With the upcoming changes from the Directives (IVDD, MDD and AIMDD) to the Regulations (IVDR and MDR), manufacturers will be more frequently challenged to obtain clinical evidence for safety and performance of their devices, through clinical investigations or performance studies. Furthermore, the standards of quality and safety for medical devices will be raised, by setting, amongst other things, more stringent requirements for clinical testing. In general, clinical investigations performed on human subjects need to follow Good Clinical Practices (GCPs), such as those outlined in ISO 14155 and the Declaration of Helsinki.
Before initiating a clinical investigation, it is crucial to assemble solid data during the preclinical stages of device development. These include the design V&V phases, as well as preclinical animal testing, both of which are important steps to confirm the choice of selected materials (biocompatibility) and processes, before putting the device in contact with human subjects.

To obtain reliable data, that will allow a manufacturer to sustain performance and/or safety claims, it is important to properly plan and execute all stages of medical device development, from its initial design to V&V, preclinical testing and clinical studies. Over the years, Medidee has gained thorough expertise in the design and execution of these important steps. Medidee support the manufacturer in:

  • Designing V&V stages of device development, according to device-specific ISO standards or requirements
  • Planning of preclinical animal studies, as per GLP
  • Preparing a Clinical Investigation Plan (CIP), as per EN ISO 14155 and applicable national laws
  • Structuring and filling Investigational Brochure (IBs), containing a compilation of the clinical and nonclinical data on the investigational product(s), as per EN ISO 14155
  • Preparing patient related documentations
  • Adjusting Case Report Forms (CRFs)
  • Submitting study relevant documents to Ethics Committee(s) and Competent Authorities
  • Analyzing preclinical and clinical data and writing clinical investigation reports
  • Monitoring clinical studies