MHRA Regulatory Advice Meetings: Updated Guidance for Medical Device Manufacturers
The MHRA has published updated guidance on how manufacturers can request regulatory advice meetings for medical and IVD devices in the UK. This service helps clarify complex regulatory questions but excludes product-specific consultancy. Discover fees, scope, limitations, and how to apply.
MHRA Publishes Updated Guidance on Clinical Investigations for Medical Devices: Key Implications for Manufacturers
The MHRA has published updated guidance on clinical investigations for medical devices, detailing the requirements manufacturers must meet when planning and conducting investigations in Great Britain. The update strengthens documentation expectations, safety requirements and regulatory oversight, making it essential for all manufacturers preparing UK submissions.