The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a public comment process on issues to be addressed in that country’s medical device regulatory framework.
According to a press release posted to the UK Government website, the 10-week public consultation seeks views from the medical device and healthcare industries, including medical practitioners, patients, and the wider public. The consultation is intended to cover a broad range of regulatory issues, including requirements for conducting clinical investigations, assessing medical device safety, importer and distributor responsibilities, and post-market surveillance activities.
The MHRA says that the public consultation on the UK’s medical device regulatory framework has been launched in the wake of the UK’s departure from the European Union, and the opportunity to create a “world-leading regime” that supports medical device innovation, streamlines the device approval process, and prioritizes patient safety.
The consultation period closes November 25th.