Any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be
used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
- investigation, replacement or modification of the anatomy or of a physiological process,
- control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its
function by such means (under the scope of the Medical Device Directive 93/42/EEC).
In deciding whether a product falls under the MDD, particular account shall be taken of the principal mode of action of the product. Typically, the medical device function is achieved by physical means (including mechanical action, physical barrier, replacement of or support to organs or body functions …). The principal intended action of a medical device may be deduced from the scientific data regarding mechanism of action and the manufacturer’s labelling and claims.
Examples: bandages, sutures, wheelchair, hospital bed, dentist mouth mirror, dental filling materials, heart rate monitor, blood pressure monitor, ECG device, EEG device, scalpel, needles, hearing aid, glasses and lenses, stents, blood bags, condoms, implants, catheters, defibrillator, eHealth app,…
A custom-made device is defined as any device manufactured specifically in accordance with a written prescription of a registered medical practitioner, or other person authorized to write such a prescription by virtue of his professional qualification, which gives under his responsibility, specific characteristics as to its design, and is intended for the sole use of a particular patient. This does not include a mass-produced product which comprises a medical device and medicinal product forming a single integral product which needs to be adapted to meet the specific requirements of the medical practitioner or professional user (KB March 18, 1999).
belgium.be: CE label (click here)
When a device is CE-marked, it indicates that the product meets the European requirements for safety, health and protection of the environment. It complies with EU regulations and can therefore be sold freely throughout the European Economic Area. The CE-marking is the responsibility of the device manufacturer. Exception: for custom-made device no CE-marking is needed.
For clinical trials with medical devices without CE-marking or which are used outside the scope of their CE-marking, approval from both the EC and FAMHP is mandatory.
Submission package for EC and FAMHP approval
- Cover letter for the EC, signed by the PI (template: click here)
- Cover letter for the FAMHP, signed by the coordinating investigator
- EC application form, document A, signed (most recent version: click here)
- List of essential requirements (listed by the FAMHP, click here)
- FAMHP Application Form for medical device trials (click here) (if Ghent University (Hospital) does not act as the sponsor of the trial: to be provided by the sponsor)
- Protocol / Clinical Investigation Plan (CIP) (template: click here)
- Informed Consent Form(s) (template: click here)
- Investigator’s Brochure
- Instructions for use
- Device label
- CE-certificate (if applicable)
- All documents provided to the subjects (e.g. recruitment material, flyers, posters, diaries, questionnaires, interview topic list…)
- Data processing register (Ghent University Hospital studies: click here, Ghent University studies: click here)
- Agreements (if applicable – a draft version is sufficient)
- CV and GCP certificate of the PI at Ghent University (Hospital)
- CVs and GCP certificates of all local PIs (if applicable – in case of a multicentric study)
- Insurance certificate (only if Ghent University (Hospital) does not act as the sponsor of the study; otherwise provided by HIRUZ CTU)
- Preparation of your submission package (see above)
- Registration at HIRUZ CTU. Please email the completed submission package in word-version to firstname.lastname@example.org.
- Revision by HIRUZ CTU. HIRUZ CTU will revise all documents and will provide you feedback by email together with an internal reference number (BC-number). As soon as your trial is submitted to HIRUZ CTU, the need for an insurance and Clinical Trial Agreement or another type of scientific collaboration agreement will be evaluated.
- Submission to HIRUZ CTU. After HIRUZ CTU has received your final revised submission package, HIRUZ CTU will submit your dossier electronically to the Ethics Committee of Ghent University Hospital and Ghent University and FAMPH.
- Allocation of an EC project number. The Ethics Committee of Ghent University Hospital and Ghent University will send you the EC project number by email once your submission package is considered complete.
- Questions or remarks? The Ethics Committee of Ghent University Hospital and Ghent University will contact you directly in case of any questions or remarks. Remarks of FAMHP will be sent to you via HIRUZ CTU.
- Approval and Site Initiation. Your trial can only start when a favorable opinion from the central EC and FAMHP has been received and as soon as all agreements are finalized (if applicable). In addition, in case Ghent University (Hospital) is sponsor, HIRUZ CTU will set-up a trial initiation visit at each participating site to discuss the practical aspects of the trial and provide the necessary training (ICH-GCP, protocol, ICF procedure, Investigator Site File, safety follow-up,…). This initiation visit must take place before inclusion of the first patient at each site.
Please notify both HIRUZ CTU (email@example.com) and the Ethics Committee of Ghent University Hospital and Ghent University (firstname.lastname@example.org) when your study starts (first study specific procedures performed/first ICF signed).
- Annual progress report. Please provide an annual progress report yearly to both HIRUZ CTU (email@example.com) and the Ethics Committee of Ghent University Hospital and Ghent University (firstname.lastname@example.org).
- End of trial report. At the end of your trial, please provide an end of trial report including date of last trial specific procedure performed, final number of participants and events of special interest to both HIRUZ CTU (email@example.com) and the Ethics Committee of Ghent University Hospital and Ghent University (firstname.lastname@example.org).
Before setting-up your trial, you can always contact us directly via Hélène De Naeyer (email@example.com, +32 9 332 05 05) or Lieselot Burggraeve (firstname.lastname@example.org, +32 9 332 09 07) to ask questions or to arrange a meeting to discuss your trial.