Some of the required functionalities fall directly into the MDR definition. If PCP is an opportunity to test and accelerate the go to the market, does this mean that, as part of the PCP, the procurers will manage the clinical trial to obtain the CE mark?

Clinical trials for the CE mark – per se – do not fall in the field of this PCP. However, the supplier should explain in its offer the certification strategy that will be followed to obtain this CE mark after the PCP. This strategy should be part of the commercialization strategy of the developed innovative solution and it will be evaluated during the PCP.

Question number:

Date:

July 10, 2021

Asked via:

OMC RJH

Last updated:

July 29, 2021

Scope document for the OMC

If you would like to better understand what is expected in INCAREHEART have a look at this detailed description of the building blocks and use cases. Please note that this is draft information with the purpose of consulting the market and that it might differ from the final versions included in the Call for Tenders.

OMC Questionnaire

The OMC questionnaire aims to obtain market feedback on the planned PCP and assess existing solutions. The collected input will inform the ongoing tender specifications development. Let us know what you think before the 31st of August 2021.

If you are searching partners for a joint tender and would like to appear on the Matchmaking section of this website, you can register by completing the OMC questionnaire. This part of the questionnaire will remain open until the closure of the Call for Tenders.