Medical Devices (Northern Ireland Protocol) Regulations 2021
(3 years, 5 months ago)
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Lord Bethell
That the Grand Committee do consider the Medical Devices (Northern Ireland Protocol) Regulations 2021.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
My Lords, the statutory instrument that we are discussing today relates to the regulations for medical devices within Northern Ireland. It reflects the application of EU regulation 2017/745 on medical devices, which I will hereafter refer to as the EU medical devices regulation, under the terms of the Northern Ireland protocol. As noble Lords will be aware, the protocol agrees to continue applying certain EU rules in Northern Ireland to recognise the unique status of Northern Ireland within the UK and to uphold the Belfast/Good Friday agreement. It is important to remember that this instrument does not apply the EU medical devices regulation within Northern Ireland. That legislation took automatic effect in Northern Ireland from 26 May this year, under the terms of the Northern Ireland protocol.
The EU medical devices regulation contains some flexibility areas, where states have the discretion to make policy decisions and adjustments. This instrument therefore makes provisions to apply in Northern Ireland where it serves to align Northern Ireland policy with Great Britain. This is to deliver the Government’s commitment to the pragmatic implementation of the Northern Ireland protocol. In creating the provisions in this instrument, we are minimising the impact on economic operators and the public in Northern Ireland, as the Northern Ireland protocol pledges.
The Medical Devices Regulations 2002, hereafter referred to as the 2002 regulations, will continue to be the relevant regulations for in vitro diagnostics in Northern Ireland, and will operate alongside the EU medical devices regulation and this instrument on the regulation of medical devices and active implantable medical devices.
I shall give some background. This 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 aligned with those applied in Great Britain. Thirdly, it sets out the enforcement regime for activity and violations under the EU medical devices regulation in Northern Ireland. Lastly, it makes amendments to existing regulations, to take account of the application of the EU medical devices regulation in Northern Ireland.
I will first describe areas of national flexibility where this instrument makes provision to change default positions under the EU medical devices regulation to maintain Northern Ireland policy with that of Great Britain. The Government currently permit the remanufacturing of single-use devices, which the EU refers to as reprocessing, so long as the remanufacturer adheres to strict requirements. The default position of the EU medical devices regulation is not to permit remanufacturing unless there is national legislation in place to support it. This instrument does just that. This means that the remanufacturing of single-use devices can continue to take place in Northern Ireland, as well as in Great Britain, so long as requirements under the relevant legislation are followed.
The instrument also introduces provisions so that the MHRA can continue requiring custom-made devices, ranging from dental appliances to orthopaedic moulds, to be registered before being placed on the Northern Ireland market. Provisions are also contained in this instrument that uphold our national requirements for clinical investigations, which are crucial for ensuring that the safety of participants is protected. They do so by maintaining the MHRA’s ability to authorise clinical investigations for all risk classes of medical devices before they can commence. Furthermore, it upholds the requirement for all clinical investigations for custom-made devices to be subject to MHRA assessment. The Government remain committed to delivering improvements to patient safety, and this instrument means that we can respond proactively to any concerns.
By amending the Consumer Rights Act 2015 and the Medicines and Medical Devices Act 2021, this instrument provides the MHRA and district councils in Northern Ireland with inspection powers and powers to serve enforcement notices for breaches of the EU medical devices regulation within Northern Ireland. This will ensure that the MHRA has the enforcement powers it needs to ensure patient safety is prioritised and high standards are maintained for the people of Northern Ireland.
The MHRA charges fees to cover the costs associated with certain aspects of the regulation of medical devices. This instrument details fees which may be charged for activity under the EU medical devices regulation in Northern Ireland, keeping them identical to those charged in Great Britain under the 2002 regulations for similar services. This upholds the Government’s commitment to ensure that there are no disadvantages to economic operators in Northern Ireland as a result of the Northern Ireland protocol. This instrument does not introduce any fees for new requirements under the EU medical devices regulation.
