The government of Great Britain has taken a crucial step towards supporting the continued availability of medical devices within the country by implementing the Medical Devices (Amendment) (Great Britain) Regulations 2023. These regulations allow for the acceptance of CE-marked medical devices beyond the initial deadline of 30 June 2023. The government’s intention is to ensure a smooth transition to a future regulatory framework that enhances safety and quality standards for medical devices.
Supporting a Seamless Transition
The primary objective of the Medical Devices (Amendment) (Great Britain) Regulations 2023 is to maintain the uninterrupted supply of medical devices in Great Britain. By extending the acceptance period for CE-marked medical devices, the government aims to provide regulatory stability during the transition period. This measure acknowledges the complexity of implementing a new regulatory framework and allows businesses to continue supplying medical devices without disruption while preparing for the forthcoming changes.
A Series of Statutory Instruments
The Medical Devices (Amendment) (Great Britain) Regulations 2023 is the first in a series of statutory instruments planned to implement the strengthened regulatory framework for medical devices. The Medicines and Healthcare Products Regulatory Agency (MHRA) intends to introduce additional statutory instruments in the future, including one that will establish enhanced post-market surveillance requirements. This comprehensive approach ensures that the regulatory framework evolves holistically, addressing different aspects of medical device regulation to enhance patient safety and product quality.
Timeline for the Future Framework
Core elements of the future framework for medical devices are scheduled to come into effect from 1 July 2025. However, the MHRA continues to assess feedback from external stakeholders to ensure effective and timely implementation. The timeline is subject to ongoing review, with the MHRA considering factors such as the capacity of conformity assessment bodies. This collaborative approach allows for flexibility and adjustment based on stakeholder input and evolving industry needs.
Updated MHRA Guidance
To provide clarity and guidance on the acceptance of CE-marked medical devices in Great Britain, the MHRA has updated its official guidance. The updated guidance includes an informative infographic that outlines the timelines for acceptance of CE-marked medical devices in the Great Britain market. This resource serves as a valuable reference for manufacturers, suppliers, and other stakeholders to understand and navigate the regulatory landscape during the transition period.
UKCA Marked Medical Devices
It is important to note that the regulations concerning the acceptance of CE-marked medical devices in Great Britain do not impact the requirements for UKCA-marked medical devices. The MHRA has outlined its intended position on transitional arrangements for UKCA-marked devices in Chapter 15 of the response to the consultation on future regulation of medical devices in the UK. The MHRA remains committed to collaborating with industry, trade associations, and the wider medical devices community to ensure a smooth and effective transition to the new regulatory regime.
Source: GovDot]UK
