medical devices
Consultation procedure for medical devices
Medical devices may contain a substance that is an integral part of
the medical device but that is a medicinal product when used
separately. When assessing medical devices of this kind, Notified
Bodies need to seek advice from a competent authority with regard
to the substance (via what is known as the consultation
procedure).
The Notified Body takes the final decisions on the approval for
(certification of) medical devices and therefore takes the final
responsability. The advice by the consulted medicines agency,
offered during the consultation procedure, has no binding
effect.
Click here for procedure and dossier
requirements
The MEB has regularly been consulted by a variety of Notified
Bodies since 1995. The substances in question are assessed by the
employees who also assess the medicinal product dossiers in the
corresponding Pharmacotherapeutic group.
Consultancy (prior to the Consultation
Procedure)
The MEB can now also be asked for advice in relation to
consultation procedures before submitting a dossier. As with
requests for advice on medicinal products, this advice can relate
to scientific or regulatory aspects or take the form of a
pre-submission meeting. Scientific Advice and Regulatory Advice can
be sought by the Notified Body as well as by the manufacturer of
the medical device. In case of advice sought by the Notified Body,
the Notified Body can invite the manufacturer of the medical device
in question to accompany it to the advisory meeting. In case the
advice is sought by the manufacturer, then the manufacturer is
strongly advised to inform the (future) Notified Body about it.
Pre-submission meetings can be sought by the Notified Body only, as
the Consultation Procedure which will follow shortly, is a
procedure by Notified Body and MEB.
Negative Opinion (in the Consultation Procedure
itself)
If any objections remain during the consultation procedure, and the
MEB therefore comes to the view (usually after two assessment
rounds) that a negative opinion will probably result, then as with
applications for medicinal products it offers to arrange a hearing
so that views can be expressed. This gives the Notified Body the
opportunity to explain the situation. If the Notified Body wishes,
it can invite the manufacturer of the medical device in question to
accompany it.
Notification of adverse events and
calamities
In contrast to medicinal products, the MEB
is not the Competent Authority in the Netherlands for medical
devices. This includes medical devices that contain pharmaceuticals
to assist their functioning, about which the MEB can make
recommendations to a Notified Body via a consultation procedure.
The Competent Authority for all medical devices in the Netherlands
is the Dutch Health Care Inspectorate
(IGZ). Any adverse events and calamities must be reported to
the IGZ (in addition to the Notified Body who issued the
certificate). The MEB wishes to receive a copy however.
More information
