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The European Medical Device Vigilance
SystemArticle
10 of the MDD requires Member States to take the necessary steps to ensure that any
information brought to their knowledge about
- any malfunction 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 might lead or
have led to the death of a patient or user or to a serious deterioration in his 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,
Commission, Notified Bodies, and users are regulated in the draft document
MEDDEV
2.12/1: 'Guidelines on a medical device vigilance system'
In contrast to the medical device reporting (MDR) system of the United States only serious
and potentially serious problems with devices have to be reported in Europe. Similar to
the MDR the European vigilance guideline asks for global reporting of incidents no matter
in which country they happen.
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 II, IV, V, VI, and VII of the MDD.
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 with the parties concerned as soon as possible. Thus the safeguard
clause in Article 8 of the MDD gives Member States the right to immediately intervene even
in the case of correctly CE marked devices, if there is an acute danger for the health of
patients, users or third persons.
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