Draft Medical Devices (Northern Ireland Protocol) Regulations 2021

Edward Argar Excerpts

Thursday 15th July 2021 General Committees

[The Chair]

Before we begin, I remind hon. Members to observe social distancing and sit only in places that are clearly marked—I think this is the last time we are saying this; it will not apply from Monday. I also remind Members that Mr Speaker has stated that masks should be worn in Committee. That does not apply to me because I might have to say something at any second. Our colleagues in Hansard would be most appreciative if you emailed your speeches to hansardnotes@ parliament.uk. I call the Minister to move the motion.

[The Minister for Health (Edward Argar)]

I beg to move,

That the Committee has considered the draft Medical Devices (Northern Ireland Protocol) Regulations 2021.

It is a pleasure to serve under your chairmanship, Dr Huq.

Today we are debating an instrument that is necessary to maintain the regulatory landscape for medical devices in Northern Ireland following a change in European Union law. It reflects the recent application of Regulation (EU) 2017/745 on medical devices in Northern Ireland, which applies to all general medical devices, but not to in vitro diagnostic medical devices. For simplicity, I will hereafter refer to the EU medical devices regulation. I draw the Committee’s attention to the fact that this instrument does not itself cause the EU medical devices regulation to apply within Northern Ireland. That legislation took automatic effect in Northern Ireland on 26 May this year under the terms of the Northern Ireland protocol.

Through this instrument, the Government deliver their commitment to the pragmatic implementation of the protocol by introducing provisions that minimise the impact of the EU medical devices regulation on economic operators and the public in Northern Ireland. The EU medical devices regulation contains some areas where states have the discretion to make their own policy choices. This instrument therefore legislates in those policy areas, and where possible seeks to align the position in Northern Ireland with that in Great Britain. The Medical Devices Regulations 2002—hereafter referred to as the 2002 regulations—will continue to be the relevant regulations for in vitro diagnostics devices in Northern Ireland. They will operate alongside the EU medical devices regulation itself and this instrument on the regulation of general medical devices.

The instrument achieves the Government’s commitment to align Northern Ireland with Great Britain where permitted in four areas. First, it implements national adjustments for Northern Ireland in areas where the EU medical devices regulation grants member states the ability to make national policy decisions. This has been done in a way that will align with policies in place in Great Britain. Secondly, it sets out the fee structures that keep fees charged by the Government aligned with those applied in Great Britain. Thirdly, the instrument sets out the enforcement regime for activity and violations under the EU medical devices regulation in Northern Ireland. Finally, it makes an amendment to existing regulations so that they take account of the application of the EU medical devices regulation in Northern Ireland.

Several aspects of this instrument are, as will become apparent, technical. I therefore might not be able to address all the elements in detail in the time that we have available. I will, however, provide the Committee with details on the most important provisions. I will first set out the provisions that the instrument makes to change default positions under the EU medical devices regulation where permitted.

Re-manufacturing single-use devices, which the EU refers to as reprocessing, is currently permitted in the UK as long as the re-manufacturer adheres to strict requirements. The EU medical devices regulation does not permit re-manufacturing, but grants member states the ability to make national allowances, which this instrument also does for Northern Ireland. That means that the re-manufacturing of single-use devices can continue to take place in Northern Ireland as it does in Great Britain as long as all requirements of the EU medical devices regulation are adhered to.

The instrument also introduces provisions so that the Medicines and Healthcare Products Regulatory Agency can continue to require the registration of custom-made devices. That means that a range of devices such as, for example, dental appliances or orthopaedic moulds must be registered before being placed on the Northern Ireland market, as is currently the case in Great Britain.

The instrument also ensures continued alignment between Great Britain and Northern Ireland so that the safety of participants continues to be protected in clinical investigations. It does so by maintaining the MHRA’s ability to authorise clinical investigations for all risk classes of medical devices before they can commence. It also upholds the requirement for custom-made-device clinical investigations to be subject to MHRA assessment.

As well as these provisions, which amend the default positions of the EU medical device regulation where permitted, this instrument also sets out the fees that the MHRA may charge for activity under the EU medical device regulation in Northern Ireland to continue covering the costs associated with certain aspects of the regulation of medical devices. All fees outlined in this instrument are identical to those charged for similar services in Great Britain under the 2002 regulations, thereby maintaining alignment.

The Government are maintaining identical fees as part of our commitment to ensure that, where possible, there are no disadvantages to economic operators in Northern Ireland as a result of the protocol. To that end, no new fees are introduced in this instrument for any new requirements under the EU medical device regulation.

The enforcement provisions introduced in this instrument provide the Secretary of State with enforcement powers to ensure that patient safety is prioritised and high standards are maintained for the people of Northern Ireland. It does so by creating a specific offence that relates to breaches of certain provisions of this instrument and of the EU medical devices regulation; by amending the Medicines and Medical Devices Act 2021 and the Consumer Rights Act 2015; and by granting the MHRA and district councils in Northern Ireland inspection powers and powers to serve enforcement notices for breaches of the EU medical device regulation within Northern Ireland. These powers allow the MHRA to respond to concerns and to constantly deliver improvements to patient safety.

