Final report – according to IVDR
- Published: June 27, 2022
- Last updated: June 27, 2022
After completion of a performance study, the sponsor must compile a full report to be approved and signed by the principal investigator or the coordinating investigator if it is a multi-centre investigation.
The sponsor must submit a performance study report to the Swedish Medical Products Agency at the latest:
- one year after the end of the performance study, or
- three months after premature end or temporary halt of the performance study.
The minimum requirements for the content of the performance study report are listed in Section 2.3.3. of Part A of Annex XIII to the IVDR.
Additional guidance will be provided by the Commission and published here when available.
The performance study report shall be accompanied by a summary presented in terms that are easily understandable to the intended user of the in vitro diagnostic medical device.
Both the report and the summary will be made publicly accessible.
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