Concerns over supply of medical devices in event of no-deal Brexit

‘Significant’ number of UK suppliers will not have regulations in place by October 31st

Not all companies that produce medical devices in the UK have put measures in place to transition their UK  certificates to the necessary EU regulations.  Photograph: Bryan O’Brien/The Irish Times

Not all companies that produce medical devices in the UK have put measures in place to transition their UK certificates to the necessary EU regulations. Photograph: Bryan O’Brien/The Irish Times

 

Concerns have been raised about the supply of essential medical devices after it emerged that a “significant” number of products will not have adequate regulation if there is a crash-out Brexit.

The health service has conducted an in-depth exercise analysing medical devices, such as joint replacements and implants, for exposure to the UK. A “significant” number of suppliers will not have the necessary regulations by the end of October if the UK leaves the European Union without a deal, an Oireachtas committee heard.

The HSE’s chief strategy officer Dean Sullivan said the HSE was “taking in additional stock in these vulnerable product lines”. The HSE has said, however, that this does not amount to stockpiling.

Such medical devices could include hospital equipment and implantable devices in patients.

The chief executive of the Health Products Regulatory Authority (HPRA) Lorraine Nolan told the Oireachtas Committee on Health on Wednesday that larger manufacturers have measures in place to transition their UK medical device certificates to the necessary EU regulations.

Small and medium sized manufacturers have, however, indicated challenges in getting such certificates from EU bodies.

“As such it remains the case that a significant number of UK certificates have not transitioned to an EU member state,” she said.

“Historically there has been a high dependency on UK notified bodies for medical device certification activities.”

The HPRA has said it and other EU authorities were working together to develop and agree with the EU Commission, a European approach to manage UK certificates that have not transitioned by the deadline.

If such an approach was not agreed the HPRA said it had developed contingencies to manage this.

Each medical device on the market requires a CE mark to demonstrate conformity with the regulatory framework and for medium to high risk devices, a CE certificate issued by a Notified Body located in any EU member state.

In relation to medical devices, the HSE’s head of procurement John Swords said the availability of two million items across 274 companies was being examined by the health service.

Meanwhile, the secretary general of the Department of Health Jim Breslin said the health sector would need further Brexit funding beyond the €10m already committed, if the UK crashed out without a deal.

“This year we have committed over €10 million in funding to health sector Brexit preparations and, if Brexit proceeds on a no-deal basis on the 31st October next, it will be necessary to incur further costs this year and on an ongoing basis. We could do much to improve our health services with this money but instead we must use these resources to mitigate any potential Brexit impact on population health.”

He said he was confident that all existing north-south health cooperation will continue, including arrangements with Northern Ireland health service providers.

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