Medical Devices (Northern Ireland Protocol) Regulations 2021

Lord Dodds of Duncairn Excerpts

Monday 12th July 2021 Grand Committee

[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?