EUnetHTA 21 released the assessment framework for high-risk medical devices and in-vitro-diagnostics

29

Aug 2022

On July 27, 2022, the EUnetHTA 21 released the assessment framework for high-risk medical devices (MDs) and in-vitro-diagnostics (IVDs). The key uptakes are provided below:

  • The objective of this deliverable is to define the framework for Joint Clinical Assessments of high-risk MDs and IVDs with a view to fostering national uptake of the Joint Clinical Assessments reports early in the life cycle of a single technology (i.e., immediately or soon after CE marking, within the scope of the Regulation (EU) 2021/2282 on health technology assessment (HTAR)). The general rules laid down in the HTAR serve as specifications for this framework.
  • The framework does not cover comparative assessment of multiple technologies for indication groups later in their life cycle (this is not within the scope for Joint Clinical Assessments in the HTAR) or collaborative assessments (CAs). However, CAs will be possible under HTAR and could be the opportunity to conduct a comparative assessment of multiple technologies later in their life cycle.
  • This guidance document on Joint Clinical Assessments of high-risk MDs and IVDs is one element of the framework for the assessment of high-risk MDs and IVDs, which includes the necessary templates (submission dossier for health technology developers and assessment report) and the related existing or new standard operating procedures (SOPs).
  • New methodological guidelines developed during the service contract will have been adapted to any kind of MD/IVD assessment.
  • This document provides general guidance for Joint Clinical Assessments of single-technology CE-marked high-risk MDs/IVDs, with general principles, details on processes, work-step tasks and responsibilities, timing and points of interaction with stakeholders, and information requirements (submission dossier) from health technology developers.

The full details in English can be found here.

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