A manufacturer, or his legal representative, must notify the Research and Development (human use) department of the FAMHP and a fully recognized ethics committee of any clinical investigation in humans with a medical device or an active implantable medical device (AIMD), with or without CE marking, of which the purpose is to assess the performance and/or safety of the device in regards to its commercialization.
The manufacturer must notify the Research and Development (human use) department of the FAMHP of any clinical investigation of which the aim is:
- collecting clinical data about a medical device or an AIMD without a CE marking,
- collecting clinical data on a medical device or a CE marked AIMD that is used outside of the CE marking or outside of the intended use provided in the instructions for use of the medical device under investigation.
The manufacturer concerned must submit the notification file electronically via the Common European Submission Platform (CESP) and in accordance with the established procedure to the Research and Development (human use) department of the FAMHP. The file must contain the following elements, if applicable:
- Cover letter
- Notification form
- Clinical Investigational Plan (CIP) or protocol according to ISO-norm 14155 for clinical investigations
- Investigator’s Brochure (IB): the investigation file containing the clinical and non-clinical information for the medical device under investigation (see details in Annex B of ISO standard 14155),
- Manufacturer’s instructions for use
- Example of labels
- List of essential requirements
- Proof of insurance according to article 29 of the Law of 7 May 2004 relating to experiments on the human person
- Informed consent forms
- Approval of EC or proof of application to EC
- Decisions from other competent authorities
- CV(s) of principle investigator(s)
- Decisions from other countrie
The legal deadlines for the handling of the dossier depend on the medical device class.
- For devices of class III, active implantable medical devices, devices of class IIa or IIb intended for long-term use, the FAMHP must validate the file within twenty days of receipt. An acknowledgement of receipt (AoR) will be sent to the applicant on the date of validation. From that moment on, the FAMHP has sixty days to issue an opinion on the file.
- For other medical devices, the clinical investigation may commence at the time of notification, provided that the file submitted is complete and that a fully recognized ethics committee has issued a favourable opinion on the clinical investigation.
The FAMHP recommends submitting the file to the ethics committee and the FAMHP at the same time so that each file can already be evaluated. If the clinical investigation has already started and the FAMHP has important comments, the investigation will be suspended as stipulated in Article 9, § 7, of the Royal Decree of 18 March 1999. This decision and the reasons for it will be communicated to the other Member States , as defined in Belgian and European legislation.
A fee is payable for the notification of clinical investigations and after the submission of a clinical investigation an invoice will be sent to the applicant. The amount is stated on the FAMHP website. Attention, this is a new payment method where the invoice replaces the advanced payment.