Finally, this instrument makes technical amendments to other legislation, including the 2002 regulations, to reflect the application of the EU medical devices regulation within Northern Ireland. This will ensure the regulatory landscape operates effectively in Northern Ireland. Officials in the Northern Ireland Executive have been kept informed of the progress of this instrument and I am hugely grateful for their continued collaborative approach. As the nature of the changes in this instrument are technical in many instances, the impacts of the instrument do not meet the threshold for impact assessments, hence these are not provided.
In conclusion, this instrument upholds the Prime Minister’s commitment to the Northern Ireland protocol and to minimise the impact on the activities of economic operators and the public in Northern Ireland. The significance of our public healthcare system has never been clearer than during the Covid-19 outbreak, and this instrument will ensure that the UK’s exceptional standards of safety are maintained within Northern Ireland. This is something we must support. I commend the regulations to the Committee.
The Deputy Chairman of Committees (Baroness Healy of Primrose Hill) (Lab)
The noble Lord, Lord Hunt of Kings Heath, has withdrawn, so I call the next speaker, the noble Lord, Lord McColl of Dulwich.
Lord McColl of Dulwich (Con) [V]
My Lords, as there are more than half a million of these devices on the market, it is understandable that effective regulation should be in place and workable. It is also clear that most of us will need one of these devices at some time in our life. It is to be hoped that these regulations will give patients more information and choice, and that they will benefit from more up-to-date therapies. I ask the Minister this: what will be the effective way of seeking expert opinions on the wisdom of a proposed new operation that does not necessarily involve a medical device? It would be helpful to have a second opinion on whether it is likely to be feasible and safe.
As there are often notoriously long delays in obtaining answers from official bodies, and we are talking about regulations now, has any thought been given to placing a regulation to require answers within a certain time?
There has been discussion about a robust financial compensation mechanism to ensure that patients are dealt with fairly and justly for the damage caused by defective devices and by their inappropriate use in certain parts of the body. For instance, the mesh which caused so much damage in operations for incontinence is used widely and safely in hernia operations. Could the Minister tell the Committee who will operate these compensation mechanisms? Who will decide whether compensation is justified and how much to award?
Lord Empey (UUP) [V]
My Lords, in his introduction, my noble friend the Minister talked about upholding the protocol and upholding the Belfast agreement. I say to my noble friend that the protocol, and what is flowing from it, including what we have before us today, drives a stake through the heart of the agreement because it breaches one of the fundamental principles—but that is an argument for another day.
The Minister also referred to enforcement regulations. What we are trying to do here is to circumvent the imposition of rules and regulations on these devices that will be made by the European Union and ratified by the European Parliament as we move forward. We will have no say or role in any of that—neither will the Minister—so we are trying to pretend that we are not simply rule-takers here. We are trying to indicate that we are doing something that will have an impact and minimise the damage. That is basically what this is about.
I would like to know from the Minister what the future will hold. The United Kingdom and the European Union basically start off on the same page, because we spent 43 years as part of that union and were involved in all the standards that were set up until this point, but those will diverge over time. I want to know from the Minister what his and the Government’s approach will be if, over time, these regulations start to diverge.
We saw on the vaccine issue that the European regulatory regime operated at a much slower pace than our own, here in the United Kingdom. What would be the implications in future if devices were conceived and made available in Great Britain, under whatever rules might apply, but had not been accepted in the European Union? Would people living in Northern Ireland not get access to such devices in future? That is at the core of our concerns over this and a whole range of other items that will arise from the protocol.
Lord Lansley (Con)
My Lords, I am grateful to my noble friend the Minister for his clear introduction to these regulations. I want to take the opportunity to comment on just one aspect of these arrangements: the processes for a conformity assessment on medical devices placed on the market in Northern Ireland.
A European conformity assessment, a CE mark, is to continue to be recognised in the Great Britain market until 30 June 2023. Likewise, the certificates issued by EU notified bodies will continue to be recognised until that date. It seems to me that, if one is a Northern Ireland-based manufacturer of a medical device—the Explanatory Memorandum estimates that there are some 300 such businesses—for the next two years the CE mark should be a sufficient basis for placing a product on the market, whether in the EU, Northern Ireland or Great Britain. I would be grateful if my noble friend were in a position to confirm what I say or correct me.
