Notified body uk. We review medical devices and IVDs to ensure conformity to the European and UK legislations requirements. Navigate the NI market with confidence. Accreditation of Approved Bodies (GB) and UK Notified Bodies for the NI market. BSI The Netherlands (2797) is a leading full-scope Notified Body. BSI UK (0086) is a full-scope UK Approved Body. From 1 January 2021, to place a CE mark on a medical device for circulation in both Northern Ireland and the EU, manufacturers must use an EU-recognised notified body to undertake any This update uses the term conformity assessment body (CAB) to cover Approved Bodies, UK Notified Bodies (for bodies in Northern Ireland assessing to EU requirements), Recognised Third Party Designated scope - types of medical devices for which the approved body is permitted to issue UKCA certification: Medical Devices (designation expires on 16 March 2027) The government has set up a website that lists all UK Approved Bodies and UK Notified Bodies (for NI), the UK Market Conformity Assessment Bodies (UKMCAB) database, which is maintained by the Department for Business and Trade (DBT). . UKAS provides accreditation for the purposes of appointment under UK Regulations (Great Britain) and EC Directives (Northern Ireland). Learn about approved bodies and UK notified bodies that can help you ensure compliance. Accreditation of Approved Bodies (GB) and UK Notified Bodies for the NI market. ouxeyzwypiilitlqlrlyebrhmeaqrjtoschfaxvhslzxuekvrtdxyqclm