden on NI businesses when placing a device on the market. We believe the measure will generate innovation and attract investment into the UK and UK businesses, build on the life sciences strategy, and realise the opportunities in the life sciences sector. I am grateful to the Opposition for their support and to the Committee for considering the draft regulations today. I commend the regulations to the Committee.
Question put and agreed to.