15 Oct 2020

ISO 14155: 2020 Clinical investigation of medical devices for human subjects – Good clinical practice

The international standard ISO / DIS 14155 “Clinical investigation of medical devices for human subjects – Good clinical practice” has been revised as regards the design, the direction and the documentation of pre- and post-market clinical investigations carried out on human subjects to evaluate the clinical performance, efficacy and safety of medical devices.

Medical device manufacturers need to verify the actual possession of safety requirements with respect to their own products. In this context, clinical studies are an essential element in order to avoid risks and verify the real effectiveness of each technology. They are also fundamental for the doctor’s therapeutic choices as well as for health policy decisions, always inclined to balancing investments in innovation with special attention to costs containment.

This Regulation steers organizations towards a scientific, ethical and documentary arrangment of clinical investigations, whose impact goes far beyond obtaining the CE marking of the product.

ISO 14155: 2020 specifies general requirements intended to:

  • protecting the rights, safety and well-being of human subjects,
  • guaranteeing the scientific management of the clinical investigation and the credibility of the results of the investigation itself,
  • defining the responsibilities of the sponsor and the principal investigator,
  • assisting sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

This document does not apply to in vitro diagnostic medical devices. However, there may be situations, depending on the type of device and national or regional requirements, where the users of this document may consider whether specific sections and/or requirements may apply.

On the occasion of the revision of the aforementioned international standard, OPIS has proceeded with the purchase of the new manual, allowing its staff members to be updated on current regulations all the time and guaranteeing increasingly higher quality and efficiency standards.

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