If a Great Britain manufacturer is meeting EU requirements then, from 2023, it will require a UK conformity assessment, but this in itself will not enable its product to be placed on the market in Northern Ireland—hence the references in these regulations to the “UK(NI) indication”, which appears to become of greater significance after 1 July 2023. From that time onwards, British manufacturers will be required to adopt dual marking and conformity assessment through two systems, with the attendant cost and complexity. Obviously, the same is true for non-EU third-country suppliers.
At the heart of this problem is the failure of the trade and co-operation agreement to provide for mutual recognition of conformity assessments, given the simple fact that, as my noble friend Lord Empey adverted to, our MHRA undertook 40% of the most significant assessments in the EU. We do not have divergent technical standards; what we have, unfortunately, are divergent political priorities. I personally do not blame Theresa May’s negotiators for our failure to secure that mutual recognition.
One option now would be to roll forward our recognition of European conformity assessments—the CE marking—beyond 2023. Frankly, I do not expect that to happen, because it would undermine the role of the MHRA and British notified bodies, but can my noble friend explain what the position will be for Northern Ireland manufacturers post 1 July 2023? Given the principle of unfettered access to the UK market, will they be able to sell in Britain on the basis of their CE mark or will they require dual marking? This regulation makes provision for the UK(NI) indication, which is useful for UK manufacturers using a previous EU approval and for British devices to access the Northern Ireland market, but it seems to me no more than a face-saving approach to cover the harsh reality that we are going to put our highly successful medical devices sector through significant additional cost, disruption and bureaucracy.
Lord Dodds of Duncairn (DUP) [V]
My Lords, I begin by thanking the Minister for his clear explanation of the purposes of this secondary legislation. The statutory instrument is necessary, of course, only because of the Northern Ireland protocol, as the Minister made clear. That protocol means that EU law is applied to Northern Ireland across a wide range of matters without any elected Member of the Stormont Assembly or this Parliament having any vote on the matter.
On Friday, in evidence to the Northern Ireland Assembly, the noble Lord, Lord Frost, said that
“you need to have broad consensus”
to make the protocol work between now and four years’ time,
“and the fact we don’t have it is what worries us so much.”
He has also said previously, in speaking to the Northern Ireland Affairs Select Committee on 16 June, that
“the protocol depends on consent. It is very difficult to operate it if there is not consent and willingness from one segment of Northern Ireland opinion”.
I am sure the Minister will confirm his agreement with his ministerial colleague on this vital issue.
So we have before us this afternoon a situation where the EU regulation on medical devices entered into force in Northern Ireland directly on 26 May, and Northern Ireland is now subject to the EU regulatory system for medical devices and not the UK one. This statutory instrument is necessary to try to meet the challenges and practical applications of the EU directive applying directly to Northern Ireland. Whatever the mitigations, it would be better in every sense if Northern Ireland were simply in the same regime as the rest of the United Kingdom. Most medical devices, and £600 million-worth of medicines, are brought into Northern Ireland every year, 98% of which are from Great Britain. As has been mentioned, there are 300 operators of medical devices in Northern Ireland affected by this SI.
Following up on what the noble Lord, Lord Lansley, referred to, can the Minister confirm that the CE marking will be required indefinitely for devices placed on the Northern Ireland market by manufacturers, unlike in the rest of the United Kingdom? Can he confirm that the somewhat bizarre UK(NI) marking will be needed if a UK-notified body undertakes third-party conformity assessment? Can he also confirm that, to place a device on the Northern Ireland market, Great Britain manufacturers will need to appoint an EU or Northern Ireland-based authorised representative? The complexity and extra bureaucracy of all of this, and the cost to the taxpayer, need to be called out and quantified.
The applicability of the EU regime in this area adds not one jot to the safety or security of the people of Northern Ireland. Having Northern Ireland under the UK regime for medical devices would not harm or endanger the EU single market in any way. The whole basis of this SI is unnecessary and undemocratic.
