Clinical investigations in Great Britain

AI Summary

The Medicines and Healthcare products Regulatory Agency (MHRA) provides this guidance for manufacturers conducting clinical investigations for medical devices in the United Kingdom. The regulatory framework differs by region: Great Britain follows the Medical Devices Regulations 2002 (UK MDR), while Northern Ireland adheres to the EU Medical Device Regulation (EU MDR) and EU In Vitro Diagnostic Medical Device Regulation (EU IVDR). For investigations involving sites in both regions, the EU MDR standards apply. Manufacturers must notify the MHRA at least 60 days before starting an investigation for any device that does not carry a UKCA or CE mark, especially for high-risk Class III or implantable devices. Required actions include submitting applications via the Integrated Research Application System (IRAS) and obtaining a favorable opinion from a UK Research Ethics Committee (REC). During the study, manufacturers are strictly required to record all adverse events and report serious adverse events (SAEs) immediately through the MHRA’s MORE portal. Furthermore, they must submit quarterly safety summary reports and provide a final clinical investigation report within one year of the study's conclusion. Significant modifications to the study protocol or the device itself require additional notification and approval. The MHRA retains the authority to object to, suspend, or terminate investigations on the grounds of public health or safety, and failure to comply with these notification requirements is considered a criminal offense.