EU/EC MEDDEV 2.12-1 PDF

These guidelines describe the requirements of the Medical Device Vigilance System as it applies to or involves:

• MANUFACTURERs²

• National Competent Authorities (NCA)

• the European Commission

• Notified Bodies

• USERs and others concerned with the continuing safety of MEDICAL DEVICEs

These guidelines cover the actions to be taken once the MANUFACTURER or National Competent Authority receives information concerning an INCIDENT involving a MEDICAL DEVICE. Information on INCIDENTs which should be reported under the Medical Device Vigilance System may come to the attention of MANUFACTURERs via the systematic procedure to review experience gained from devices in the post-production phase, or by other means (see annexes II, IV, V, VI, VII of MDD and annexes III, IV, VI and VII of IVDD). The term "post-marketing surveillance" as referred to in Annexes 2, 4, 5 in AIMD has the same meaning as the aforementioned "systematic procedure".

These guidelines cover Article 8 (AIMD), Article 10 (MDD) and Article 11 (IVDD) outlining the obligations of Member States upon the receipt of INCIDENT reports, from MANUFACTURERs or other sources, concerning any MEDICAL DEVICE. They also include guidance to National Competent Authorities about the issue and receipt of information from National Competent Authorities outside Europe who are involved in the GHTF National Competent Authority Report (NCAR) exchange programme.

These guidelines are relevant to INCIDENTs occurring within the Member States of the European Economic Area (EEA) and Switzerland with regard to:

• a) devices which carry the CE-mark

• b) devices that do not carry the CE-mark but fall under the directives scope (e.g. custom made devices)

• c) devices that do not carry the CE mark because they were placed on the market before the entry into force of the medical devices directives.

• d) devices that do not carry the CE-mark but where such INCIDENTs lead to CORRECTIVE ACTION(s) relevant to the devices mentioned in a), b) and c).

These guidelines cover FIELD SAFETY CORRECTIVE ACTION relevant to CE-marked devices which are offered for sale or are in use within the EEA and Switzerland.

These guidelines make no recommendations on the structure of the systems by which MANUFACTURERs gather information concerning the use of devices in the post-production phase, of which the Medical Device Vigilance System is an integral part. Such recommendations are outside the scope of this document.

² including their Authorised Representatives and persons responsible for placing on the market, see section 4 on definitions.