Komissio on julkaissut uuden MDCG ohjeen. Info englanniksi jäljempänä
Newly published MDCG guidance 2022-19 (typo 2020) Performance study application/notification documents under Regulation (EU) 2017/746.
The includes template forms to be used by the sponsors of performance studies when making an application or notification to the Member State. These forms mimic the EUDAMED fields however, in its absence, the sponsor shall check if there are additional requirements for each State. Moreover, the guidance clarifies that the application should be submitted to the Member State where the study will be conducted.
The templates will be withdrawn once the EUDAMED module for performance studies is fully functional. Below is the latest timetable for the Clinical Investigation / Performance Studies (CI/PS) EUDAMED module that will host the applications once operational.
Ohje löytyy: https://health.ec.europa.eu/latest-updates/mdcg-2022-19-performance-study-applicationnotification-documents-under-regulation-eu-2017746-2022-12-12_en