Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
MedEnvoy Global
The Hague, Netherlands, London, United Kingdom, United States, Switzerland, Australia
A global regulatory compliance partner specializing in in-country representation (EC Rep, UKRP, CH Rep, US Agent) and independent importer services for medical device and IVD manufacturers. We help companies navigate complex regulations in Europe, the UK, Switzerland, and the US while maintaining supply chain flexibility.
KoBridge Co Ltd
Seoul, Korea, Lausanne, Switzerland
We offer fast, effective, and flexible solutions for medical device manufacturers needing to navigate the increasing complexity of global regulations. Their core competencies cover CE Marking, FDA 510(k)/PMA, MDSAP, and especially Korea MFDS registration and KGMP compliance. They handle active, non-active, combination, and animal-origin devices, providing services from strategic planning and dossier preparation to quality system implementation (ISO 13485) and audits.
IMed Consultancy Ltd
United Kingdom, Ireland
Helping medical device and in-vitro diagnostic companies with CE marking, quality management systems, auditing, and global registrations.
September 16, 2025
Approximately 5 minutes
Digital Safety Reporting for Medical Device Manufacturers in the UK
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)
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