In a bid to boost its certification capacity for medical devices in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has designated three new UK Approved Bodies.
The move, which almost doubles the agency’s current roster, sees TÜV SÜD, Intertek, and TÜV Rheinland UK join existing bodies BSI Assurance UK, DEKRA Certification UK, SGS United Kingdom and UL International.
The role of an approved body is to conduct conformity assessments on medical devices submitted by manufacturers for the Great Britain market.
Focus on approved bodies intensified following Britain’s legislative cut-off from Europe during Brexit. There has been a toing and froing of regulatory acceptance since the MHRA became the overseer of whether medical devices were approved for the British market.
The UK government had given an extended timeframe in which CE-marked devices could be placed on the British market. And despite recent concessions in other industries such as toys and radios, makers of medical devices still have a grace period until 30 June 2028 or 30 June 2030 depending on which EU directive their device falls under.
The addition of three new UK Approved Bodies aims to bolster UKCA certification capabilities ahead of the CE-mark transition deadline.
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By GlobalDataTÜV SÜD and Intertek have both been designated to assess and certify general medical devices. TÜV Rheinland UK has also been designated to assess and certify in-vitro diagnostics, as well as general medical devices.
Dr Laura Squire, MHRA Chief Healthcare Quality and Access Officer said: “By almost doubling capacity for medical device assessment in the UK, we’re supporting patients to access the safe and effective products they need to protect their health.”
“Approved Bodies play a critical role in the supply of medical devices and expanding capacity has been a key priority for us to support manufacturers to bring their products to the UK.”
In an email sent to Medical Device Network, Jacqueline Mulryne, partner at London law firm Arnold & Porter, said: “It is a positive move for industry to see three more approved bodies that can undertake medical device UKCA conformity assessment procedures. This will help with capacity issues and ensure companies can keep their devices on the UK market. It is also encouraging to see EU Notified Bodies being designated as UK Approved Bodies, as it demonstrates confidence in the UK system. This should make it easier for companies that use these Notified Bodies in the EU, as they should be able to use the same body in the UK.
“However, a bigger concern for industry is the new medical devices legislation, when this will be put in place, what requirements will need to be met, and the continued recognition of the EU CE marks. The uncertainty around the future legislation in the UK and how – and whether – the UKCA will apply, means companies are finding it difficult to plan their activities for the UK market.”
Editor’s note: This article was updated to include comments from Jacqueline Mulryne.
