D4.7 High-Risk MD Framework

D4.7

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:

  • Explore other sources of information (e.g. horizon scanning documents) for identifying products (class IIb/ III medical devices and class D in-vitro diagnostics). In case EUDAMED is not fully operational in 2022 (current date of launch is May 2022), or if not sufficient information in enough detail is available for the public or to HTA bodies, a back-up strategy needs to be prepared. 
  • Develop and define a process description for screening of EUDAMED.
  • Develop and define a EUDAMED-based process description for TISP.

The public consultation for this specific deliverable is now open until 05.07.2022.

Below you can find the published documentation:

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