Clinical investigations for medical devices

AI Summary

The Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance in August 2025 regarding clinical investigations for medical devices seeking UKCA or CE markings. Under the UK Medical Devices Regulations 2002 and EU Regulation 2017/745, manufacturers must notify the MHRA at least 60 days before commencing a study. Applications are processed through the Integrated Research Application System (IRAS). For Great Britain, a 60-day assessment period follows validation, while Northern Ireland follows EU-aligned timelines. Key compliance requirements include the mandatory reporting of Serious Adverse Events (SAEs) and Quarterly Summary Reports (QSRs) via the MORE portal. Additionally, any deviations or amendments to the clinical investigation plan must be submitted for approval; failure to notify the MHRA of such changes may result in legal prosecution. Regarding financial obligations, the MHRA offers payment easements for small and medium enterprises (SMEs) and will pilot a fee waiver program for innovative devices from April 2026 to April 2027. To maintain authorization, sponsors must ensure all fees are paid in full, as outstanding balances will lead to the revocation of study approval. Organizations must also report any early study terminations or temporary halts within specified timeframes to ensure continued regulatory compliance.