Digital Safety Reporting for Medical Device Manufacturers in the UK

1. Purpose of MORE

The Manufacturer’s Online Reporting Environment (MORE) is an online system developed by the Medicines and Healthcare products Regulatory Agency (MHRA) to support the electronic submission of medical device vigilance reports in the UK. Its primary purpose is to provide a secure, standardised, and efficient method for manufacturers to report safety-related information, enabling MHRA to monitor device performance and risks more effectively. Source: Manufacturer’s Online Reporting Environment (MORE)

2. Who should use MORE

MORE is intended for:

• Medical device manufacturers
• UK Responsible Persons acting on behalf of overseas manufacturers
• Organisations responsible for submitting vigilance data to MHRA

These users are required to use MORE when reporting serious incidents and safety-related actions involving medical devices placed on the UK market. Source: Manufacturer’s Online Reporting Environment (MORE)

3. Types of reports submitted via MORE

Through MORE, users can submit a range of post-market safety reports, including:

• Manufacturer Incident Reports (MIRs) for serious incidents
• Field Safety Corrective Actions (FSCAs), such as recalls or safety notices
• Follow-up reports and final reports linked to previously submitted incidents

The system ensures that reports are structured consistently and contain the information required under UK medical device legislation. Source: Manufacturer’s Online Reporting Environment (MORE)

4. Access and account management

To use MORE, organisations must first register for an account with MHRA. Account access is controlled to ensure data security and confidentiality. Once registered, users can manage submissions, track report status, and maintain records of communications with MHRA within the system. Source: Manufacturer’s Online Reporting Environment (MORE)

5. Role of MORE in vigilance compliance

MORE supports compliance with UK vigilance obligations by:

• Enabling timely reporting of serious incidents
• Facilitating structured communication between manufacturers and MHRA
• Improving data quality and traceability of safety reports

Use of MORE does not change the legal responsibilities of manufacturers but provides a practical tool to meet existing regulatory requirements more efficiently. Source: Manufacturer’s Online Reporting Environment (MORE)

6. Relationship with post-market surveillance systems

MORE forms part of the broader UK post-market surveillance and vigilance framework. Information submitted through the system contributes to MHRA’s ongoing assessment of device safety and may inform regulatory actions, safety communications, or further investigations where necessary. Source: Manufacturer’s Online Reporting Environment (MORE)

7. Practical considerations for manufacturers

Manufacturers are encouraged to:

• Establish internal procedures for identifying reportable incidents
• Ensure staff are trained in using MORE
• Maintain accurate records of all submissions and correspondence

Early and accurate use of MORE supports regulatory compliance and helps protect patient and user safety across the UK market. Source: Manufacturer’s Online Reporting Environment (MORE)