Uk – UK approved bodies launch Team-AB as MHRA gears up for new medtech legislation

Approved bodies (AB) in the UK have come together to launch the UK Association for Medical Device Approved Bodies (Team-AB). It plans to lobby the government and Medicines and Healthcare products Regulatory Agency (MHRA), as it develops new medical device regulations this year.

On 19 February, a group of approved bodies in the UK announced the formation of Team-AB with the aim of speaking with one voice when it comes to developing new medical device regulations in the UK. The current, UK Medical Device Regulations 2002, based on the EU Medical Device Directives (MDD), is set to undergo a major update that is expected to go into effect in 2025.

As the EU MDD is being replaced by the Medical Device Regulation (MDR), the UK government passed legislation in 2021 to also update its 2002 regulations. That has led to extensive consultations with the medtech industry, approved bodies, and other stakeholders. This year, MHRA is expected to develop draft language for a new bill that would bring British regulations closer in line with the MDR…