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Clinical Experimentation Medical Devices

A clinical investigation/trial regarding a medical device (MD) is any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device (Regulation (EU) 2017/745).

There are two types of clinical trials on medical devices: pre-market investigations and post-market investigations.

Pre-market investigations can be required for MDs not bearing the CE marking, with the purpose of generating data supporting their efficacy and safety, in order to market the MD in compliance with the regulatory requirements. Such requirements have become particularly strict when Regulation (EU) 2017/745 (Medical Device Regulation, MDR) has entered into application.

Post-market Investigations

Concerning post-market investigations, these are studies where the medical devices is already CE-marked, and undergoes a clinical trial in accordance the intended use for different types of confirmation (regarding safety, performance, acceptable risk/benefit profile, risk identification based on a large-scale or long-term use).

The need to carry out post-market clinical trials will become more and more frequent in this case as well, when the MDR is applied, as part of the Post-Market Clinical Follow-up (PMCF) to be implemented by manufacturers.

In case of medical devices not bearing the CE marking and intended for clinical trials, the sponsor, or alternatively, a legal representative established in the European Union, or one of their delegates shall submit a clinical trial application to the Italian Ministry of Health before starting the trial.

This application shall be submitted even in case the clinical trials concern intended uses of the device other than those being the subject of the CE marking, or if the MDs are already CE marked but were modified in their structure and composition.

In the case of medical devices bearing the CE marking, used in the study according to their intended use, all information regarding the start of the investigation should be sent to the Ministry of Health, according to the MDR provisions.

Both types of trial shall be submitted to ethics approval.

Di Renzo Regulatory Affairs has a special unit dedicated to clinical trials of medical devices, and can assist companies carrying out the following:

• investigation feasibility studies/rationale
• assistance in the start-up activities
• review of the study protocol
• review of the Investigator Brochure
• preparation of the clinical trial dossier for Ethics Committees and Competent Authorities (draft of the informed consent, information for patients, information for the treating physicians, etc.)
• submission of authorisation applications and exchanges with the Competent Authorities and Ethics Committees until the opinion to start the trial has been obtained
• notification about the start of post-marketing clinical investigations
• vigilance activities and collection of the reports on adverse events and incidents during the clinical trial
• supporting the manufacturer in the management of clinical trials
• drafting/review of statistical plans and statistical analyses on the collected data
• drafting of end-of-trial reports
• international contacts for the authorisation of trials to be carry out outside Italy.