Finally, the noble Lord, Lord Frost, has indicated that the EU is yet to respond to 12 papers tabled by the UK Government. Can the Minister indicate in his response whether any of them relate to medicines or medical devices?
Lord Bhatia (Non-Afl) [V]
My Lords, the changes that the EU MDR introduces will affect medical device economic operators in Northern Ireland, estimated to be about 300, and any prospective UK notified bodies. This instrument does not implement the EU MDR itself, but updates the statute book to allow us to implement the EU MDR effectively and addresses areas of national decision to align with policy that applies in the rest of the UK. Specifically, these areas of national decision allow for the continued practice of allowing the reprocessing of single-use devices, if reprocessors adhere to the requirements of an original manufacturer. The instrument will also give the MHRA powers to serve enforcement notices for breaches of the EU MDR.
The instrument will correct current legislation where required, introduce relevant enforcement provisions and outline the fees structure for Northern Ireland. It will introduce provisions in areas of flexibility allowed for under the EU MDR, to allow Northern Ireland to continue to align with Great Britain policy, where possible.
In addition to the 2002 regulations, the instrument also makes amendments to the following retained EU law: namely the Blood Safety and Quality Regulations 2005, to include a reference to the EU MDR alongside the reference to the 2002 regulations; and the human tissue regulations 2007, to include a reference to the EU MDR in order to maintain the scope of the regulations.
I believe that this instrument will protect the safety of medical devices that will be used in the UK and Northern Ireland.
Baroness Hoey (Non-Afl) [V]
My Lords, I thank the Minister for his explanation. In moving this SI, he made a very brave attempt almost to make it seem as if it is terribly normal and wonderful and no one should be worried about anything in it. In fact, he has made the best of a bad job because, as the noble Lords, Lord Empey and Lord Dodds, said, the reality is that this SI is not something we should even be thinking of discussing, let alone supporting.
I accept that some of the moves in it are to make things a little better for the 300 or so device manufacturers in Northern Ireland, and to make it seem—as the noble Lord, Lord Empey, said, it is almost a pretence—as though there is nothing wrong with what is happening. It is particularly sad to say today—and I hope that everyone has had a good Twelfth of July, at the commemoration and celebrations going on in Northern Ireland—that we are in a situation where the protocol is now dividing Northern Ireland from the rest of the United Kingdom, more and more. What we have seen today will be the first of many inevitable divergences, not just in this area of medical apparatus and medical issues but throughout, because we are left in the situation where the European Union is going to make those laws.
As has been said by many of us, over and again, and as has been said today by the noble Lords, Lord Dodds and Lord Empey, this is completely undemocratic. No one has been asked about this. From 21 May, we have simply had to take what the European Union has said on this issue. Whether it is right, wrong, good or bad is not the issue; the issue is one of basic democracy and consent. It is even in the Explanatory Memorandum, which talks about allowing
“Northern Ireland to continue to align with Great Britain policy where possible.”
Who decides “where possible”? It certainly will not be the people of Northern Ireland; it will be when and where it is permitted under the EU.
We are now a little colony of the European Union for certain regulations within the single market. The reality of this has to be accepted by the Government. This will be one of many SIs; I am not prepared to simply nod them through in future. The Government will have to face up to the fact that, if they try to nod them through, many of us will vote against them. We will not win, but the reality is that we have to show the Government that what they are doing is undemocratic and not in the interests of the United Kingdom.
Baroness Ritchie of Downpatrick (Non-Afl) [V]
My Lords, I thank the Minister for his explanation of these regulations. I accept what the statutory instrument is intended to do. However, I have some questions, as I want to see streamlined processes with no impediments to the supply of medical devices into Northern Ireland or to those that are currently under construction. There are about 500,000 medical devices, ranging from sticking plasters to dental implants to hip replacements, so they have many forms and functions. We are trying to achieve pragmatic solutions under the protocol to ensure that there are no impediments to their supply.
I have several questions for the Minister. Does the existing legislation on medicines and medical devices, which was approved in Parliament last year, have corresponding legislation in Northern Ireland to ensure that people with particular mesh problems will have a resolution and see an improvement to their health?
