A clinical trial is a study on humans aimed at discovering or controlling the clinical, pharmacologic and pharmacodynamic effects as well as the safety of one or more medicinal products, medical devices or diagnostic/therapeutic procedures and techniques, in order to detect their benefits and any possible adverse reaction.
A clinical investigation is often required for MDs which are not marked yet, in order to obtain the EC mark. When a medical device presents high risks or is very innovative, for instance, it is not enough to include an assessment of the literature clinical data in the TF, but a new trial could be necessary.
The manufacturer of medical devices with no EC mark and intended for clinical trials, or the European representative should submit a notification of the clinical trial to the Ministry of Health. The communication is due also if the clinical trials regards destinations of use which are different from those which were the subject of the EC mark or if the MDs are already EC marked but they were changed in their structure and composition.
The manufacturers, authorized representatives and other subjects sponsoring clinical trials with EC-marked medical devices (post marketing) and with a destination of use complying with the marking should communicate all information regarding the starting of the trial to the Ministry of Health.
The supporting tools to correctly design and carry out a clinical trial are the MEDDEV guidelines and the harmonized technical rules UNI-EN ISO 14155-1 and UNI-EN ISO 14155-1, defining the performance of clinical trials and the requirements for a clinical assessment plan (clinical protocol), respectively.
Di Renzo Regulatory Affairs set up a specific unit for the clinical trials of medicinal products and medical devices, including a graduate in Chemistry and Pharmaceutical Technologies, a physician and an experienced administrative clerk.
The activities offered by Di Renzo Regulatory Affairs in this field are the following:
- Assistance with the submission of authorization applications for clinical investigations with medical devices at the Ministry of Health and the Ethics Committees
- Communications of initiation of post marketing clinical investigations
- Assist the manufacturer in the management of clinical trials
- Regulatory updates.