Medical Device and Diagnostics Regulatory Event

Mae’r cynnwys hwn wedi dod o wefan allanol ac mae ar gael yn Saesneg yn unig.

There are significant changes in the Regulatory requirements for Medical Devices and Diagnostics from the EU Directives and also the new UK Conformity Assessment (UKCA) mark. From 1 January 2021, the UKCA well be available for devices on the Great Britain market and the mark will be mandatory from June 2023.

This MediWales event will bring together experts to discuss regulatory strategy, and post-Brexit regulation for developing and distributing health technologies. Practical elements will be examined such as the UKCA mark, how this route interacts with Europe and the actions companies need to undertakes to ensure compliance.

You will hear from the following speakers who will provide their expert opinions and share their insight and advice on the new requirements.

Speakers:

• Chair -  Andrew Davidson, MedTech SME Consultant and MediWales Director
• Medical and Healthcare outcomes Regulatory Agency – Celia Mortimer, Senior Regulatory Policy Manager – Devices Regulatory Policy
• Association of British Health Tec industries – Phil Brown, Director – Regulatory and Complianc
• Acclaim Biomedical Consulting – Richard Young, Managing Director