D4.7.1/2 Synthesis of national requirements / Framework for the assessment of high-risk medical devices and in-vitro-diagnostics
This EUnetHTA 21 deliverable (D4.7.1/2) focusses on the synthesis of national requirements and developing a framework for the assessment of high-risk medical devices and in-vitro-diagnostics. The objective of this deliverable is to define the framework for joint clinical assessments of high-risk medical devices and in-vitro diagnostics with a view to foster national uptake of the assessment reports. This framework should include early assessment (after CE marking) in the life cycle of an individual technology (within the scope of the HTA regulation).
D4.7.1/4.7.2 – framework for assessing high-risk MD is closed.
Below you can find the published documentation:
Project Plan D4.7.1/2 Synthesis of national requirements / Framework for the assessment of high-risk medical devices and in-vitro-diagnostics
D4.7.3/4 EUDAMED data reporting template / Guidance for EUDAMED-based TISP process
This EUnetHTA 21 deliverable (D4.7.3/4) focusses on the European Database on Medical Devices (EUDAMED) data reporting template and guidance for EUDAMED-based Topic identification, selection and prioritisation (TISP) process. The objective of this deliverable is to:
The public consultation for this specific deliverable is now open until 05.07.2022.
D4.7.3/4 EUDAMED data reporting template / Guidance for EUDAMED-based TISP process – Project Plan
D4.7.3/4 EUDAMED data reporting template & Guidance for EUDAMED-based TISP process – Draft Deliverable
June Comment Form
For any questions regarding this deliverable, please contact JCA_Secretariat@zinl.nl
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