If you are an Irish undertaking producing or exporting medical devices into the European Union or you are simply willing to extend your market, this article is for you.
It is a fact that the Irish Health Products Regulatory Authority is in close cooperation with its correlative Department of Health to plan, alongside stakeholders from the health sector, solutions against an eventual Brexit.
Nobody knows how long this situation will go on, but uncertainty is a fact for those affected. Regulatory changes will become a reality for companies in case of no deal Brexit. Some examples being: the transfer of certificates from the UK Notified Bodies to European equivalents, the relocation of UK based European Authorised Representatives within the remaining Union or the designation of new representative within the EU for UK manufacturers. Find more up-to-date info about it on the Medical Devices Brexit website.
Another relevant issue pops up concerning the supply of medical devices. Companies are requested to ensure sufficient stock and continuity of supply during the transition. This is certainly not as simple as it might appear to be. Supply chains well-being shall be secured, guaranteeing enough time for its replenishment, including associated custom requirements and backing up potential delays during transportation of commodities. To this end, the Irish Competent Authorities[1] are trying to ensure that medical device suppliers carry out appropriate measures to minimize and address any risks to continuity of supply.
At this very moment, the Irish HPRA is in permanent contact with medical device manufactures, Authorized Representatives and distributors giving advice on both regulatory and supply matters. When facing issues, you can immediately contact the HPRA by emailing to devices@hpra.ie or you could always take a look at the Brexit preparedness checklist which was issued in this regard.
Carlos Francisco Marín Barrios
Regulatory Affairs and Quality Assurance
26th November 2019
[1] HPRA., “Brexit Regulatory and Supply Preparedness – Medical Devices” (September 2019) Available at: http://www.hpra.ie/homepage/medical-devices/news-events/item?t=/brexit-regulatory-and-supply-preparedness-medical-devices&id=93670c26-9782-6eee-9b55-ff00008c97d0
Obelis can provide you with a top-notch assistance to avoid unnecessary adverse impacts to the fullest extent possible in case of Brexit. For further information contact our experts.
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