Medical Device Vigilance and Incident Reporting in Europe
ANSWERED ON THIS PAGE:
- When are vigilance reports for medical devices required in Europe?
- What is the EU medical device incident reporting process?
- How will Europe's new Medical Device Regulations affect vigilance requirements?
The European Medical Devices Directive (93/42/EEC) and In-Vitro Diagnostic Devices Directive (98/79/EC) state that medical device manufacturers are legally required to report adverse incidents and Field Safety Corrective Actions (FSCAs) to EU Competent Authorities. However, the "when, what, and to whom" aspect of EU incident reporting often confuses regulatory professionals.
Companies that fail to correctly report incidents could face severe consequences. Ignorance is not an acceptable excuse for not reporting incidents so RA professionals need to be proactive.
When are EU vigilance reports required?
The term "vigilance report" encompasses Incident Reports and Field Safety Corrective Action (FSCA) reports. According to MEDDEV 2.12/1, an incident report must be filed if a device malfunction, deterioration in device performance, inadequate instructions, or inadequate labeling results in death, serious injury, or may lead to death or serious deterioration in state of health if it were to recur. The incident must be reported to the Competent Authority (CA) of the member state where the incident occurred.
If a manufacturer takes an action to reduce the risk of death or serious deterioration in health, such as a recall, a Field Safety Corrective Action (FSCA) report must be distributed to CAs in the member states where the device is being marketed as well as the CA where the manufacturer or their AR is located.
Europe's new Medical Device Regulation (MDR) addresses specific timelines for FSCA reports. Download our free, in-depth white paper for details about MDR changes related to vigilance reporting: Understanding Europe's New Medical Device Regulation.
EU medical device adverse incident and FSCA reporting process
These are the basic steps to reporting an incident in Europe:
- Reference MEDDEV 2.12/1 to determine the correct reporting timeline, which will depend on the severity of the incident.
- Inform appropriate Competent Authorities that an incident has occurred.
- Respond to questions from Competent Authorities regarding devices involved, time on the market and design changes.
- Determine if a Field Safety Corrective Action (FSCA) and Field Safety Notice (FSN) are necessary and report to appropriate Competent Authorities.
- Submit a Final Incident or FSCA Report to Competent Authorities.
- Add vigilance reports, along with any correspondence with Competent Authorities to your ISO 13485 or other quality system records.
- Inform your Notified Body of any incidents or FSCAs unless your device is Class 1 self-certified.
Why choose Emergo to assist with European vigilance and incident reporting?
Emergo represents more than 1,000 medical device and IVD companies as an official EU Authorized Representative so our team is constantly involved in helping companies with vigilance reporting.
- If we act as your European Authorized Representative, we can submit incident reports to CAs on your behalf.
- Our in-depth knowledge of the European medical device market ensures that your vigilance procedures will always be up-to-date.
- Our experienced consultants can help determine when incidents are reportable and that final incident reports are completed on time.
We have experience assisting hundreds of manufacturers with post-market surveillance, CE Marking, ISO 13485:2016 certification, and other regulatory consulting services.
How can we learn more about vigilance reporting requirements in Europe?
The European Commission's Guidance document MEDDEV 2.12/1 offers manufacturers valuable information on terminology, timelines and other vigilance reporting requirements. Download our free white paper, Medical Device Vigilance Reporting in Europe, for an overview of event types that must be reported.
Who should receive an FSCA report?
If the manufacturer is located outside of the EEA, an FSCA report must be distributed in the member state where the manufacturer or Authorized Representative is located, in addition to the Competent Authorities in the member states where the device is marketed. A Field Safety Notice (FSN) must also be distributed to consumers in these member states.