MORE platform API (Application Programming Interface) set up - user reference guide

AI Summary

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a technical user guide for the Manufacturer's Online Reporting Environment (MORE) platform. While the provided text does not reference a specific company, inspection dates, or violations typical of an enforcement letter, it establishes the operational requirements for compliance with UK medical device reporting regulations. The guidance focuses on the regulatory framework governing the electronic submission of vigilance reports and adverse event data. The document outlines essential technical actions required for manufacturers to maintain regulatory standing. Specifically, organizations must complete a formal registration process to gain access to the MORE portal. Technical teams are instructed on the setup of an Application Programming Interface (API), which facilitates the automated transfer of data from corporate systems to the regulator. A critical requirement identified is the validation of reports within the production environment to ensure that submissions meet data formatting standards and avoid transmission failures. By adhering to these procedures, manufacturers fulfill their legal obligations to report safety issues, thereby supporting the MHRA's oversight of medical device performance and public safety. This guide serves as a foundational resource for regulatory affairs and IT departments tasked with implementing secure and compliant reporting workflows within the UK market.