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?
What is medical device vigilance and adverse event reporting?
The vigilance requirements in the Medical Device Regulation (MDR) No. 2017/745 (for medical devices or active implantable medical devices) and the In Vitro Diagnostic Device Regulation (IVDR) No. 2017/746 (for IVD devices) include notification and evaluation of “Incidents” and “Field Safety Corrective Actions” (FSCAs) involving medical devices. 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. Under the MDD/AIMDD and IVDD, MEDDEV 2.12/1 was issued to provide guidance on the vigilance reporting requirements. 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 or serious injury or may lead to death or serious deterioration in the 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.
The MDR and IVDR further address specific timelines for FSCA reports. The reporting timelines are as follows:
- Serious public health threat – immediately and not later than two days after the manufacturer becomes aware of the threat.
- Death or an unanticipated serious deterioration in a person’s state of health – immediately but not later than 10 days after the manufacturer becomes aware of the incident.
- Serious incident – immediately but not later than 15 days after the manufacturer becomes aware of the incident.
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 ensure 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 complimentary white paper, "Medical Device Vigilance Reporting in Europe," for an overview of event types that must be reported.
In addition to MEDDEV 2.12/1, the European Commission also published Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8, as well as several device-specific vigilance guidance documents (DSVGs) for specific high-risk device categories. The MDR extracts much of the requirements of the MEDDEV, with certain differences.
Who should receive an FSCA report?
The manufacturer or AR must notify the Competent Authorities (CA) of all affected countries, as well as the national CA where it is located, for any FSCA conducted in the EU. A recommended format is provided in Annex 4 of the MEDDEV, which is also available on the European Commission’s website.
FSCAs must also be notified to customers via a Field Safety Notice (FSN). The manufacturer must allow a minimum of 48 hours for receipt of comment on the FSN from the CA unless the nature of the FSCA dictates a shorter timescale.
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