The EU Commission Publishes Second Survey Results on Medical Device Availability

By Roxana Cernescu and Evangeline Loh

The Second Survey on Economic Operators (EO) was published (December 1) for survey responses collected between December 19, 2024 to March 21, 2025 (EUSurvey platform).

The data was validated for 254 respondents. The questionnaire consisted of 81 questions. Unfortunately, the commissioned study team declared that response rate and the number of EOs reached in total was unavailable. However, of the 254 manufacturers and Authorized Representatives (AR), 95% appeared to be voluntarily registered in the EUDAMED Actor Module. This is likely welcome news with Decision 2025/2371.

Second Survey results

In comparing the second EO Survey to the first manufacturer/AR survey (September 2024), in general, the time to prepare an application for the MDR is reported as 6-12 months. The second survey compared to the Notified Body survey (12^th), noted that the average time between lodged application and signed written agreement was 1-3 months. When these two data sets were compared again for the time to reach MDR QMS and product certificate, the time reported by the Notified Bodies (56%) was 13-18 months and greater than 19 months for manufacturers (58%). 

There is a tremendous number of data slides in the report. 

Reminder of the public dashboard

The Public Dashboard aggregates data from the surveys, interviews and MDCG Taskforce meetings. One example, under the MDR Outcomes tab, for the number of Notified Bodies taking on new clients (MDR), only 1 of the 50 responded “no.” There does not appear to be a Notified Body capacity issue. 

Health Service Providers Survey

In addition to this survey, there was a survey of Health Service Providers (HSP) (May 8). HSPs were surveyed between August 14, 2024 to October 31, 2024. The study team declared the survey not representative as it was difficult to reach the HSP groups with the survey. Of the 65 responses, only 55 were further used for data analysis. 

There is a tremendous amount of data available in the Second Survey on EO, Dashboard, and Notified Body Surveys.