The MHRA published an announcement on the future regulation of medical devices. There will be an extension of the standstill period.This includes a twelve-month extension to the current standstill period with the aim to bring the new regulations into force in July 2024. Before the regulations come into force, the draft regulations will be published by the World Trade Organisation allowing key stakeholders to review and comment on the draft for at least 60 days.
The MHRA intends to introduce legislation by Spring 2023 that will bring into force the transitional arrangements and post market surveillance activities, as outlined in the Governments Response on June 26th, 2022.
Below is the official announcement letter from the MHRA.
The decision is also communicated through the MHRA’s website on 25 October 2022: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations.
Read more about the transitional arrangements and post market surveillance requirements here: https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom.