Out-Law News | 26 Sep 2019 | 2:36 pm | 3 min. read
The HPRA is currently assisting the Health Service Executive with its review of the impact of Brexit on the supply of medical devices in Ireland. Lorraine Nolan, chief executive of the HPRA, told a parliamentary committee in Ireland that many medical device manufacturers currently rely on UK-based notified bodies to issue a CE marking for their devices which enables them to sell those devices on the EU market.
In the event of Brexit, however, UK notified bodies will no longer be able to perform this role. This is because EU law requires that CE marks are issued by a notified body located in an EU member state.
Nolan admitted that not all manufacturers of medical devices in Ireland are ready for this change.
"From our engagement, we know that larger manufacturers have measures in place to transition their UK medical device certificates to an EU27 notified body, while many small and medium sized manufacturers have indicated that their main challenge is in securing an EU27 notified body to issue new certificates," Nolan said. "As such it remains the case that a significant number of UK certificates have not transitioned to an EU member state."
Nolan said notified bodies across the EU have limited capacity currently to "take on additional certification activities" as they prepare for new EU medical device regulations to take effect in May 2020 and that this is a factor hindering Irish SMEs in the medical device market.
Work is being undertaken to develop "a European approach" to help manufacturers, she said.
"The HPRA and other EU authorities are working together to develop and agree with the EU Commission, a European approach to manage UK certificates that have not transitioned by the deadline," Nolan said.
"If such an approach is not agreed the HPRA has developed contingencies to manage this. Given that a medical device which becomes non-compliant with regulatory requirements after the 31 October does not present an immediate risk, we will work to ensure continuity of care for patients whilst ensuring that products return to compliance as quickly as possible," she said.
Dublin-based life sciences expert Aoibheann Duffy of Pinsent Masons, the law firm behind Out-Law, said Nolan's statement to the Oireachtas Joint Committee on Health followed on from the HPRA’s call last week for companies to take the necessary steps to ensure sufficient stock levels and continuity of supply of medical devices, both in the lead up to 31 October 2019 and post Brexit.
In its regulatory update published on 17 September 2019, the HPRA also outlined its own preparations in respect of supply of medical devices, which has included detailed cooperation with the Department of Health, the HSE and stakeholders.
The HPRA recently published a helpful Brexit Preparedness Checklist in conjunction with the Irish government, which encourages companies to ensure that all medical device activities are being undertaken to meet EU regulatory requirements by 31 October.
According to the checklist, companies should confirm that certification of medical devices currently certified by UK notified bodies will transfer to an EU27 notified body by 31 October. Companies should have a plan for continued certification of the devices.
The checklist also provides that companies should ensure that an authorised representative has been designated in an EU27 member state for medical devices manufactured in the UK or with UK authorised representatives, and that companies should arrange for the transfer of any UK based sponsor or legal representative to the EU/EEA for clinical investigations.
Duffy said: "In a recent medical devices newsletter, the HPRA outlined key issues relating to medical devices, including potential shortages of essential devices for patients, delay or challenges to the supply chain and notified body certification and capacity. For example, in the event of a 'no deal' Brexit, a manufacturer, authorised representative or importer of medical devices established in the UK will no longer be considered a European economic operator."
"From exit day, manufacturers based outside the EU will have to designate an EU authorised representative located within the EU27 in order to ensure continued access to the EU27 market. This EU27 authorised representative will act on behalf of a manufacturer located in a third country. Distributors established in an EU27 member state may be considered an importer of medical devices if they place the products on the EU market from the UK, which will be a third country in a no-deal Brexit. In that situation, distributors will need to be aware of specific importer obligations," she said.
Duffy said the HPRA has also indicated its willingness to discuss any specific challenges presented to stakeholders and that it has further advised anyone aware of a Brexit-related issue that could potentially affect the supply of medical devices in Ireland to inform the authority immediately.
09 Jan 2019