The agency’s consultation on the post-Brexit regulatory framework for medical devices and diagnostics aims to support innovation and sustainability, among other goals.
A 10-week consultation launched by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on the future regulation of medical devices, including in vitro diagnostics (IVD), will close on 25 November 2021 at 11:45 p.m. GMT.
The backdrop for the consultation is the UK Medicines and Medical Devices Act 2021 (the Act), which came into force on 11 February 2021 and paved the way for new regulations to shape the post-Brexit landscape for medicines and medical devices in the UK. The Act introduced extensive delegated powers in favour of the Secretary of State or an “appropriate authority” to amend or supplement regulations in the area of human medicines and medical devices.
This Client Alert analyses the most substantive proposed changes and includes an Appendix that provides a detailed summary, as well as commentary on whether the proposal aligns with or diverges from the EU regulatory framework.