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Abstract

These guidelines describe the European system for the notification and evaluation of INCIDENTs and FIELD SAFETY CORRECTIVE ACTIONS (FSCA) involving MEDICAL DEVICEs, known as the Medical Device Vigilance System.

The principal purpose of the Medical Device Vigilance System is to improve the protection of health and safety of patients, USERs and others by reducing the likelihood of reoccurrence of the INCIDENT elsewhere. This is to be achieved by the evaluation of reported INCIDENTs and, where appropriate, dissemination of information, which could be used to prevent such repetitions, or to alleviate the consequences of such INCIDENTs.

Notes

These guidelines on the Medical Device Vigilance System are part of a set of Medical Device Guidelines that promote a common approach by MANUFACTURERs and Notified Bodies involved in the conformity assessment procedures according to the relevant annexes of the directives, and by the National Competent Authorities charged with safeguarding public health.

They have been carefully drafted through a process of consultation with various interested parties during which intermediate drafts were circulated and comments were taken up in the documents. Therefore, it reflects positions taken in particular by representatives of National Competent Authorities and Commission Services, Notified Bodies, industry and other interested parties in the MEDICAL DEVICEs sector.

The guidelines are regularly updated accordingly with regulatory developments. The latest version of the guidelines should always be used. This revision of these guidelines has:

carefully considered and transposed into the European context the Global Harmonisation Task Force (GHTF)1 international regulatory guidance documents on vigilance and post market surveillance;

addressed the introduction of European medical device database EUDAMED;

amended the document in light of experience with previous clauses.

These guidelines are not legally binding. It is recognised that under given circumstances, for example, as a result of scientific developments, an alternative approach may be possible or appropriate to comply with the legal requirements.

Nevertheless, due to the participation of the aforementioned interested parties and of experts from National Competent Authorities, it is anticipated that the guidelines will be followed within the Member States and, therefore, work towards uniform application of relevant directive provisions and common practices within Member States.

However, only the text of the Directives is authentic in law. On certain issues not addressed in the Directives, national legislation may be different from these guidelines.

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