“ISO 20916 – In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice” was published in May 2019.
This document defines good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes. This is the first edition of the standard and covers all the stages of the study, from the planning to the final report.
Because of an extensive need for harmonization clearly expressed by the European Union, ISO 20916 was included in the draft standardization request to support regulatory requirements on clinical performance studies, as also mentioned in the In Vitro Medical Device Regulation (IVDR).
The new standard finally gathers the requirements for IVD manufacturers in one single document – while previously manufacturers had to review country-specific regulations or evaluate the applicability of other documents. The main body of the standard includes 9 annexes, providing additional requirements and recommendations. A flowchart is provided to ease the navigation through the document.
ISO 20916 identifies the principles that underpin clinical performance studies and specifies general requirements intended to:
· ensure the conduct of the clinical performance study will lead to reliable and robust study results,
· define the responsibilities of the sponsor and principal investigator,
· assist sponsors, clinical research organization, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of IVD medical devices,
· protect the rights, safety, dignity and well-being of the subjects providing specimens for use in clinical performance studies.
Analytical performance studies are instead out of the scope of this document.
What does this mean for you?
It is highly advisable to adhere to this standard for all your clinical performance studies.
DPM of VIP Department
Obelis Expert Consultants, with more than 30 years of experience with EU regulatory affairs, will gladly answer your questions and assist you in ensuring compliance of your IVD medical devices.