MHRA has updated its guidance on submitting clinical investigation proposals, covering GB and Northern Ireland requirements, IRAS submission, supporting documentation, fees, device evidence, software, biological safety and sterilisation.

Team-NB has published a position paper calling for broader notified body access to EUDAMED and related regulatory systems to support risk-based surveillance under the MDR and IVDR.

Team-NB has highlighted the need for broader notified body access to EUDAMED vigilance, clinical investigation and performance study data to support proportionate risk-adaptive surveillance under the MDR and IVDR.

ISO 14155:2026 specifies good clinical practice for the design, conduct, recording and reporting of clinical investigations of medical devices involving human subjects.

The MHRA has updated its guidance on clinical investigations for medical devices, covering notification requirements, fees, applications, assessment, amendments, reporting and Northern Ireland requirements.

The European Commission and EU Member States have launched the second phase of the COMBINE pilot programme, expanding coordinated assessment to additional types of combined clinical trials involving medicines and medical devices.

Swissmedic has updated its information sheet on clinical investigations of medical devices, including approval procedures, ISO 14155, category C investigations, reporting duties and IMDRF adverse event terminology.

The MHRA has updated its guidance on clinical investigations for medical devices, including applications, assessment timelines, amendments, reporting requirements and fee waiver information.

The MDCG has published MDCG 2024-10, providing guidance on the clinical evaluation of orphan medical devices, including recommendations on clinical evidence generation, study design, post-market clinical follow-up and benefit-risk assessment under the MDR.

MedTech Europe has responded to the EDPB consultation on the proposed DPIA template, calling for greater flexibility and warning against additional compliance burdens for medical device and digital health manufacturers.

MHRA updates its clinical investigations guidance and introduces a 2026–2027 fee waiver pilot for SMEs. Key requirements for medical device manufacturers explained.

MHRA releases updated 2026 guidance on clinical investigations in Great Britain. Key regulatory impacts for medical device manufacturers under UK MDR.

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.

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.

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.

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).