Reevaluation of Insurance application system (challenges) according to actual usage

Committee:
Medical Equipment
status:
Progress
Published:
The C1 and C2 challenge mechanisms, which allow for re-evaluation based on actual usage data, have been institutionalised. This has opened a pathway for company-initiated re-evaluations. When obtaining the right to challenge, submission of a research protocol is required, and in some cases, trials to verify additional clinical usefulness may take a significant amount of time.

Recommendations

  • The EBC recommends that the evaluation period required to obtain the right to challenge (under the C1 and C2 mechanisms) be set at three years.