In September 2025, the MHRA published harmonised guidance and validation checklists for sponsors and investigators planning clinical investigations in the UK. The document also covers specific procedures for Northern Ireland.

New regulatory framework – what has changed?

Key updates include:

  • application timeline – applications must be submitted at least 60 days prior to study initiation,
  • integrated IRAS system – the Integrated Research Application System processes applications electronically for both MHRA and ethics committees,
  • harmonised checklists – sponsors must use new validation lists to confirm completeness,
  • enhanced reporting – emphasis on transparency in statistical data and safety analysis.

Human factors engineering

MHRA requires explicit inclusion of usability engineering in study design. Sponsors and manufacturers must demonstrate assessment of product usability, user–system interaction, and risks linked to operational errors. This involves:

  • usability reports,
  • hazard analysis from the user interface,
  • evaluation of error-related impacts on safety and performance.

This reflects MDR Annex I (points 5 and 14), which mandates design that minimises risks from real-world use, including user errors.

Stricter reporting obligations

MHRA now requires:

  • statistical reports including raw data,
  • electronic data retention throughout the study lifecycle,
  • compliance with ISO 14155:2020,
  • mandatory SAE reporting linked to corrective actions.

Links to MDR and ISO 14155
Although the UK is outside the EU, MHRA guidance closely aligns with MDR:

  • Articles 62–82 MDR govern clinical investigations, ethical review, and participant protection,
  • Annex XIV MDR on clinical evaluation is reflected in MHRA’s requirements,
  • ISO 14155 is explicitly referenced as the global GCP standard for device trials.

Practical consequences

Sponsors and manufacturers  should:

  • adjust study planning timelines,
  • update QMS procedures to cover human factors assessments,
  • prepare comprehensive statistical datasets and archiving systems,
  • strengthen collaboration with investigators and ethics committees.

Conclusion

The new MHRA guidance shows the UK’s commitment to maintaining high clinical standards while harmonising with global frameworks. For manufacturers, this means stricter requirements in safety, usability and data transparency. Ultimately, the goal is greater patient safety and reliability of clinical evidence.