Please be informed that as of May 26, 2021, the European Regulation (EU) 2017/745 on Medical Devices (MDR) came into force. The MDR introduces a major update of the regulatory framework in the European Union and brings several changes to the scope of investigations that must be submitted for approval, the submission processes for clinical investigations and their substantial modifications, submission dossier contents and safety reporting.
All definitions provided in this section are compliant with the definitions stated in the Medical Device Regulation 2017/745.
Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
- investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
- providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products shall also be deemed to be medical devices:
- devices for the control or support of conception;
- products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in MDR Article 1(4) and products listed in Annex XVI of the MDR.
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,…
Please note that when a medical device is in the development phase, for example a prototype, the prototype may be tested on subjects in order to validate certain parts of the medical device. Although the prototype may not fulfil its intended medical purpose yet, the product nevertheless already qualifies as a medical device, since that is the potential aim of the product.
Any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person’s professional qualifications which gives, under that person’s responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.
However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices.
A medical device manufactured or modified in-house by health institutions to address, on a non-industrial scale, the specific needs of target patient groups which cannot be met at the appropriate level of performance by an equivalent device available on the market. They must comply with the rules laid out in Article 5.5 of Regulation (EU) 2017/745.
CE-marking or CE marking conformity
Belgium.be: CE label (click here)
A marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in the Regulation and other applicable Union harmonisation legislation providing for its affixing.
Any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance (including clinical benefits) of a medical device.
All clinical investigations involving a medical device without CE-marking or which is used outside the scope of its CE-marking, an opinion from both the Ethics Committee (EC) and Belgian competent authority (FAMHP) is mandatory. Depending on the status of the investigational medical device, the submission procedure can be different.
Submission package for EC/FAMHP approval
Only for clinical investigations for which U(Z)Gent act as a sponsor. Before setting-up your submission package, we ask you to contact Lieselot Burggraeve (email@example.com, +32 9 332 09 07) or Hélène De Naeyer (firstname.lastname@example.org, +32 9 332 05 05) to arrange a meeting to discuss your trial.
- Cover letter (completed by HIRUZ CTU)
- List of documents submitted (completed by HIRUZ CTU)
- Application form MDR, including appendices (completed by HIRUZ CTU)
- Clinical Evaluation Plan (template)
- Clinical Investigation Plan (CIP, protocol) (template)
- Synopsis of Clinical Investigation Plan (separate document, English + local language) (template)
- Patient related documents
- Informed Consent Form(s) (ICF(s)) (template)
- Recruitment material, flyers, posters
- Diaries, questionnaires, interview topic list,…
- Description of the compensation for trial participants (template)
- Data/documentation of Investigational Medical Device (IMD):
- Investigator Brochure (IB): Investigator’s Brochure, contains the clinical and non-clinical information on the investigational device that is relevant for the investigation and available at the time of application (see MDR Annex XV, Chapter II, point 2). (template)
- Manufacturer’s Instructions for Use (local language)
- List of General Safety and Performance Requirements (template)
- Notified Body Certificates as applicable
- Example of Device Label for the study
- Other documents
- Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data (template)
- Data processing register (DMP online)
- (Draft) intersite agreements / proof of funding (application), as applicable
- Signed CV of all participating Principal Investigator(s)
- GCP-certificate of all participating Principal Investigator(s)
- Declaration of interest of all participating Principal Investigator(s) (template)
- Signed Suitability of sites (Written Statement) (template)
- Insurance certificate (provided by HIRUZ CTU)
- Preparation of your submission package (see above)
- Registration at HIRUZ CTU. Please email the draft submission package in word-version to email@example.com.
- 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 submission packages is submitted to HIRUZ CTU, the insurance class and the need for agreements will be evaluated.
- Submission to HIRUZ CTU. After HIRUZ CTU has received your final revised submission package, HIRUZ CTU will submit your dossier electronically.
- Remarks EC/FAMHP. Please answer the remarks of EC/FAMHP within the specified timelines.
- Approval and Site Initiation. Your trial can only start when a favorable opinion from EC/FAMHP has been received and as soon as all agreements are finalized (if applicable). In addition, 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/ISO14155, CIP, ICF procedure, Investigator Site File, safety follow-up,…). This initiation visit must take place before inclusion of the first patient at each site.
- First patient in. Please notify both HIRUZ CTU (firstname.lastname@example.org) when first patient is included.
- End of clinical investigation: Please notify HIRUZ CTU (email@example.com) when the last visit of last patient took place in Belgium as well as when last visit of last patient took place in all Member States (as applicable).
- Clinical Investigation report. At the end of your trial, please provide an Clinical Investigation report (template) to HIRUZ CTU (firstname.lastname@example.org)