Thursday morning’s daily update from the MHRA contained what promised to be an exciting update regarding UK Approved Bodies for medical devices.
UK Approved Bodies are responsible for conducting conformity assessments on medical devices under the UK’s new UKCA conformity assessment scheme. At present there are only three UK Approved Bodies: BSI, SGS and UL. These were the three UK-based Notified Bodies under the EU medical device regulatory framework which have been grandfathered in to the new UK scheme.
As these three UK Approved Bodies do not have the capacity needed to conduct conformity assessments on all new medical devices which will require UKCA conformity assessment, the MedTech sector is waiting with bated breath for news that new UK Approved Bodies have been appointed.
There were rumours that one (or possibly two) existing EU Notified Bodies might obtain UK Approved Body status for their UK-based sister companies before the end of 2021.
Sadly, those rumours have not yet become reality: the update from the MHRA was simply a change in the administrative details of one of the three legacy bodies.
So, as we emerge into Spring 2022, the MedTech sector continues to face a profound bottleneck in obtaining UKCA marks.
We await the outcome of the UK government’s consultation on a 2023 update to the UK’s medical devices regulatory framework. The new framework is likely to be transformative over the current framework and could require the majority of existing medical devices on the UK market to have to undergo conformity assessment again. As a result, there is significant work coming down the pipeline for UK Approved Bodies.
We can only hope that the UK government takes into account the UK Approved Body capacity bottleneck and plans for it in advance – unlike the European Union which has now twice been forced into last-minute amendments to its new medical device regulatory frameworks in order to avert crises in the supply of life-saving MedTech.
Read the latest update here: “MHRA designates fourth UK Approved Body for medical devices“