MHRA Updates Guidance on Clinical Investigations and Introduces 2026–2027 Fee Waiver Pilot
MHRA updates its clinical investigations guidance and introduces a 2026–2027 fee waiver pilot for SMEs. Key requirements for medical device manufacturers explained.
MHRA Updates Guidance on Clinical Investigations in Great Britain: Key Implications for Manufacturers
MHRA releases updated 2026 guidance on clinical investigations in Great Britain. Key regulatory impacts for medical device manufacturers under UK MDR.
Swissmedic updates guidance on clinical investigations of medical devices
Swissmedic releases updated guidance on clinical investigations of medical devices, clarifying Category A vs C studies, ISO 14155 compliance, and safety reporting requirements for manufacturers.
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.
MHRA Updates Guidance on Clinical Investigations – What Manufacturers Need to Know
The MHRA has released updated guidance for clinical investigations of medical devices in the UK, outlining new requirements for manufacturers, including application validation, safety reporting, UKCA/CE/CE UKNI considerations, and updated processes for studies in Great Britain and Northern Ireland. Medical device manufacturers must review these regulatory changes to maintain compliance, ensure timely clinical investigation approvals, and prepare robust technical documentation aligned with UK and EU regulatory frameworks.
MHRA atualiza orientações sobre investigações clínicas de dispositivos médicos
A MHRA atualizou o seu guia sobre investigações clínicas de dispositivos médicos, introduzindo novos requisitos de submissão, aprovação e monitorização no Reino Unido. A atualização, alinhada com os UK Medical Devices Regulations 2025, reforça a transparência, a rastreabilidade e a segurança dos participantes, garantindo dados clínicos fiáveis e conformidade com as Boas Práticas Clínicas (GCP).