An Investigator Initiated Trial or Study IIT/ IIS is a research effort in which the investigator designs and implements the clinical study and the investigator acts as the study sponsor. As the sponsor, the Investigator assumes all responsibilities for complying with applicable regulatory requirements. In accordance with GCP the results of the IIS will have to be made public through publication in a peer reviewed journal or via clinical trials database.
The position of small- and medium-size medical device manufacturers is that IIT/ IIS studies are a valuable and indispensable tool to collect clinical data with their (innovative) device that can be accessed in public domain at relatively low costs for the manufacturer.
What will be the impact of the EU MDR to IIT/IIS clinical data collection?
For the first time, the MDR has established the formal role of a sponsor as subject of medical device regulation. The sponsor is defined as any individual, company, institution or organization which assumes responsibility for the initiation, including management and arrangement of financing the clinical investigation.
Under the EU MDR the sponsor of an IIS might need to be concerned with Article 8 of the MDR.
MDR Article 8 Use of harmonised standards states that:
1.Devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the requirements of this Regulation covered by those standards or parts thereof.
This part also applies to (MDR Article 8):
economic operators or sponsors, including those relating to quality management systems, risk management, post-market surveillance systems, clinical investigations, clinical evaluation or post-market clinical follow-up (‘PMCF’).
If the information gathered under an IIT/ IIS will be considered for inclusion in a manufacturer’s clinical evaluation, the expectation appears to be that the MDR requirements are fulfilled only in case the Sponsor has applied the relevant harmonized standards regarding clinical investigation (ISO 14155) and risk management (ISO 14971).
The Notified Body may have questions regarding the IIT/IIS as a substantial piece of evidence in demonstrating conformity with the regulatory requirements. If the clinical investigation is not executed under the control of the manufacturer, how can GCP and compliance be assured by the manufacturer? Also, the Notified Body would need to understand: how does the ‘clinical investigation question’ relate to the manufacturers systematic approach of Clinical Evaluation, Risk management and Post market surveillance and Post market clinical follow-up? This may need careful explanation before the IIS clinical data can be used in the Clinical Evaluation of the device.
Because the EU MDR now clearly establishes the requirements for GCP and risk management, Qserve believes that if sponsors are adequately informed and trained, to complete IIT/ IIS in line with GCP and risk management requirements, this type of clinical data collection continues to be a valuable source of clinical evidence for medical device manufacturers.
Anna & Ellen