Furthermore, on the protocol, what discussions are taking place in the joint committee and the specialised committee with the EU on the exportation issues relating to the transfer of medical devices and medicines, to ensure that they will all continue to be supplied post December 2021? For example, the Royal College of Podiatry and the Ethical Medicines Industry Group are seeking mutual recognition agreements for the supply of those medicines and medical devices post 2021 as part of the protocol. What progress has been made in this regard? What evidence is there of working together to arrive at a long-term solution that avoids unnecessary regulatory complexity and duplication?
Given that the risk of medicines leaking into the EU single market from Northern Ireland in an unregulated manner is very slim, an agreement that permits medicines licensed for use in GB to be supplied to Northern Ireland only without additional checks would deliver on both sides’ needs. What steps are being made in this regard by UK and EU negotiators?
Do the common frameworks on blood safety and quality, on organs, tissues and cells, and on public health intersect with the protocol? What pressure can be brought to bear on the Northern Ireland Executive to sign off on these common frameworks, which deal with technical and policy divergence between Whitehall and the devolved Administrations? I look forward to the Minister’s responses to these issues on this important matter for the people of Northern Ireland.
Baroness Brinton (LD) [V]
My Lords, I thank the Minister for a non-urgent statutory instrument that was tabled on 16 June and is being debated at an appropriate time, after MPs and Peers have had the opportunity to look at it in detail. I am sure I am not alone in looking forward to more of these in future. I also thank him for his helpful explanation at the start of this debate.
These regulations set out the mechanism to adjust legislation to ensure that the use of medical devices complies with both the EU’s and Great Britain’s regulations. As the noble Lord, Lord McColl, said, most people in Northern Ireland are likely to need to use one of these devices during their lives, so it is important that we get it right. He also referred to the problems with certain devices covered in the Cumberlege review. Can I further refine his question to the Minister? Which Minister will be responsible for the delivery of the Cumberlege review in Northern Ireland? Will it be the Minister in Stormont or the Minister in Westminster?
Even though it has been made necessary by the Northern Ireland protocol, this SI appears to have been come to sensibly, solving the problem without the noble Lord, Lord Frost, or the Prime Minister immediately blaming the EU. That has to be encouraging because an enormous amount of detail has to be sorted out. The noble Lords, Lord Empey and Lord Dodds, and the noble Baronesses, Lady Hoey and Lady Ritchie, set out their frustrations with these regulations as an inevitable necessity resulting from the Northern Ireland protocol. From these Benches—over the past three years, at least—we have warned about the problems of what became the Northern Ireland protocol and the position that it would leave Northern Ireland in, which we deplore. However, given that this Government pushed through the Northern Ireland protocol with the withdrawal Act, we believe that the issues with the implementation of the protocol will be solved only by the EU and the UK working together to find a solution.
It appears that this SI might be one of the first to take that route. This is at least better than the noble Lord, Lord Frost, and the Secretary of State for Northern Ireland, Brandon Lewis, going to the Irish press just after 21 June to accuse the EU of adopting a theological approach to the protocol that is frozen in time, only a few days after the European Commission had announced its proposals for, among other things, medicines entering NI to be exceptionally regulated by the UK. That is a step forward, despite the concerns raised by the Northern Ireland Peers.
This SI lays the pathway for current legislation to be amended, including the creation of a criminal offence. Can the Minister say what scrutiny there will be by Parliament of this specific offence nearer the time? The Explanatory Memorandum makes it plain that this is not
“to address a deficiency in retained EU law”
but because of the withdrawal Act, as has been mentioned. It is good to have that confirmed, although some detail is about the UK elements of its parallel regulation. We are just going to have to become used to this, but I have some questions about the fees for applications and inspections.
Paragraph 12.4 of the Explanatory Memorandum says that “fees for services” will be
“kept on par with those charged in Great Britain, despite there being additional resource requirements to carry out the work under the EU MDR. The fees … will therefore be below the cost recovery level.”
