Table 2.

Challenges with CED schemes for medical devices^a

	Challenge
1	Deciding which medical devices are candidates for CED schemes
2	Obtaining stakeholder agreement on the scheme
3	Securing funding for the scheme
4	Determining the appropriate study design for data collection
5	Determining the relevant outcome measure(s) on which data are collected
6	Dealing with data collection and monitoring
7	Dealing with data analysis
8	Ex-ante definition of decision rule, based on possible outcomes of the scheme
9	Reaching an agreement on price, reimbursement or use of the device at the end of the scheme
10	Withdrawing a device from the market when evidence indicates the device is not (cost-) effective
11	Obtaining agreements about the duration of the scheme and the stopping rule
12	Adapting the scheme to account for product modifications or a learning curve
13	Dealing with the market entry of similar devices

CED coverage with evidence development

^aDerived from Reckers-Droog et al. [17]