MHRA designates three new UK Approved Bodies for UKCA certification of medical devices

30th August 2023

Yesterday, the MHRA announced that they have designated three more UK Approved Bodies for medical devices. Intertek Medical Notified Body UK, TÜV Rheinland UK and TÜV SÜD BABT now join BSI Assurance UK, DEKRA Certification UK, SGS United Kingdom and UL International (UK) in being permitted to assess and issue UKCA certification for medical devices being placed on the market in Great Britain.

This is welcome news for the industry as the designation of three new UK Approved Bodies almost doubles the existing capacity to conduct UKCA conformity assessments ahead of the CE marking transition deadlines of 30th June 2028 and 30th June 2030 (dependent on device type). The designation of EU Notified Bodies, such as TÜV SÜD, as UK Approved Bodies will also allow manufacturers to reduce costs and time to market by using the same body for both UKCA and CE marking.

The general scopes of designation for each of the UK Approved Bodies for medical devices are outlined below:

• BSI Assurance UK - medical devices under Part II of the UK MDR 2002, active implantable medical devices under Part III of the UK MDR 2002 and IVDs under part IV of the UK MDR 2002.

• DEKRA Certification UK - medical devices under Part II of the UK MDR 2002.

• Intertek Medical Notified Body UK - medical devices under Part II of the UK MDR 2002.

• SGS United Kingdom - medical devices under Part II of the UK MDR 2002 and IVDs under part IV of the UK MDR 2002.

• TUV Rheinland UK - medical devices under Part II of the UK MDR 2002 and IVDs under part IV of the UK MDR 2002.

• TUV SUD BABT - medical devices under Part II of the UK MDR 2002.

• UL International (UK) - IVDs under part IV of the UK MDR 2002.

The fully designated scope for each UK Approved Body can be found here.

If you're looking for consultancy or training support with UKCA and/or CE marking, you can get in touch with us at +44 (0)161 392 8499, via info@ivdsimplicity.com or by completing the 'Contact Us' form on our website.