SHAIPED questionnaire to Notified Body
SHAIPED Stakeholder Survey
About this questionnaire
This questionnaire is part of the SHAIPED project, a European initiative exploring how EHDS-enabled health data access can support the development, assessment, and deployment of Medical Device Artificial Intelligence (MDAI) in Europe.
Within SHAIPED, this work focuses specifically on the role of Real-World Data (RWD) in MDAI post-testing stages - market certification, post-market surveillance, clinical follow-up, HTA, and reimbursement processes.
We are exploring how accessing high-quality RWD through services of the future Health Data Access Bodies (HDABs) may help address the challenges faced by MDAI stakeholders.
We welcome contributions both from experts with direct experience evaluating MDAI and from experts who may not yet have assessed these technologies but can provide valuable insights into how such processes should be shaped in the future.
The questionnaire contains 4 sections. Completing the questionnaire should take approximately 30 to 45 minutes.
The results will be made available in project deliverables published on the SHAIPED webpage, and we will also send the respective documents to the email address used to contact you.
You can find additional details on SHAIPED and our survey from the Participant information Sheet.
For any questions, please contact: info@shaiped.eu
Thank you very much for your time and for sharing your expertise!