C1. Research protocol
The requirements of the research protocol/CIP can be found in Chapter II, Section 3 of Annex XV of the MDR and in Annex A of the ISO14155 (2020).
Guidance on the content of the clinical investigation plan can be found in MDCG 2024-3.CCMO has no specific MDR Research protocol template. You may use the current WMO model research protocol and make the necessary adjustments yourself.