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.
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:
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.
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:
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.
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.