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 given by the consulted competent authority, offered during the consultation procedure, has no binding effect.
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.
Possibilities for advice (preceding 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 (at the close of the consultation procedure)
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 Health and Youth Care Inspectorate (IGJ). Any adverse events and calamities must be reported to the IGJ (in addition to the Notified Body who issued the certificate). Only in case of a medical device with an added pharmaceutical substance, the MEB wishes to receive a copy. You can send this via the contact form, or by postal mail to the address:
Medicines Evaluation Board
PO Box 8275
3503 RG Utrecht