Health Technology Assessment and Clinical Studies - From development to reimbursement: Basic knowledge for innovators
According to the European Medical Device Directive 93/42/EEC, suitability for intended use must be established for all medical products. This requires the submission of a clinical evaluation based on data from scientific literature, research and testing or clinical studies. Regulatory changes increasingly prefer clinical studies.
The clinical evaluation is part of the technical file, and is submitted to the notified body as part of the official approval process, regardless of the product's risk category. In order to set up a clinical study, experts from the device manufacturer and clinicians have to work hand-in-hand. The first part of the course focuses on basic knowledge about clinical evaluations and clinical studies.
The requirements faced by applicants seeking reimbursement for medical services are becoming increasingly extensive and complex. National databases recording resource consumption as well as published tariffs are indispensable tools when preparing the mandatory documents for such reimbursement claims, e.g. health cost dossiers, models and pricing reports. The second part of the course focuses on existing public databases relevant to regulatory matters, as well as on the subsequent approval process up to and beyond the CE stage. Participants will learn about basic requirements, set-up, execution and interpretation of the results of clinical evaluations and clinical studies. The course will present precise and detailed information on available databases in order to facilitate the preparation of successful reimbursement documentation, e.g. health technology assessment (HTA) reports, cost dictionaries, HE models and value dossiers. |