The MDCG has released a guidance pertaining to Q&A on performance studies relating to IVDR. To offer some background to this document, this document is intended for sponsors of performance studies involving in vitro diagnostic medical devices (IVDs) conducted under Regulation (EU) 2017/746 (IVDR). It also provides relevant information for manufacturers supplying IVDs for use in performance studies that may be sponsored by other parties, as well as for sponsors of combined studies.
Throughout this document, the term “in vitro diagnostic medical device (IVD)” is used as defined in Article 2(2) of the IVDR—referring to both IVDs and their accessories.
It is important to note that the IVDR governs not only IVDs themselves but also applies to performance studies involving such devices and their accessories when conducted within the EU. However, it does not regulate clinical or laboratory methodologies, such as workflows or standard operating procedures used in laboratories. The scope of performance studies under the IVDR specifically pertains to device performance.
The term “performance study” is used throughout this document in accordance with Article 2(42) of the IVDR, which defines it as “a study undertaken to establish or confirm the analytical or clinical performance of a device.”
Sponsors should also be aware that the IVDR does not provide detailed provisions regarding ethical review of performance studies. Therefore, it is essential to consult national regulations concerning submissions to ethics committees, and wherever possible, ensure that both ethics committees and competent authorities have access to the same, up-to-date versions of all study documents.
This guidance is not exhaustive and should not be considered the sole source of information. Sponsors and manufacturers must also refer to other applicable legal requirements, standards, and guidance documents relevant to IVDs and performance studies. Additional guidance, including further questions and answers, may be issued in the future to supplement this document.
The guidance document can be accessed using the following link
