Medical Devices (Northern Ireland Protocol) Regulations 2021

Baroness Thornton Excerpts

Monday 12th July 2021 Grand Committee

[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?