Only for clinical investigations for which U(Z)Gent act as a sponsor.

Before setting-up your submission package, we ask you to contact the medical device focus team 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
  • Clinical Investigation Plan (CIP, protocol)
  • Synopsis of Clinical Investigation Plan (separate document, English + local language)
  • Patient related documents
    • Informed Consent Form(s) (ICF(s))
    • Recruitment material, flyers, posters
    • Diaries, questionnaires, interview topic list,…
    • Description of the compensation for trial participants
  • 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
    • 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
    • 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)
    • Signed Suitability of sites (Written Statement)
    • Insurance certificate (provided by HIRUZ CTU)