The requirements of the research protocol/ Clinical Performance Study Plan are listed in section 2.3.2 of Appendix XIII of the IVDR.

CCMO has no specific IVDR Research protocol template. You may use the current WMO template research protocol and make the necessary adjustments yourself. It is not necessary to submit a Protocol Signature Sheet separately. This sheet is already included in the template. It is essential, however, that the protocol is signed by all parties.

Download the Research protocol template