Regulators – Other Technologies
Collaboration with Competent Authorities/Regulators and Notified Bodies
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:
- 1st Workshop on 29.05.2018: this EUnetHTA meeting intended to start exploring the possibilities of a continuous exchange and cooperation between EUnetHTA, Competent Authorities responsible for medical devices, and Notified Bodies.
The documentation (slides and minutes) can be found here.
- 2nd Workshop on 28.05.2019: this EUnetHTA meeting focused on the perspectives of different stakeholders on collaboration on medical devices in light of the MDR. The meeting featured voices from the HTA community, industry (MedTech Europe), payers, and patients (EPF).
The documentation (slides and minutes) can be found here.
- 3rd Workshop (online) on 04.11.2020: besides an update on the progress in implementation of the MDR/in vitro diagnostic regulation (IVDR) and on the status quo of the proposal for a regulation on health technology assessment in the European Union, this EUnetHTA e-meeting initiated a dialogue on the evaluation of software as a medical device.
The documentation (slides and minutes) can be found here.
