The MHRA has appointed two new UK Approved Bodies for medical devices, namely the UK affiliates of EU Notified Bodies TÜV Rheinland and TÜV SÜD. The former has also been designated as an Approved Body for in vitro diagnostic medical devices (IVDs). This means there are now six UK Approved Bodies capable of conducting UKCA conformity assessments for general medical devices.

The last organisation to be designated as an Approved Body was the UK affiliate of DEKRA almost a year ago. Prior to this, the only other UK Approved Bodies were three UK-designated Notified Bodies under the EU medical devices framework that had automatically converted to UK Approved Bodies following expiry of the Brexit transition period.

Industry had been expecting the appointment of a couple more UK Approved Bodies for some time and this is a welcome addition to the current fairly thin bench.

The update also follows the UK MDR[1] amending legislation coming into force on 30 June 2023, which extended the transitional periods in the UK MDR. The deadlines for CE marked medical devices and IVDs to be commercialised in Great Britain (GB) have thus been extended to:

• 30 June 2028  for ‘legacy’ medical devices which have been CE marked in accordance with the EU MDD[2] or the EU AIMDD[3]; and
• 30 June 2030 for medical devices which have been CE marked in accordance with the EU MDR[4], and ‘legacy’ IVDs which have been CE marked in accordance with the EU IVDR[5] or the EU IVDD[6].

The increase in capacity to conduct UKCA conformity assessments will be welcome news for other UK Approved Bodies which, combined with the longer transition periods, will help clear the bottleneck to obtaining a UKCA mark. However, similar to when DEKRA’s UK affiliate was announced as an Approved Body, we expect the new Approved Bodies to primarily use its UK designation to issue certificates allowing UKCA marking to its existing customers in the short term.

We are waiting with bated breath for a draft of the UK’s new regulatory framework for medical devices, which is intended to apply from 1 July 2025.[7] We understand that a number of topics remain open in the new regulatory framework, and we have speculated about the future of the UKCA mark in a recent article. In any event, additional Approved Body capacity is welcome to help ensure medical devices on the GB market are UK-compliant.

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[1] Medical Devices Regulation 2002

[2] Medical Device Directive 93/42/EC

[3] Active Implantable Medical Device Directive 90/385/EEC

[4] Medical Device Regulation (EU) 2017/745

[5] In Vitro Diagnostic Medical Device Regulation (EU) 2017/746

[6] In Vitro Diagnostic Medical Device Directive 98/79/EC

[7] Implementation of the Future Regulations