Public Consultation – Early Dialogues for Medical Device Developers

Public Consultation – Early Dialogues for Medical Device Developers

Following on the successful launch of the JA3 procedures for European Network for Health Technology Assessment (EUnetHTA) Early Dialogues (ED) for Pharmaceutical products, EUnetHTA is pleased to announce the future launch of EDs for Medical Devices.

The procedure is a single gateway for early dialogues with European HTA bodies on their evidence-generation plans for medical devices. This initiative builds on previous pilots on early dialogues for medical devices including EUnetHTA JA2 and the SEED project financed by the European Commission.

The main benefits of the ED procedure include:

  • Streamlined procedure for applicants;
  • Increased mutual understanding and problem-solving ability between HTA bodies through a structured interaction;
  • Improved coordination with, and greater participation of HTA bodies in EDs through the a unique contact point: EUnetHTA ED Secretariat at HAS and the nomination of a Scientific Coordinator at the beginning of each ED;
  • The EUnetHTA ED Secretariat facilitates the centralised recruitment of HTA bodies. Patient representatives and healthcare professionals may also participate in the parallel consultation procedure on a routine basis so that their views and experiences are incorporated into discussions.

Please note that the procedure may evolve based on feedback received from participants (internal and external stakeholders) via a post-ED questionnaire.

The procedure will last approximately 4 months with the following key steps:

  • Briefing book submitted by Applicant;
  • Compiled List of Issues raised by HTAB;
  • Applicant’s written response to List of Issues and related slides for F2F Meeting;
  • F2F Meeting;
  • EUnetHTA Final Consolidated Written Recommendation sent to Applicant.

The procedure for Early Dialogues (ED) for medical devices and the related briefing book template are now open for public consultation through July 20, 2018.

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