Self-Care Devices Will Need New UKCA Mark Post-Brexit
Self-care medical devices sold in Great Britain post-Brexit will require a new UKCA certification mark, which importantly will not be recognized in the EU, EEA or Northern Ireland, requiring manufacturers to navigate two separate regulatory systems.
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UK consumer health industry association PAGB says it is "relieved" a last minute post-Brexit deal has been struck, which will enable its members to continue to supply OTCs to the EU with limited disruption.
Companies supplying into Northern Ireland now have more time to prepare for post-Brexit regulatory changes in areas like batch testing, imports and Falsified Medicines Directive requirements. UK industry association, PAGB, in a joint statement with five other pharmaceutical industry associations, including AESGP, describes it as a step in the right direction, but also warns that there is still much work to do.
The AESGP welcomes the European Commission's decision to delay the EU Medical Devices Regulation compliance deadline by one-year, and calls for a rapid increase in the number of notified bodies and the development of guidance documents.