Introducing Team-AB: The UK Association for Medical Device Approved Bodies
On 19 February 2024, UK Approved Bodies and those undergoing the designation process made a groundbreaking announcement with the foundation of Team-AB. This new organization represents UK Approved Bodies in their interactions with key stakeholders, including the Medicines and Healthcare products Regulatory Agency (MHRA), industry trade associations, and other stakeholder groups where a combined effort is beneficial.
Team-AB aims to provide a forum for applicant and designated Approved Bodies to share experiences, discuss pertinent topics, and enable a united voice for medical device UK Approved Bodies. This collaborative effort is designed to facilitate consistency in regulatory understanding and feedback to stakeholders in the coming years, especially given the anticipated evolution of the UK Medical Device Regulations.
Dr. Monisha Phillips, head of Approved Body at TÜV SÜD, and Mr. Vishal Thakker, head of UK Approved Body at BSI, have been appointed as co-presidents of Team-AB for 2024 and will lead the organization through its first year. Dr. Phillips expressed her excitement and honor in being involved in the creation of this group, emphasizing the opportunity to bring consistency of interpretation of requirements across Approved Bodies that will benefit manufacturers and patients alike. Mr. Thakker highlighted the importance of supporting the MHRA and the medtech industry in the everchanging UK regulatory landscape, emphasizing the aim of bringing safe and effective medical devices to the UK market in a harmonized approach.
With the formation of Team-AB, the UK medical device sector is poised to address new challenges and opportunities presented by the evolving regulatory landscape. The founding members of Team-AB include prominent organizations such as BSI Assurance UK Ltd, DEKRA Certification UK Ltd, DNV Business Assurance UK Limited, and others.
Dr. Laura Squire OBE, chief healthcare quality & access officer at MHRA, expressed her delight in the formation of Team-AB, recognizing the importance of consistency and clarity of requirements for the medical device industry to ensure the right products reach UK patients when they need them.
Team-AB represents a significant step forward in unifying the efforts of UK Approved Bodies and those undergoing the designation process. It provides a platform for collaboration and knowledge sharing, ultimately working towards the common goal of ensuring the safety and effectiveness of medical devices in the UK market.
For more information about Team-AB, you can visit their LinkedIn page.
