The European Medical Devices Directive (93/42/EEC) states that medical device manufacturers are legally required to report adverse incidents and Field Safety Corrective Actions (FSCAs)to Competent Authorities. However, the "when, what and to whom" aspect of EU incident reporting often confuses regulatory professionals.
The European Commission’s Guidance document MEDDEV 2.12/1 offers manufacturers valuable information on terminology, timelines and other vigilance reporting requirements.
Companies that fail to correctly report incidents could face severe financial penalties or criminal sentences. 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 Competent Authorities in the member states where the device is being marketed.
A FSCA report must also be distributed in the member state where the manufacturer or Authorized Representative is located, if the manufacturer is located outside of the EEA. A Field Safety Notice (FSN) must also be distributed to consumers in these member states.
EU Medical Device Vigilance Reporting Process
Shown below 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 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 incident reporting.
- If we act as your European Authorized Representative, we can submit incident reports to Competent Authorities 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 ensure that final incident reports are completed on time.
- We have experience assisting hundreds of manufacturers with post market surveillance, CE Marking and other regulatory consulting services.
Please contact us for more information on our medical device vigilance reporting services for Europe.