News Category: Regulatory news
The HPRA, in cooperation with the Department of Health and the HSE, has been engaged in extensive Brexit planning with stakeholders across the health sector. This is to ensure, to the fullest extent possible, that the necessary preparations for any adverse impacts as a result of the UK’s departure from the EU are completed.
We are in ongoing contact with companies across the Medtech Sector industry to once again highlight particular regulatory and supply matters linked to Brexit.
In respect of regulatory compliance, detailed information is included in our June newsletter. This document highlights clearly the regulatory changes that companies need to implement in respect of issues such as the transfer of certificates from UK notified bodies to an EU-27 notified body, relocation of UK based European Authorised Representatives within the EU-27 or the designation of a European Authorised Representative within the EU 27 for UK manufacturers.
Further guidance from the European Commission is available on the HPRA Medical Devices Brexit website. This page will be updated as further guidance becomes available.
With regard to the supply of medical devices, companies are requested to take the necessary steps to ensure sufficient stock levels and continuity of supply both in the period leading up to 31 October 2019 and post Brexit. This includes consideration of stocks at in the supply chain and ensuring arrangements are in place to allow for timely replenishment of such stocks including custom requirements where applicable and allowing for potential delays during transportation.
Together with colleagues from the HSE, the HPRA continues to contact medical device manufacturers, authorised representatives as well as distributors to determine how both regulatory and supply matters relate to their product(s) marketed in Ireland, to request assurances in respect of their contingency planning, and to identify any potential issues regarding the availability of specific products associated with Brexit.
This iterative process has been ongoing for some time and will continue for the foreseeable future. This is in the context of the current assessment that there is a significant risk of a ‘no deal’ Brexit on 31 October 2019. The key goal of this review process is to focus contingency planning efforts on potentially vulnerable medical devices and to ensure that appropriate actions have been taken by suppliers of those medical devices to minimise and address any risks to continuity of supply.
We wish to acknowledge the substantial work completed to date by industry in respect of Brexit preparedness and look forward to ongoing cooperation. The HPRA remains available to discuss particular challenges presenting to stakeholders and to clarify any aspects as required.
It is absolutely critical that if you become aware of a Brexit-related issue that could potentially affect the supply of medical devices in Ireland that you inform the HPRA immediately by emailing email@example.com and we will liaise with the HSE and Department of Health on these issues.
The Brexit section of our website will keep stakeholders informed of developments related to Brexit and the health products we regulate.
Download our Brexit Preparedness Checklist