Early Dialogues for Medical Devices
EUnetHTA multi-HTA Early Dialogues for Medical Devices (EUnetHTA multi-HTA EDMD) represent a single gateway for early dialogues with European HTA bodies (HTAB) on their evidence-generation plans for Medical Devices. EUnetHTA multi-HTA EDMDs involve HTAB, Industry and relevant stakeholders (notably patients and healthcare professionals).
The main benefits of EUnetHTA EDMD include:
The EDMD procedure lasts approximately 4 months with the following key steps:
The advice given during a EUnetHTA Multi-HTA EDMD:
The Early Dialogues for Medical Devices Working Party (EDMD WP)
The Early Dialogues for Medical Devices Working Party (EDMD WP) has been established by EUnetHTA to ensure robust high-quality HTA outputs for Medical Device EDs. Except in rare cases (i.e. product outside of HTAB remit) all EDMD WP members will systematically participate in EDMD. Currently, the EDMD WP is composed of the following HTA bodies: Current members of the EDMD WP are: AVAILA-T (ES), HAS (FR), NICE (UK), and RER (IT). The primary responsibilities of the EDMD WP include:
The EDMD WP aims to ensure the constant quality of EDs while providing sufficient flexibility to allow for participation of additional HTA bodies from across Europe. This will allow the participation of agencies of various sizes in the process, while ensuring that all contributors have the necessary level of expertise and comply with the JA3 procedures.
Once a decision is made regarding the acceptability of an EDMD request, the larger group of HTAB participating in EDMD analyse the request (together with the EDMD WP) against the EDMD Selection Criteria as defined below. If the request passes the selection criteria and at least 3 HTAB wish to participate in the EDMD, the request is accepted.
The final group of HTA bodies participating in a specific ED will constitute the ED specific Committee (EDC). This group is composed of the EDMD WP + any other participating HTA body. The EDC is led by the ED Scientific Coordinator for this ED. The make-up of the group will thus vary for each ED.
EUnetHTA Selection Criteria
EUnetHTA multi-HTA EDMDs are restricted to MDs classified as class IIb and III, in vitro diagnostic, equipment and digital healthcare solutions/connected devices and will be selected for an ED after measurement against the EUnetHTA selection criteria:
In addition to the above selection criteria, at least 3 HTAB must agree to participate in an ED for the request to be accepted.
How to apply for an Early Dialogue for a Medical Device
The following principles should be taken into account by Applicants willing to submit an ED request:
Companies wishing to apply for an Early Dialogue should complete a Briefing Book using the template provided below, and submit the document (including all necessary annexes and references) to the EUnetHTA ED Secretariat. In order to maintain the confidentiality of information provided by the Applicant, the exchange of all documents during an EDMD will be done through a secure file sharing system. Should the Applicant not have internally, please contact the EUnetHTA ED Secretariat via email (email@example.com) to establish a link using Sharefile.
Questions about EUnetHTA EDs should be directed to the EUnetHTA ED Secretariat (firstname.lastname@example.org).
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