Regulatory Blog

The guidance Guide to manufacturers and notified bodies on the procedure for requesting advice from expert panels for orphan medical devices  was published on 31 March 2026 , outlining the procedural framework and expectations for applicants seeking scientific and regulatory advice. Orphan medical devices are those intended for the diagnosis, prevention, or treatment of rare conditions, where limited patient populations create challenges in generating extensive clinical evi

The UK regulatory landscape for medicines is increasingly evolving to integrate environmental protection alongside public health safety, and recently, on 1 April 2026, the UK MHRA updated its guidance on " Environmental Risk Assessments in medicines " . A key component of this approach is the requirement for Environmental Risk Assessments (ERA), ensuring that medicinal products do not pose unintended risks to ecosystems during their lifecycle. Background Environmental Risk