Which Government will bear the cost of that extra work if it cannot be recovered from the manufacturers? Will it be the UK Government or the Northern Ireland Assembly? I hope the answer is the UK Government because the Northern Ireland Assembly should not have its budget penalised because of the Prime Minister’s decision to support the Northern Ireland protocol. In Regulation 12(1)(a) of the SI, in relation to “Prior authorisation of clinical investigations by the Secretary of State”, will the Secretary of State have these powers elsewhere in the UK or does this relate only to Northern Ireland?
Baroness Thornton (Lab)
I thank the Minister for introducing these regulations and for the opportunity to debate them. This debate takes place in the context of the Northern Ireland protocol, a protocol signed by this Government and now readily disowned by the very people who agreed to it. When the noble Lord, Lord Frost, says that it is not right to view the protocol as a definitive text, that does not reflect well on our country, its Government and the people who signed it at the time, said that it was excellent and denied that it would create a border in the Irish Sea. It is a bit rich of the noble Baroness, Lady Hoey, to protest, given her role in getting us to where we are.
However, I agree with the noble Baroness, Lady Brinton, that this is an attempt to find a way through on the important matter of medical devices. The SI addresses the fact that, although under the Northern Ireland protocol medical devices regulations are fully applied in Northern Ireland, the MHRA remains the Province’s regulator; there therefore needs to be provisions for enforcement, fees et cetera so that those elements of MDR that allow for national decision—such as on the reprocessing of single-use devices, custom-made devices and so on—are consistent across the UK.
What does this mean for people in Northern Ireland? What impact will there be if the EMA and MHRA depart markedly from each other’s regulatory regimes, and what would that mean for businesses? At the moment, you need a CE mark to go to market, as least as long as the Northern Ireland protocol holds. That is potentially advantageous for NI patients versus GB ones, as the vast majority of products will be CE marked and will continue to be so. However, as the ABPI has said, there are 600,000 medical devices approved in the EU and, at the moment, they are all available in Great Britain. Surely the test of the new UK regulations will be how many of them are still available in three, five or 10 years’ time. I hope that the Minister will be able to address those issues.
I seems to me that the final decision concerning the availability of a product would ultimately be a matter for the EU. Is it the case that, for those products authorised under the decentralised procedure by one member state acting as a reference for another member state, the MHRA would be able to suspend the use of a product only if one of the 27 member states had triggered a review of that product?
I have a couple of other points. I could see no mention of in vitro diagnostic medical devices. Will they come as another statutory instrument? I would be grateful if the Minister could clarify that. Can he tell the Committee what plans he has to update the House on a regular basis on the supply and regulation of medicines and medical devices in Northern Ireland to ensure that regulatory alignment and mitigation against adverse consequences are undertaken?
Finally, on enforcement, the instrument will also give the MHRA powers to serve enforcement notices for breaches of the EU MDR. How many people are these enforcement measures expected to affect? Manufacturers will need to take a number of steps to ensure that their goods can still be sold after the 2023 deadline, as noble Lords mentioned. What discussions have the Government had with the sector? Can the Minister confirm that the threshold to obtain the UKCA certification mark will largely be the same as that for the CE mark?
Lord Bethell (Con)
My Lords, as a responsible Government, it is absolutely imperative that we deliver on the Northern Ireland protocol and do so pragmatically to minimise the impact on the activities of economic operators and the public in Northern Ireland. As was intimated by the noble Baronesses, Lady Thornton and Lady Brinton, we are trying to find a way through. I believe that this instrument achieves that and, in doing so, ensures that high standards for patient safety are maintained throughout the United Kingdom.
I assure the noble Baroness, Lady Hoey, and other noble Lords who asked similar questions that the Government are fully committed to a system of medical device regulation that prioritises safety and safeguards public health. As such, the department has sought to minimise any disruption to patients and industry by providing consistency in policies where that is possible and ensuring a functioning statute book for the regulation of medical devices in Northern Ireland.
My noble friend Lord McColl asked about an advisory body. No formal advisory body is currently planned, but we will take his suggestion on board. NHS Digital is working with industry on a surgical devices register and, as such, is extremely engaged with industry in the manner to which he alludes. On the matter of deadlines, I agree with him about the importance of high service levels, but that is best left for management, not for secondary legislation. Compensation is covered in a large number of fora, including the courts, and is best left there.
