UKCA and Medical Devices

Do you understand the requirements?

Do you understand the requirements?

For manufacturers placing medical devices on the UK market there is an extended transition period to 30th June 2023. With less than 2 years to go before the UKCA mark becomes mandatory for medical devices, manufacturers should act now to understand the requirements and routes to conformity for The Medical Devices Regulations 2002 (SI 2002 N 618, as amended) (UK MDR).

This webinar will provide general guidance to medical device manufacturers on UKCA marking with focus on medical device specific requirements to provide clarity on the next steps required to maintain UK market access after June 2023.

Key points covered:

  • Where are we now?
  • General guidance on the UKCA
  • Guidance on medical device UKCA conformity assessment processes
  • What next?

About the Speaker

Dr. Monisha Phillips
Head of MHS Certification Body (UK)

Monisha has over 20 years of experience in medical devices including regulatory conformity assessments, quality assurance, biomaterials research and medical device development.

Next Steps

Site Selector