New Health Technology Assessment Regulation

A new regulation on Health Technology Assessment (Regulation (EU) 2021/2282) has been adopted. This regulation aims to make vital and innovative health technologies, including certain medical devices and medical equipment, to be more widely available. The regulation will apply from January 2025 and supersedes the current system of project-based cooperation between EU Member States.

Health technology assessment (HTA) is a scientific evidence-based process that allows competent authorities to determine the relative effectiveness of new or existing health technologies. It focuses specifically on the added value of a health technology in comparison with other new or existing health technologies. This evidenced-based information is provided to policy-makers, so they can formulate health policies that are safe, effective, patient-focused and cost-effective. It is also used by national authorities to help decisions on which technology should be reimbursed at national level.

The health technology assessment regulation will apply to medical devices (class IIb or III) for which relevant experts panels have provided a scientific opinion on the clinical evaluation (article 51 and 54 of Medical Device Regulation (EU) 2017/745). It is also applicable to in vitro diagnostic devices (class D) for which the relevant expert panel has provided their view (article 47 and 48 of In Vitro Diagnostic Regulation (EU) 2017/746). The dossier requirements are defined in annex II of Regulation (EU) 2021/2282. The dossier focuses on clinical evaluation for medical devices and performance evaluation for in vitro medical devices. The dossiers will be assessed by a joint clinical assessment team.  

Regulation (EU) 2021/2282 can be found here:

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Bianca Lutters
Post date: February 14, 2022
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