DG Health and Consumers (SANCO)
Directorate B-Consumer Affairs
Unit B2- Health Technology and Cosmetics
MEDICAL DEVICES: Guidance document
MEDDEV 2.12-1 rev 8
ON A MEDICAL DEVICES VIGILANCE SYSTEM
The present guidelines are part of a set of guidelines relating to questions of application of
EC-Directives on MEDICAL DEVICEs. They are legally not binding. The guidelines have
been carefully drafted through a process of intensive consultation of the various interested
parties (competent authorities, Commission services, industries, other interested parties)
during which intermediate drafts were circulated and comments were taken up in the
document. Therefore, this document reflects positions taken by representatives of interested
parties in the MEDICAL DEVICEs sector.
Revision 8 of MEDDEV 2.12-1 explicitly includes IVF/ART devices within the scope of the
vigilance system and provides clarity in relation to devices that are not intended to act
directly on the individual. The revised guidance will be applicable as of July 2013.