Application Guide: TÜV SÜD BABT Medical Device Certification

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Application Guide and Checklist for TÜV SÜD BABT Medical Devices certification

To ensure that UKCA and CE certification remains seamless for UK manufacturers, TÜV SÜD has secured designation as a UK Approved Body (UKAB) for medical devices. We are the first UKAB to achieve such a wide designation scope for general medical devices after progressing through the full initial designation application process.

“Our designation with an almost full scope for general medical devices mirrors TÜV SÜD Germany’s EU Notified Body scope. This will allow our medical devices clients to be fully supported for EU and UK market access, so they can optimise efficiencies. 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.”

Monisha Phillips, Head of Approved Body for Medical Devices at TÜV SÜD

To help you ensure that you provide the correct documentation at the appropriate time, we've created our "Application Guide for TÜV SÜD BABT Medical Devices Certification."

In this guide, you'll find a helpful overview of each stage and guidance from our experts with a checklist of requirements to help your medical device certification go smoothly. You'll learn about the requirements for:

  • Pre-application
  • Application review
  • Conformity assessment

Want to sell your medical devices in the UK? 

Download our application process checklist for applying for UKCA certification for medical devices now.

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