Mr David Wilson (Department of Health): Thank you, Chair, and good morning, members. I am the lead official for medical device safety. Thank you for the opportunity to provide the Committee with the Department of Health's current understanding of the European Commission's proposal for a regulation of the European Parliament and of the Council amending regulations (EU) 2017/745 — the medical devices regulation (MDR) — and (EU) 2017/746 — the in vitro diagnostic regulation (IVDR) — as regards simplifying and reducing the burden of the rules on medical devices and in vitro medical devices and amending regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and regulation (EU) 2024/1689 as regards the list of union harmonisation legislation referred to in its annex 1.
The Department of Health has an interest in the amendments to the EU MD and EU IVD regulations, which have applied in Northern Ireland since 26 May 2021 and 26 May 2022 respectively via annex 2, section 21 of the Windsor framework. I will refer to those regulations as "EU MDR" and "EU IVDR" for the remainder of the statement.
Medical device regulation is a reserved matter. Given that the aim of the regulations is patient safety, the DOH has taken a lead role in the assessment of the proposal. The proposal impacts on industry and the placement of medical devices on the GB, EU and NI market. The Department continues to engage with colleagues in the Department for the Economy, given the likely impact of the proposed amendments on industry in Northern Ireland.
The proposal for an amending regulation to the regulations was published on 16 December 2025. The objective of the regulation is to simplify and reduce the regulatory burden involved in bringing medical and in vitro medical devices to the market. I hope to provide the Committee with the relevant information from a Health perspective regarding any anticipated impacts of the proposal on Northern Ireland. The proposed regulation lays targeted amendments to improve the function of the current regulatory framework, primarily through the smooth functioning of the internal market, while ensuring high-level protection for patients.
By way of background, I note that the Commission conducted a targeted evaluation of the current EU MDR and EU IVDR covering the period between their adoption on 5 April 2017 and 31 December 2024. While an evaluation was legally required by May 2027, the targeted evaluation was initiated earlier in recognition of the perceived challenges in the transition of the regulations from the original medical device and in vitro device directives. That has led to provision being made for extended transition periods.
Whilst EU MDR and IVDR implementation is ongoing, the evaluation assessed how the regulations were performing up to December 2024, focusing on the impacts on device availability, innovation, costs and administrative burdens, especially for small and medium-sized enterprises. The Commission noted that the EU MDR and IVDR provided benefits for patients through stronger patient safety requirements and oversight mechanisms. However, it discovered that compliance costs were disproportionate and unevenly distributed, affecting small and medium-sized enterprises and niche device manufacturers in particular. The Commission concluded that there was a need for targeted adjustments to better align with evolving markets.
In response to the evaluation, the Commission took the view that streamlining procedures and reducing administrative complexity, along with more flexible regulatory pathways, would help balance the regulatory burdens against the public health gains. Those goals are a key aim of the proposed regulation, which seeks to deliver a more efficient and cost-effective regulatory framework that will benefit manufacturers, notified bodies and healthcare systems.
As medical device regulation is a reserved matter, the Department continues to work closely with colleagues in the Department of Health and Social Care (DHSC) and the Medicines and Healthcare products Regulatory Agency (MHRA). We have worked together to inform this statement on the assessment of impact and to address the Committee's specific questions.
Question 1 relates to the impact of divergence between GB and NI and possible consequences for the supply of medical devices and IVDs from GB to NI. We understand that, because we follow the EU MDR and IVDR and the UK Medical Devices Regulations 2002, under the proposed changes, the two sets of regulations will remain broadly aligned. The Department does not anticipate any additional consequences for the current position. Given that the proposals are aimed at reducing the regulatory burden for the sector, it may be easier for GB companies that supply NI to obtain CE accreditation and thus supply NI and the EU.
Question 2 seeks the number of medical and in vitro diagnostic device manufacturing companies in NI. The Department of Health does not hold that information. However, the MHRA has clarified that 72 Northern Ireland companies are registered on its online database.
Question 3 asks for clarity on DOH and MHRA engagement with stakeholders on the proposed EU act. At this stage of the EU legislative process, we continue to work with the DHSC and the MHRA to fully understand the objectives and potential impacts of the proposals. When appropriate, the MHRA will lead stakeholder engagement as required.
Question 4 concerns the removal or reduction of requirements in the current regulatory framework. At this early stage, DOH does not have any concerns, given that any reduction in administrative burden on the medical device sector that does not reduce patient safety should be beneficial in increasing the availability of devices for patient care.
Question 5 refers to the current MHRA consultation on potential divergence and future plans for regulatory change. The policy is reserved, and proposed UK regulations have not been published, so we cannot comment. However, our understanding from engagement with the MHRA and the DHSC is that the regulations will align more closely in some respects. DOH does not anticipate any additional consequences for the current position or potential impacts on supplies for NI.
Question 6 is on the Department's engagement with the UK Government on the proposed EU act. I can confirm that we engage frequently with the MHRA and DHSC in the policy area, including directly on the proposed EU act.
Questions 7 and 8 query why a separate regulatory framework for NI may be required and whether "trivergence" will have implications for NI supplies. It is our understanding that, if the proposal were not to apply to NI, the existing EU MDR and IVDR regulatory frameworks would continue to apply. In that scenario, all manufacturers would have to follow regulations to supply the NI market that were different from those needed to supply the wider EU and GB markets. That would be likely to involve an additional cost and, potentially, given the size of the Northern Ireland market, lead to supply disruptions.
Question 9 relates to non-application of the proposed EU act and how that may affect and potentially disadvantage relevant businesses in NI. Device manufacturers will follow the relevant regulatory regime for the market in which they wish to place their products. If NI manufacturers wish to sell to the EU, they will follow the new regulations, if adopted. That will allow them access to the GB market via unfettered access for NI CE-marked goods. Non-adoption may mean that manufacturers have to follow the current regulations to supply the Northern Ireland market, bearing the associated regulatory burden and potential negative impacts, including additional costs and/or market withdrawal.
The European Commission's proposed amendments relate to the streamlining of compliance procedures and administrative burdens for industry and health institutions. The Department's understanding is that the overall impact on the DOH will be negligible. Furthermore, direct and indirect benefits to the health sector may be realised through increased device availability and lower costs.
I trust that members found that information useful. As it is an emerging legislative proposal, DOH will endeavour to keep the Committee updated should any significant changes become apparent.
Thank you for the opportunity to brief you today.
Mr Brooks: This is more of a comment than a question, but, if you want to add anything, you are more than welcome to do so. I was going to ask how the changes in classification will interact with the classification in GB and about any divergence in that sense, but you largely dealt with that in your written answer to question 5.
Unfortunately, as with much of the stuff that the Committee interacts on with Departments, there are things that you cannot comment on and things that may happen on the basis of informal engagement. We asked for your insight, so thank you for giving that. Nevertheless, when the time comes, I will probably propose that we monitor the progress of the proposal on the basis that you have done your best to give us all the information that you can but I am not sure that it is everything that we need.