The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on software (including artificial intelligence [AI]) regulated as medical devices.
Following the European Commission’s 6 January vote to extend the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) transition period, the European Parliament (EP) adopted the proposal on 16 February 2023.
The UK Government has published its Medical Technology Strategy policy document, designed to ensure that the health and social care system can access safe, effective and innovative medical technologies.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has extended the designation of UL International UK Ltd as an Approved Body.
Fears of a shortage of medical devices have led the European Commission (EC) to adopt a proposal to extend the transition period to new rules under the Medical Devices Regulation. The proposal was made at the EPSCO Council meeting on 9 December 2022 by EU health ministers.
The Regulatory Affairs Professionals Society (RAPS) reports that the European Council supports a proposal made by the European Commission to delay the transitional deadlines for medical devices under the MDR.
The National Institute for Health and Care Excellence (NICE) plans to speed up its processes for evaluating lower-risk treatments using a lighter touch approach. This will free up time to consider the increasing number of more complex applications. NICE states that this method will make its assessments faster, enabling quicker access to promising new treatments.
Many thanks to LBIC and Lucy Garnsworthy for featuring PharmaMedic’s insights on recent UK government initiatives to support pharma and medicaldevices regulatory innovation in its winter newsletter. The article features on page 6 of the newsletter.
