Advice and consultation options before a consultation procedure

In the case of consultation procedures it is possible to ask the MEB to advise before submitting the dossier. As is the case with applications for medicinal products this relates to options for scientific or regulatory advice.

Scientific or regulatory advice

Scientific and regulatory advice can be requested both by the notified body and by the manufacturer of the medical device. If scientific (or regulatory) advice is desired, this will normally be requested at an earlier stage, as is the case with medicinal product applications. If the advice is requested by the notified body, the latter can invite the manufacturer of the medical device in question to accompany it to the advisory meeting. If the advice is requested by the manufacturer, the MEB strongly recommends that the manufacturer informs the (future) notified body about the meeting.

Pre-submission meeting

Pre-submission meetings can only be requested by the notified body because it is the notified body and not the manufacturer who submits the application for the consultation procedure to the MEB and communicates on it. The manufacturer of the medical device in question can attend the pre-submission meeting, but cannot request one. If a pre-submission meeting is desired, the MEB would like to receive a written announcement for a pre-submission meeting, preferably 1-2 months before the dossier is submitted