MHRA Extension
🔹 The UK government plans to reform the current regulatory framework for medical devices with a phased approach, aiming for core aspects to apply from 1 July 2021
🔹 Legislation in Spring 2023 will extend the acceptance of CE marked medical devices on the Great Britain market, easing the transition to the future frameworkrk
🔹 Pending Parliamentary approval, CE marked medical devices can be placed on the Great Britain market up to certain dates, allowing these devices to remain on the market
🔹 Strengthened post-market surveillance requirements will be introduced in legislation later in 2023, expected to apply from mid-2024, prioritizing patient safety.
🔹 Future amendments will restrict reliance on EU MDR or EU IVDR CE certificates renewed after the future regime fully applies (from 1 July 2025) for placing medical devices on the market.
🔗 Original Document : https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations
