Clinical Workshop Resources
The MVLS Translational Research Initiative (TRI) provides support and guidance to a variety of translational projects throughout the college.
Our team is aiming to provide access to critical resources and information to support research progression, through a variety of informational and practical workshops. Our online pages feature a variety of resources, based on our previously organised events.
For more information, please contact the Translational Clinical Research Officer, Dr Michaela Petaroudi.
Changes in the regulations of Medical Devices post-Brexit
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market. They perform market surveillance of medical devices and are responsible for regulating the marketing and supply of devices in the UK.
Since 1 January 2021, there have been a number of changes, introduced through updates in legislation, to how medical devices are regulated and placed on the market in Great Britain (England, Wales and Scotland).These updates are still underway, as the legislators are working to shape the future legislation for medical devices aiming to deliver improved patient and public safety; greater transparency of regulatory decision-making medical device information; close alignment with international best practice; and more flexible, responsive and, proportionate regulation of medical devices.
In collaboration with the Medical Research Council (MRC UK) Regulatory Support Centre, the TRI provide resources to help researchers navigate the current updates and changes in the MHRA regulations of Medical Devices, post-Brexit. The event, run on the 20th of October 2022, focused on the currently published updates, and future expected regulatory changes, based on government communications.
CHANGES IN THE REGULATIONS OF DIGITAL DATA POST-BREXIT
On 28 June 2021, the EU approved adequacy decisions for the EU GDPR and the Law Enforcement Directive (LED). This allows continued data flow without major changes in the majority of circumstances. Both decisions are expected to last until 27 June 2025.
The General Data Protection Regulation has been kept in UK law as the UK GDPR.
This guidance is aimed at UK businesses who receive data from, or have offices in the EU and European Economic Area (EEA) and gives a basic overview of the changes to data protection since the UK left the EU and now has an approved adequacy decision.
The TRI-organised workshop on the 20th of October 2022, featured a presentation by the MRC Regulatory Support Centre, featuring an overview of the UK Data Protection law and possible changes post-Brexit, as well as practical applications of the law in health research.
Updates in the regulation of Medial Devices
For more information on the current updates in legislation, visit the MRC regulatory support centre, or get in touch: rsc@mrc.ukri.org