Finally, the instrument includes technical amendments to other legislation, including the 2002 regulations, to reflect the application of the EU medical device regulation within Northern Ireland. In doing so, it ensures that the regulatory landscape operates effectively in Northern Ireland.

I should put on the record that I am grateful for the continued collaborative approach of officials in the Northern Ireland Executive, who have been kept informed of and engaged with the progress of this instrument. I also inform the House that, due to the very technical nature of this instrument, it has not met the threshold for an impact assessment and therefore one is not provided.

By introducing this instrument we are upholding the Government’s commitment to minimise the impact of the Northern Ireland protocol on the activities of the public and economic operators in Northern Ireland. The pandemic has shown that public health considerations are more important than ever, and by introducing this instrument we are taking steps to ensure that the UK’s exceptional standards of safety continue to be maintained within Northern Ireland.

I commend the instrument to the Committee.

--- Later in debate ---

[Edward Argar]

As ever, I am grateful to the shadow Minister—not only for adopting a typically sensible and pragmatic approach to these issues, but for his kind, if perhaps slightly inaccurate words, about my greying hair and my ageing.

The regulations are particularly about allowing the Government to meet their commitment to implement the Northern Ireland protocol, and doing so in a pragmatic way to minimise the impact on the activities of the public and, indeed, operators in Northern Ireland. We believe they do this while—quite rightly, as the hon. Gentleman said—maintaining the highest standards of patient safety for the people of Northern Ireland, as we would expect right across the United Kingdom.

One of the shadow Minister’s key themes was regulatory divergence and differences. As a Government, we are committed to adopting a pragmatic approach to regulatory divergence, seeking to minimise impacts wherever possible. He will have seen, from what I said just now, that the changes contained in this instrument are essential to delivering on that by providing, where possible, consistency and continuity between regulations in Northern Ireland and Great Britain, where of course we are not constrained by the EU medical devices regulation.

The shadow Minister raised a specific point about the scrutiny of CE and UK(NI) marks. As an experienced Member of Parliament, he will know that there will be many opportunities for the Opposition to table debates on these issues, either in the main Chamber or in Westminster Hall. If they wished to do so, Ministers—probably me—would be delighted to continue our touring double act on issues relating to the implementation of the trade and co-operation agreement and the Northern Ireland protocol.

The shadow Minister also talked about conversations and engagement with the Northern Ireland Executive, industry and others. That engagement continues on a wide range of topics relating to the Northern Ireland protocol and, more broadly, the implementation of the TCA, including continuity of supply and how industry is finding the implementation of the protocol. Not only have fora been hosted within the Department across the broad range of industry suppliers and the bodies representing them, at which we discuss these issues and seek out their views, but in the case of Northern Ireland and the Northern Ireland Executive, as I mentioned, we are very grateful for the collaborative working at an official level on these regulations and on other aspects of the implementation of the protocol. I have regular—at the moment, almost monthly—virtual meetings with my opposite number, Robin Swann, the Minister of Health in Northern Ireland. We discuss a range of topics, and as one would expect, the implementation of the protocol and measures such as these are among them so that we ensure as smooth an implementation and a result for the people of Northern Ireland as possible.

The shadow Minister mentioned the Northern Ireland protocol more broadly, and his views on the Government’s approach to it. It has always been the case throughout history that once international treaties and agreements are reached, tweaks are made to ensure they can be practically implemented on the ground. That is nothing new. It is true of treaties throughout history, and that is what we continue to work with our colleagues in Northern Ireland and the Commission to address.

Turning briefly to possible areas of regulatory divergence—I know this area has interested the shadow Minister in other debates on regulations—as I said, the instrument generally retains all the requirements of the directives it repealed, and indeed adds some additional ones to ensure consistency with GB. Those include additional rules for the designation of notified bodies, additional control and monitoring requirements for competent authorities, and additional clarifications of the roles of different economic operators. The EU medical devices regulation reclassifies some devices and has a wider scope than the directives. That includes devices for sterilising other medical devices and certain devices with no evident intended medical purpose, which is annex XVI of that regulation. A new unique device identification system is also introduced to enhance traceability and post-market activities related to safety. Additional requirements are also introduced for the publication of information on devices and clinical and performance studies relating to their conformity, and the new European database for medical devices and in vitro diagnostic medical devices—which I think the shadow Minister mentioned, and which I will come on to in a second. EUDAMED is also introduced to make data available in increased quantity and quality.

The UK will shortly consult on the future of the Great Britain medical devices regulations, which will benefit patient safety and access. That work on the future GB regulatory regime will explore any risks around regulatory divergence between GB and NI in that context. I hope that addresses the shadow Minister’s concerns, but I can reassure him that there will be opportunities for this issue to be debated and discussed—more broadly in the House, but probably in Committees such as this—when we get to that point.

I hope I have dealt with at least the majority of the shadow Minister’s points, but if there are any others he wishes to raise, he knows that he is always welcome to write to me. With that, I commend the regulations to the Committee.

Question put and agreed to.