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Approved Bodies for certifying medical devices form Team-AB

A new group has been formed by the UK Approved Bodies for certifying medical devices, with 11 companies joining forces as Team-AB (The UK Association for Medical Device Approved Bodies).

In recent years, the UK Regulatory landscape has been in a state of flux, presenting new challenges and opportunities for the entire medical device sector. Throughout this time, UK Approved Bodies (and those undergoing the designation process) have worked tirelessly to support this development. In late 2023, a decision was made to bring this group of organisations together to officially form Team-AB (The UK Association for Medical Device Approved Bodies).

In August 2023 the Medicines and Healthcare products Regulatory Agency (MHRA), appointed three new UK Approved Bodies, bringing the total to seven, to enable faster certification of safe and effective medical devices for healthcare professionals and the public in accordance with Part II of the UK Medical Devices Regulations 2002

Team-AB will represent UK Approved Bodies in their dealings with key stakeholders, including: the MHRA, industry trade associations and other stakeholder groups where a combined effort is beneficial. Team-AB will provide a forum for applicant and designated Approved Bodies to share experience, discuss pertinent topics and enable a united voice for medical device UK Approved Bodies. This is key to facilitate consistency in regulatory understanding and feedback to stakeholders in the coming years, given the anticipated evolution of the UK Medical Device Regulations (MDR).

Dr Monisha Phillips, Head of Approved Body at TÜV SÜD and Mr Vishal Thakker, Head of UK Approved Body at BSI, have been appointed co-Presidents of Team-AB for 2024 and will lead the organisation through its first year.

Dr Monisha Phillips, Head of Approved Body at TÜV SÜD and Co-President of Team AB, said: “At a time when the UK 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. I am excited and honoured to be involved in the creation of this group.”

 Founding members of Team-AB are:

  • BSI Assurance UK Ltd
  • DEKRA Certification UK Ltd
  • DNV Business Assurance UK Limited
  • DQS Medizinprodukte UK Ltd
  • Intertek Medical Notified Body UK Ltd
  • LNE-GMED UK Ltd
  • Scarlet NB UK Ltd
  • SGS United Kingdom Limited
  • TUV Rheinland UK Ltd
  • TÜV SÜD BABT Unlimited
  • UL International (UK) Ltd
  • Kiwa UK Ltd

For contact and enquiries, please see the dedicated Team-AB LinkedIn page: https://www.linkedin.com/company/teamab/

Dr Laura Squire OBE, Chief Healthcare Quality and Access Officer at MHRA, said: “The growth in Approved Body capacity is great news but it does make the job of ensuring consistency a little harder. I am delighted therefore, to see the formation of Team AB. We are at a point of real opportunity in the UK - we know that consistency and clarity of requirements matters to the medical device industry and is essential for ensuring the right products get to UK patients when they need them. I really look forward to working together with Team AB to achieve that goal.”

For further information on UK approved bodies, please click here: https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies

 

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