Global Medical Device Reporting and Vigilance

International Medical Device Reporting

Medical Device Reporting and Vigilance in the EU and Globally 

Timely and transparent reporting of medical device incidents is critical to protecting public health and ensuring continued confidence in healthcare technologies. While the United States relies on FDA’s Medical Device Reporting (MDR) requirements, other regions have developed their own frameworks to identify, assess, and act on adverse events involving medical devices. 

In the European Union, the Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) establish a comprehensive vigilance system that requires manufacturers, authorized representatives, and importers to report serious incidents, field safety corrective actions, and trends indicating a potential risk. These reports are centralized through the EUDAMED database, fostering coordinated oversight across member states. 

Globally, regulatory authorities—including Health Canada, the UK’s MHRA, Australia’s TGA, and Japan’s PMDA—have adopted diverse yet converging approaches to post-market surveillance. Many are aligning with the guidelines issued by the International Medical Device Regulators Forum (IMDRF), which promotes harmonized principles for vigilance and adverse event reporting. 

This page offers an overview of key reporting requirements, timelines, and systems used across major regulatory jurisdictions, helping stakeholders understand their obligations and best practices in maintaining device safety and compliance worldwide. 

European Union (EU) – Vigilance under the MDR (EU) 2017/745 

Key Concepts

“Vigilance” refers to reporting and investigating serious incidents and field safety corrective actions (FSCAs) related to devices already on the market. 

All vigilance activities must be reported to Eudamed, the European database on medical devices. 

Manufacturer Obligations

Serious Incident Reporting (Article 87) 

• Timeline: 

• Death or serious public health threat: report within 2 days 

• Serious deterioration in health: within 10 days 

• Incidents must be reported even if caused by use error or interactions with other devices. 

Field Safety Corrective Action (FSCA) 

• Actions taken to reduce the risk of death or serious health deterioration (e.g., recalls, safety notifications). 

• Must be reported in advance of implementation, if possible. 

• Accompanied by a Field Safety Notice (FSN) for users/customers. 

Trend reporting (Article 88) 

• If non-serious incidents or expected adverse events are occurring more frequently, manufacturers must report the trend. 

Vigilance file & postmarket surveillance (PMS) 

• Maintain a PMS system per Annex III of the MDR. 

• Data should feed into Periodic Safety Update Reports (PSURs) and PMCF studies. 

Other Global Geographical Jurisdictions 

The UK’s MHRA: Vigilance and Post-Market Surveillance 

Since the United Kingdom’s exit from the European Union, the Medicines and Healthcare products Regulatory Agency (MHRA) has established its own independent regulatory framework for medical devices, while maintaining many of the core principles of EU vigilance systems. 

Under the current UK Medical Devices Regulations 2002 (as amended), manufacturers, UK Responsible Persons, and healthcare providers are required to report adverse incidents involving medical devices that occur in Great Britain (England, Scotland, and Wales). A separate system remains in place for Northern Ireland, which continues to align more closely with EU MDR requirements under the Northern Ireland Protocol. 

Key MHRA Vigilance Requirements

Serious incidents involving medical devices must be reported to the MHRA as soon as possible, and within specific timelines depending on the severity of the risk: 

• 2 days for incidents that led to death or serious deterioration in health. 

• 10 days for incidents that might have caused serious harm if not addressed. 

• 15 days for all other reportable events. 

Field Safety Corrective Actions (FSCAs) – such as device recalls, software patches, or updated instructions—must also be reported along with a Field Safety Notice (FSN) to inform users of the issue and the corrective steps. 

Reporting is completed through the MHRA’s MORE portal (Manufacturer Online Reporting Environment), a secure system for submitting incident reports, FSCAs, and updates. 

UK Responsible Persons (UKRPs) – required for foreign manufacturers selling into the UK – are responsible for ensuring that incidents and corrective actions are reported appropriately if the manufacturer is not UK-based. 

FDA Medical Device Reporting

Reporting to Other Regulatory Entities 

European Union 

Competent Authorities (CAs) 

• Serious incidents and FSCAs must be reported to the Competent Authority of the Member State where the incident occurred or where the FSCA is being carried out. 

• In parallel, they must be uploaded to Eudamed, which is accessible to CAs across the EU. 

• If Eudamed is not fully functional, manufacturers must directly notify each relevant national CA (e.g., BfArM in Germany, MHRA in the UK pre-Brexit, AEMPS in Spain, etc.). 

Notified Bodies (NBs) 

• Notified Bodies are generally not directly involved in incident reporting. 

• However, they must be informed if an FSCA affects the conformity assessment or if the incident indicates a failure in the device’s design or compliance. 

• NBs may trigger a special audit or request a reassessment. 

United Kingdom (UK) 

Role of UK Approved Bodies 

• Conduct conformity assessments for medical devices that do not qualify for self-declaration (typically Class IIa, IIb, and III, and active implantables). 

• Review technical documentation, clinical evaluations, and quality management systems (QMS). 

• Issue UKCA Certificates (like CE certificates in the EU) for medical devices under the UK Medical Devices Regulations 2002, as amended. 

UK Responsible Person (UKRP) 

For non-UK manufacturers, there is no concept of a Notified Body acting as a market intermediary — instead, they must appoint a UK Responsible Person, who: 

• Acts as the liaison with the MHRA, 

• Holds technical documentation, 

• Ensures compliance, and 

• Is responsible for post-market surveillance and incident reporting. 

Canada (Health Canada) 

• There is no separate “competent authority” system; Health Canada itself serves as the central authority. 

• No requirement to inform external bodies like third-party auditors unless part of ISO certification. 

Australia Therapeutic Goods Administration (TGA) 

• The TGA is both the competent authority and the enforcement body. 

• Sponsors and manufacturers must notify TGA; there is no separate NB or external CA to contact. 

• However, for devices also regulated under ISO 13485, your certification body may request incident data during audits. 

Japan (PMDA / MHLW) 

• Reports go to the PMDA, which forwards to MHLW if policy action is needed. 

• Marketing Authorization Holders (MAHs) must also notify third-party conformity assessment bodies (RCB) if they were involved in product certification. 

• If the event affects product conformity, re-certification may be required. 

China (NMPA) 

• Incidents must be reported to: 

• NMPA at the national level 

• Provincial Medical Products Administration (PMPA) where the incident occurred 

• No Notified Body system, but local agents or license holders are legally responsible for submission. 

Brazil (ANVISA) 

• Reports are submitted to ANVISA via the Notivisa portal. 

• No separate CA system. 

• The local legal representative (often the importer) shares liability and may be required to co-sign reports. 

General Rules for Involving Notified Bodies 

Practical Tip: 

Even if not mandatory, keeping NBs informed proactively shows good faith and improves audit preparedness. Regulators may also coordinate with your NB after receiving your FSCA reports.