UKCA for medical devices @ DQS

DQS – The Passport to the medical world (dqsglobal.com)

As part of our growth plan, DQS are establishing a United Kingdom (UK) Hub that will allow us to expand our ISO 13485 reach and add UKCA conformity assessment to our portfolio. The DQS Group already offers CE certification via our EU MDR Notified Body (0297, Germany), ISO 13485 (SCC, Canada; DAkkS, Germany), MDSAP, and TCP III.

The first step in our journey is to become an accredited certification body (Q4 2024) to offer ISO 13485 certification across the medical device supply chain. Our next step is to become designated as a UK Approved Body (Q2 2025) for medical devices. These dates align well with the current UK transitional requirements, which continue to recognize CE marking for medical devices where additional, mandatory UK requirements are met.

Our UK Hub will allow us to be closely involved in the new UK government regulatory framework and initiatives to accelerate market launch of innovative medical devices.

Now that our journey has started, we will be providing regular progress updates to keep you informed of our progress and the evolving requirements in the UK.

To find out more about the requirements for medical devices placed on the market in Great Britain and the timelines for our designation journey, join our emailing list.

If you have any questions or feedback, please email our customer support team at DQS-UK@dqs.de.