Revision 7 of MEDDEV 2.12-1, the new European Medical Device Vigilance Guidelines, will replace the current version on June 15, 2012. It may lead you to update your vigilance and postmarketing procedures. The new revision incorporates Manufacturer's Trend Report and Periodic Summary Report forms. It encourages manufacturers and Competent Authorities (CAs) to use these alternative ways to report incidents and events.
Another change involves the addition of examples of reportable field safety corrective actions (FSCA), meaning that not all FSCAs are reportable. This applies not only to recalls for purely commercial reasons, but also FSCAs for technical reasons, when the risk of a serious deterioration in the state of health is remote.
When a manufacturer identifies a significant increase or trend of events/incidents through its postmarketing system that usually are not reportable, a trend report should be sent to the national CA where the manufacturer’s authorized representative has its registered place of business.
The manufacturer should define previous trigger levels to determine the reporting threshold. An initial trend report shall be sent describing the identified trend, the time period of the trend analysis, and the established trigger level with a preliminary analysis of the causes of the trend. When the manufacturer has completed the investigation, a final report should be sent indicating trend analysis results, the corrective and preventive actions that have been implemented, the time schedule for the actions and final comments. In the case of FSCAs, the appropriate reporting procedure shall be followed.
Periodic summary reporting
When a manufacturer reports a number of similar incidents affecting the same type of device, where the root cause is known or an FSCA has been implemented, he or she may request and obtain an agreement from an individual national CA to send a Periodic Summary Reporting form instead of declaring each adverse event. The manufacturer then shall inform the other concerned CAs of the agreement and its modalities and request its extension to them. The Periodic Summary Reporting form sent according to an agreed-upon frequency (from monthly to yearly) contains the number of incidents (new, cumulative, resolved, and in progress) without incident details.
Examples of reportable FSCAs
Revision 7 of the MEDDEV guidance introduces in section 10.1 of Annex 1, examples of FSCAs that the manufacturer should report.
Section 5.4.4 Field Safety Corrective Action of the guidance instructs the manufacturer to report to the national CA any technical or medical reasons leading to a systematic recall of devices. Those reasons can be any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the instructions for use “which might lead or might have led to the death of a patient or user or to a serious deterioration in his state of health.” The fact that the new vigilance guidance includes examples of FSCAs that the manufacturer should report means, conversely, if the likelihood of a serious deterioration in the state of health is remote, the FSCA is not reportable.
As for incident reporting, a formal reportability assessment based on a health hazard evaluation should be conducted and if the risk of a serious deterioration in state of health is remote, then it is not mandatory to report the FSCA to the appropriate EU CA. In case of doubt, it is preferable to report.
The examples of reportable FSCAs in the guidance always show a risk of serious deterioration in the state of health. For example:
The manufacturer of a pacemaker has identified a software bug in a pacemaker that has been placed on the market. The initial risk assessment identified the risk of a serious deterioration in state of health as being remote. Subsequent failure results and the new risk assessment carried out by the manufacturer indicate that the likelihood of the occurrence of a serious deterioration in state of health is not remote. The FSCA should be reported.
It may be advisable for a future revision of this MEDDEV to provide examples of nonreportable FSCAs.
Other minor changes
Additional examples of reportable incidents have been added. In section 4.5 EUDAMED, data concerning clinical investigations have been added. In the Manufacturer’s Incident Report form and Manufacturer’s Field Safety Corrective Action Report form, Turkey (TR) is now integrated in the overall country list, Bulgaria is abbreviated as BG instead of BU, and among the candidate countries, Croatia is abbreviated as HR instead of CR.
Revision 7 of the EU guidelines on a medical device vigilance system can be downloaded at http://ec.europa.eu/health/medical-devices/files/meddev/2_12_1_ol_en.pdf
René Clement is co-chairman of MediMark Europe, which serves as an authorized representative for U.S. manufacturers of medical devices and IVD products.