Dive Brief:
- The UK Association for Medical Device Approved Bodies, or Team AB, formally launched in London on Monday with the aim of helping industry participants navigate new regulatory requirements.
- Team AB will represent U.K.-approved bodies for medical devices and in vitro diagnostics (IVDs) in their dealings with the Medicines and Healthcare products Regulatory Agency (MHRA), which regulates the U.K. medical devices market, as the agency works to create a post-Brexit framework for the sector.
- The group will provide a forum for applicants and designated approved bodies to share experiences and facilitate consistency in regulatory understanding and feedback, given the anticipated evolution of U.K. medical device regulations, according to Team AB.
Dive Insight:
New medical device regulations are under development in the U.K. after Great Britain did not adopt the European Union’s delayed Medical Devices Regulation.
The MHRA unveiled its own proposed regulatory framework for medical devices and IVDs and subsequently extended the period for implementing the new rules until July 2024.
In January, the agency provided an updated roadmap in which it said it plans to have core elements of the new framework for medical devices established in 2025, after priority measures to protect patient safety are put in place this year.
The U.K.’s approved bodies are organizations designated by the MHRA to assess whether manufacturers and their medical devices meet requirements set out in the medical devices regulations.
In addition to working with the MHRA, Team AB will represent U.K. approved bodies in dealing with other U.K. government departments, the European Commission, industry associations and the media, the group said.
“At a time when the U.K. regulatory landscape is evolving and expecting to undergo significant changes, Team AB will offer an opportunity to bring consistency of interpretation of requirements across Approved Bodies that will benefit manufacturers and patients alike,” Monisha Phillips, co-president of Team AB, said in a statement.
The founding members of Team AB are BSI Assurance, DEKRA Certification, DNV Business Assurance, DQS Medizinprodukte, Intertek Medical Notified Body, LNE-GMED, Scarlet NB, SGS United Kingdom, TUV Rheinland, TÜV SÜD BABT and UL International.
