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 1st 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.
- Chair: Andrew Davidson, MedTech SME Consultant and MediWales Director
- ABHI – Phil Brown, Director – Regulatory and Compliance
The business consequences of the MDR and IVDR
- MHRA – Celia Mortimer, Senior Regulatory Policy Manager – Devices Regulatory Policy and Ashleigh Batchen, Medical Device Regulatory Policy Advisor
Regulation of medical devices from 1 January
- Innovate UK – Michael Kipping, Innovation Lead – Biomedical Catalyst
The role of agile regulation during the COVID-19 pandemic
- Jenson – Janet Worrell, Head of Regulatory
- Acclaim Biomedical Consulting – Richard Young, Managing Director
Brexit, manufacturing and distribution – The challenges and uncertainties
This event is free to members and £125 + VAT for non-members.