Performance studies on in vitro diagnostics (IVDR)
On 26 May 2022, the EU Regulation on Medical Devices for In Vitro Diagnostics, also known as the In Vitro Diagnostics Regulation (EU no 2017/746, IVDR) will come into effect. The IVDR contains specific rules for the submission, assessment and execution of performance studies on in vitro diagnostics, IVDs. On the CCMO website, the necessary information for researchers is available on the special theme page Performance studies for in vitro diagnostics as of 29 April 2022.
Performance studies on in vitro diagnostics are divided into different legal frameworks. These frameworks are described in Legislation and regulations, guidelines and standards .
For information about the submission and content of the research file, please visit the Primary Submission and Standard Research File page.
On the During and after page, you will find information about what to report during and after an IVD performance study.
- The client must submit a report on the performance study within one year of the end of the performance study. The requirements for the report are set out in Annex XIII of the IVDR (section 2.3.3 of Section A).
- The sponsor must submit a layperson summary of results within one year of the conclusion of the performance study.
- If it is not feasible for scientific reasons to submit the report and the lay summary within one year of the end of the performance study, the client must have laid down a different period with reasons in the plan for the performance study (Clinical Performance Study Plan — CPSP). The review committee assesses whether the extension of the term is justified.
- If the performance study been suspended or terminated prematurely, a period of three months instead of one year applies for submitting the report and the lay summary.
- If the performance study been suspended and restarted within three months, the client does not have to submit a report and a lay summary.
Once Eudamed is operational, the results of the performance study must be uploaded in Eudamed and the report and the lay summary will be made public via Eudamed (IVDR Article 73.7).
Information about starting an appeal or objection procedure against a decision by the accredited MREC or the CCMO can be found under Appeals and objections.