A “significant” number of essential medical devices made by small- and medium-sized medtech companies will go in short supply in Ireland in the event of a no-deal Brexit, according to a report in the Irish Times.
An Irish health service analysis of the possible effects of a hard Brexit revealed the number of devices that would go unregulated if the UK leaves the EU by October 31, 2020, without a deal, the newspaper reported.
The health service is “taking in additional stock in these vulnerable product lines,” including hospital equipment and implantable devices, one government official said. Ireland’s Health Products Regulatory Authority (HRPA) executive said larger manufacturers are better prepared to transition their UK device certificates to EU regulations, while smaller companies have had trouble obtaining certificates from EU notified bodies, the Times reported.
“As such, it remains the case that a significant number of UK certificates have not transitioned to an EU member state,” HRPA CEO Lorraine Nolan told a health service committee. “Historically there has been a high dependency on UK notified bodies for medical device certification activities.”