To ensure that UKCA and CE certification remains seamless for UK manufacturers, TÜV SÜD has secured designation as a UK Approved Body (UKAB) for medical devices. It is the first UKAB to achieve such a wide designation scope for general medical devices after progressing through the full initial designation application process.
UKABs are responsible for conducting medical device conformity assessments under the UKCA scheme, which allows manufacturers to market their products in the UK. TÜV SÜD’s UKAB designation will help to relieve some market pressure, as the industry is concerned by the lack of capacity to conduct UKCA medical device conformity assessments ahead of Government deadlines. TÜV SÜD’s UKAB accreditation also means that medical device manufacturers can minimise costs and time to market across Europe for new products by gaining UKCA and CE certification simultaneously.
Monisha Phillips, Head of UK Medical and Health Services (MHS) Certification Body at TÜV SÜD, said: “Our designation with an almost full scope for general medical devices mirrors TÜV SÜD Germany’s EU Notified Body scope. This will allow our medical devices clients to be fully supported for EU and UK market access, so they can optimise efficiencies. As the UK’s Medical Device Regulations will only accept CE marked general medical devices on the Great Britain market until 30 June 2028 and 2030 (dependent on device type), the medical device market is under pressure to get medical devices transitioned to UKCA certification in just five years.”
TÜV SÜD is a designated UKAB for Part II of the UK Medical Devices Regulations 2002 (SI 618, as amended) for General Medical Devices. Full details of the scope of designation can be accessed here: https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies/uk-approved-bodies-for-medical-devices