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Responsibilities for IVD
Manufacturers
An IVD manufacturer’s challenges
are unique because in vitro devices do not generally come into contact with
patients or users and incidents caused by in vitro device involvement can be
difficult to prove. However, the MEDDEV-5 guidelines help to preclude any
non-disposition to report by stating explicitly that there should “be a
predisposition to report.”In addition to reporting possible IVD incidents, IVD
manufacturers also have the responsibility to review user instructions and
labels.
Responsibilities for Notified
Bodies
Notified bodies act as assessors
of conformance and are thus an essential part of compliance and finalized
assessment results. According to the MEDDEV-5, “Notified Bodies do not play a
key operational role in the Medical Device Vigilance System” but the “overall
performance of the Medical Device Vigilance System is supported by the notified
body activity in the following areas like Assessment of vigilance procedures
,Audit of the implementation of the vigilance procedures, and link with other
systems e.g. Corrective and Preventive Action (CAPA), FSCA , Assessment of the
impact of vigilance issues on the certification granted and Liaise with the
National Competent Authority if required, e.g. specific investigations/audits
based on a request of the National Competent Authority.”
Users’ Responsibilities
Since the users of medical
devices are often the first to observe incidents related to device error or the
first to observe inappropriate usage methods, users are absolutely indelible to
the healthy ebb and flow of the European Medical Device Vigilance System. For
this reason, the MEDDEV-5 has specified the following responsibilities for
users:
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Report medical device related incidents to the
appropriate manufacturer, or
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Report medical device related incidents to the
appropriate NCA (National Competent Authority);
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Participate in the appropriate procedures that are
specified by corrective action assignments.
The Responsibilities of
National Competent Authorities
The responsibilities of National
Competent Authorities written within the MEDDEV-5 extend past administration and
into the realms and roles of liaison work and expert communication. These
responsibilities include the following:
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Send report receipts to manufacturers;
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Evaluate (with the help of the manufacturer if
possible and/or practicable) reports;
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Provide advice when necessary;
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Provide intervention when necessary;
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Monitor the investigations of incidents;
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Supplement, if necessary, an incident investigation;
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Help prevent additional similar incidents by
providing preventative information;
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Help educate the purchasers of medical devices in
regards to the MEDDEV-5 guidelines;
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Help educate users of medical devices in regards to
the MEDDEV-5 guidelines;
-
Encourage incident reporting.
Regardless of whether or not a
company plans on entering the European medical device industry or is already a
participant, the recent MEDDEV-5 guidelines are valuable information for
best-practice success.
(
http://www.mastercontrol.com/newsletter/medical_device/
european_medical_device_vigilance_system_guidelines_0308.html ).
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