TÜV SÜD has secured designation as a UK Approved Body (UKAB) for medical devices, providing UKCA and CE certification for medical device manufacturers.
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 could 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 gain UKCA and CE certification simultaneously – meaning they can reduce to time to market across Europe, and potentially minimise costs.
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.
For a full list of UK Approved Bodies and their scope, visit the UK government page here.