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).

D4.7.1/2 Synthesis of national requirements / Framework for the assessment of high-risk medical devices and in-vitro-diagnostics

The deliverable D4.7.1/2 Synthesis of national requirements / Framework for the assessment of high-risk medical devices and in-vitro-diagnostics is now finalized.

Below you can find the published documents:

This EUnetHTA 21 deliverable (D4.7.1/2) focusses on the synthesis of national requirements and the development of a framework for the assessment of high-risk medical devices and in-vitro-diagnostics.

The objectives of this deliverable are 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 joint clinical assessment reports early in the life cycle of a single technology (i.e., immediately or soon after CE marking, within the scope of the HTAR). The general rules laid down in the HTAR serve as specifications for this framework.
  • Provide general guidance for joint clinical assessments of single-technology CE-marked high-risk medical devices/in-vitro-diagnostics, with general principles, details on processes, work-step tasks and responsibilities, timing and points of interaction with stakeholders, and information requirements (submission dossier) from HTDs.

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

Comments Public Consultation for D4.7.1/2

Final Deliverable D4.7.1/2 Synthesis of national requirements / Framework for the assessment of high-risk medical devices and in-vitro-diagnostics

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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 closed.

Below you can find the published documentation:

D4.7.3/4 EUDAMED data reporting template / Guidance for EUDAMED-based TISP process – Project Plan

For any questions regarding this deliverable, please contact JCA_Secretariat@zinl.nl