First UKMDR (UK Medical Devices Regulations) certificate Issued by TÜV SÜD

3 June 2024

TÜV SÜD is proud to announce that we have issued our first UKMDR (UK Medical Devices Regulations) certificate. This marks a significant milestone for us since becoming an Approved Body (UKAB) for medical devices in August 2023 with an extensive designation scope for medical devices (UKMDR 2002 Part II) and active implantable devices (UKMDR 2002 Part III). This achievement positions TÜV SÜD at the forefront of facilitating seamless UKCA (UK Conformity Assessment) and CE certification for medical device manufacturers in the UK.

The certificate was issued to Devicor Medical Products, Inc. (Mammotome), a manufacturer of breast biopsy and surgical solutions. Jack Cummings, Director of Quality and Regulatory Affairs, commented:

"TÜV SÜD's expertise and efficiency have been instrumental in navigating the complex landscape of medical device certification. Their support has not only expedited our compliance process, but also underscored their dedication to customer satisfaction. We look forward to continuing our partnership as we navigate evolving regulatory requirements."

Dr Monisha Phillips, Head of UK Medical and Health Services (MHS) Certification Body at TÜV SÜD, enjoyed working on TÜV SÜD’s first UKMDR project:

"Navigating the complexities of medical device compliance for Mammotome has been both challenging and rewarding. I’ve enjoyed leading our team through this project, and witnessing the positive impact our efforts have on facilitating a smoother UKCA and CE certification process for Mammotome since becoming a UK Approved Body (UKAB) for medical devices."

Our UKAB designation addresses industry concerns over capacity constraints hindering medical device conformity assessments, offering a timely solution as the deadline for transitioning to UKCA certification approaches. Monisha emphasised the strategic significance of our almost full scope for general medical devices, aligning with TÜV SÜD Germany's EU Notified Body scope. This alignment streamlines market access for clients in both the EU and the UK, minimising certification costs and enhancing efficiency.

As the UK’s Medical Device Regulations will only accept CE marked general medical devices on the Great Britain market until 30 June 2028 and 2030 (dependent on device type), the medical device market is under pressure to get medical devices transitioned to UKCA certification in just five years. TÜV SÜD's role as a designated UKAB for Part II and Part III of the UK Medical Devices Regulations 2002 positions us as a pivotal player in the evolving landscape of medical device compliance.

Do you need support with securing UKCA and CE certification for medical devices? Please contact us to see how we can help or find out more about our healthcare and medical device sector services.

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