I reassure my noble friend Lord Lansley about the Government’s commitment to unfettered access. As set out in the Government’s Command Paper of 20 May 2020, the UK’s approach to the Northern Ireland protocol ensures unfettered access to Great Britain for Northern Ireland businesses. It protects the territorial integrity of the UK by safeguarding Northern Ireland’s place in the UK’s customs territory and keeps goods flowing between Great Britain and Northern Ireland, applying measures that help to maintain food supplies and, of course, the flow of medicines. This includes access for medical devices from Northern Ireland businesses that are CE or CE-and-UKNI marked. The CE or CE-and-UKNI marking applies to Northern Ireland now and after June 2023.
My noble friend Lord McColl asked about mesh. We wholeheartedly commit to demonstrating to the patients and families who have shared their experiences during the Cumberlege review, and to anyone else who has suffered, that we have learned from them and are changing and improving because of what they have told us. The SI focuses on implementing the EU medical devices regulation in Northern Ireland under the specific powers of the European Union (Withdrawal) Act 2018, which would not extend to making changes to the regulations to respond to my noble friend Lady Cumberlege’s review. The Medicines and Medical Devices Act 2021 provides the powers for future regulations that have patient safety at their heart, and we are reflecting on the lessons from the Cumberlege review for future regulations. We will consider questions on the responses.
The points made by the noble Lord, Lord Dodds, on the 300 manufacturers are extremely well made. I reassure him that we are committed to implementing the protocol, but we must do so in a way that is sensible, balanced and attuned to the unique circumstances of Northern Ireland. As the noble Lord has already noted, my noble friend Lord Frost and the Secretary of State for Northern Ireland have recently made public statements on the Northern Ireland protocol. The Government are carefully considering next steps and will set out their approach to Parliament before the Summer Recess.
I reassure the noble Lords, Lord Dodds and Lord Empey, and the noble Baronesses, Lady Hoey and Lady Ritchie, that the Government are committed to adopting a pragmatic approach to regulatory divergence, seeking to minimise the impacts wherever it is possible to do so. I cannot emphasise enough that the changes contained in this instrument are essential to delivering on that commitment. The instrument does so by providing consistency between regulations in Northern Ireland and Great Britain where we are not constrained by the EU medical devices regulation. The instrument also ensures that when a medical device complies with the EU medical devices regulation and is a qualifying Northern Ireland good, it can be placed on the market in Great Britain without needing to meet any further regulatory requirements.
The noble Lord, Lord Empey, asked about future regulation. I reassure him that for a two and a half year period after the end of the transition period, devices compliant with EU medical devices regulation and EU in vitro diagnostics regulation can be placed on the Great Britain market as part of the UK’s acceptance of EU-regulated CE goods.
In answer to the noble Baroness, Lady Thornton, the UK will be consulting shortly on the future of Great Britain’s medical device regulations which will include a review of the elements of EU medical devices regulation and EU in vitro diagnostic devices regulation which benefit patient safety and patient access. Work on the future Great Britain regulatory regime will explore any risks around regulatory divergence between Great Britain and Northern Ireland.
To the noble Baroness, Lady Brinton, as I said in my opening remarks, by keeping the fees in Northern Ireland the same as those charged for equivalent activities in Great Britain under the 2002 regulations, this instrument ensures that there are no financial deterrents which may cause any disadvantage for Northern Ireland manufacturers or those carrying out clinical investigations.
By way of summing up, I thank noble Lords for their valuable contributions to this debate. I reassure all noble Lords that as a Government we are fully committed to ensuring that patient safety in all parts of the UK is prioritised and that high standards are maintained within Northern Ireland. I am enormously grateful for the support shown by many noble Lords for these measures, and I commend these draft regulations to the Committee.
The Deputy Chairman of Committees (Baroness Healy of Primrose Hill) (Lab)
The Grand Committee stands adjourned until 3.35 pm. I remind Members to sanitise their desks and chairs before leaving the Room.