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Regulating medical devices in the UK What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets. From: MHRA) is responsible for regulating the UK medical devices market. This guidance provides information on the UK system, including for: getting your device certified MHRA This guidance is divided into sections on the different rules that apply in Great Britain, Northern Ireland and the EU. Great Britain is England, Wales and Scotland. For Northern Ireland, different rules apply to those in Great Britain. For more information on the regulatory system for medical devices in Northern Ireland, please see Regulation of medical devices in Northern Ireland below.

United kingdomNorthern irelandGreat britainCompetent authorityVitro diagnostics associationAssociation of great britainCustomer services centreRegulatory agencyEu competent authorityAssociation of british healthtech industriesNotified bodiesUnited kingdom notifiedKingdom notified bodiesUnited kingdom approvedNorthern ireland based authorised representativesUnited kingdom responsible person