Europe issues new guidance document on medical device post market surveillance and vigilance.
The European Commission has issued a revised version of MEDDEV 2.12-1 which provides guidance to industry and Competent Authorities on how to meet the medical devices vigilance system requirements. Version 5 replaces version 4 which was released in 2001. The new MEDDEV is 56 pages long so we have attempted to summarize some of the key changes that may affect you.
MORE STRINGENT REPORTING TIMELINES
Revision 4 required reporting of Incidents and Near Incidents within 2, 10 or 30 days but national laws sometimes contradicted these parameters by indicating 2, 5, 10, 15 or 30 days. The new MEDDEV harmonizes timelines and states that you must report Incidents as follows:
- Serious public health threat: Immediately but no more than 2 days.
- Death or serious deterioration of health: Immediately but no more than 10 days.
- Other: Immediately but no more than 30 days.
Immediately means "without any delay that could not be justified." The Competent Authorities will not allow you to investigate for extended periods. If in doubt, report it because the Competent Authorities will be watching.
NEW DEFINITION OF INCIDENTS
The term Near Incident has been deleted. Now there are only Events and Incidents. All Incidents are considered Events but not all Events are Incidents! The new guidelines say that you must determine whether an Event is an Incident quickly and if it meets all of the following criteria it is considered an Incident:
- An event may have occurred.
- The manufacturer's device is considered to be a contributory cause of the Incident.
- The event led, or might have led, to the death of, or serious deterioration in health of, a patient, user or other person.
FIELD SAFETY CORRECTIVE ACTION (FSCA) and FIELD SAFETY NOTICES (FSN)
The FSCA is the action you take to reduce the risk of death or serious deterioration of health associated with the use of devices already on the market. Field Safety Notice (FSN) is the new term for "Recall Notice." If a FSCA is issued outside Europe but the product is also sold in Europe, a FSCA report should be sent to the Competent Authority in which your Authorized Representative is located. Annexes 3-5 standardize the Incident Reporting Form, European Field Safety Corrective Action Report and Field Safety Notice.
USER ERROR AND ABNORMAL USE
If user error led to a serious deterioration in health or death of a user, reporting is mandatory. However, if abnormal use caused the problem, this is not reportable under this version of the MEDDEV. See section 5.1.5.