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The European Medical Device Vigilance
System
Article 11 of the IVDD
requires Member States, in relation to in-vitro diagnostic devices that are CE-marked, to
take the necessary steps to ensure that any information brought to their knowledge about
any malfunction, failure
or deterioration in the characteristics and/or performance of a device, as well as any
inadequacy in the labeling or the instructions for use which, directly or indirectly,
might lead to or have led to the death of a patient, or u ser or of other person or to a
serious deterioration in their state of health,
any technical or medical
reason in relation to the characteristics or performance of a device for the reasons
referred to above, leading to a systematic recall of devices of the same type by the
manufacturer.
is recorded and evaluated
centrally. Details of the medical device vigilance system and the necessary activities of
the manufacturers, Competent Authorities, EC Commission, Notified Bodies, and users are
regulated in the draft document
MEDDEV 2.12/1 'Guidelines
on a medical device vigilance system'. (PDF, 351)
The obligation of medical
device manufacturers to institute and keep up to date a systematic procedure to review
experience gained from devices in the post-production phase and to implement appropriate
means to apply any necessary corrective action is regulated in the conformity assessment
procedures in the Annexes III, IV, VI, and VII. The proper establishment of this
post-marketing surveillance (PMS) system by the manufacturer is subject to the inspections
by the Notified Body.
Where a Member State
ascertains that medical devices, when correctly installed, maintained and used for their
intended purpose, may compromise the health and/or safety of patients, users or, where
applicable, other persons, it shall take all appropriate interim measures to withdraw such
devices from the market or prohibit or restrict their being placed on the market or put
into service. The Member State shall immediately inform the Commission of any such
measures, indicating the reasons for its decision. The Commission shall enter into
consultation, as far is possible, with the parties concerned. When the measures of the
Member State are justified the Commission will remit the necessary measures for the EC.
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