EUnetHTA aims to develop coordinated activities between the Competent Authorities, Notified Bodies and EUnetHTA – supported by the European Commission and in cooperation with stakeholders – in order to explore synergies (Early Dialogue/Scientific Advice, Post-Launch Evidence Generation/ Post Market Clinical Follow-up). To this regard, a dedicated EUnetHTA Task Force on HTA and Medical Device Regulation (MDR), led by AIHTA, Austria was created.
The background of this initiative is the effort of HTA agencies to reduce the evidence gap between market approval (CE marking) and market access (reimbursement and coverage decisions) for high risk medical devices (class IIb and III, IVD: C and D). Synergies in evaluation may contribute to provide early market access of safe and effective medical devices for patients, contain costs for healthcare systems and ease the burden of manufacturers to comply with different requirements across European countries.
To facilitate collaboration – three EUnetHTA workshops for Coordinated Activities on HTA and Medical Device Authorities were organised by AIHTA, Austria:
The documentation (slides and minutes) can be found here.
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