European Medical Device Vigilance System Guidelines

The European Medical Device Vigilance System Guidelines version #5 provides clear guidelines for application with lawful directives (AIMD-Article 8, MDD-Article 10, IVDD-Article 11), explains the salient purposes of the system itself and describes the respective responsibilities of manufacturers, IVD manufacturers, medical device users, and National Competent Authorities (who represent the various units comprised within the European Economic Area or the EEA). The article focuses on the European Medical Device Vigilance System responsibilities.

The medical device industry, like most industries, is feeling the attractive pull of globalization. After all, global connections provide more business and combine innovative powers, two essential elements that are indispensable in successful med-device environments. Nevertheless, the beckoning call of global success isn’t always easy to follow. For many medical device companies (small, medium and large) new and uncharted regulatory requirements appear as major roadblocks to global expansion. Companies interested in venturing into Europe, however, will find that European guidelines (at least those specific to med-device regulations) are well-defined and often correspond in great measure with those regulations published by major regulatory bodies in the U.S.

For instance, the European Medical Device Vigilance System Guidelines version #5 (i.e. MEDDEV-5) provides clear guidelines for application with lawful directives (AIMD-Article 8, MDD-Article 10, IVDD-Article 11), explains the salient purposes of the system itself and describes the respective responsibilities of manufacturers, IVD manufacturers, medical device users, and National Competent Authorities (who represent the various units comprised within the European Economic Area or the EEA).

Like those guidelines within the United States, the MEDDEV-5 guidelines have the primary purpose of “the protection of health and safety of patients, users and others by reducing the likelihood of reoccurrence of the incident elsewhere.”. The additional purposes are to conform with many of the principles and textual guidelines promoted by the Global Harmonization Task Force (GHTF); to introduce the database EUDAMED and to improve upon past revisions of the MEDDEV guidelines.

The main purposes of the MEDDEV-5 are accomplished via the European Medical Device Vigilance System which comprises system responsibilities for the following groups:

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