Study supporting the monitoring of availability of medical devices on the EU market

In December 2022, the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) - via the European Health and Digital Executive Agency (HaDEA) - has contracted a “Study supporting the monitoring of availability of medical devices on the EU market” to a consortium led by the Austrian National Public Health Institute (Gesundheit Österreich GmbH / GÖG), in collaboration with Areté and Civic Consulting. The study will be running for 36 months (December 2025).

Objective

The general objective of the study is to monitor and analyse the availability of medical devices on the EU market in the context of the implementation of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

Consultation activities

Relevant stakeholders will be mapped and consulted, and information needs as well as data sources will be identified. The study team will also design and establish a dashboard to gather the data retrieved and, based on feedback received, identify obstacles that could affect availability of devices and/or impair the conformity assessment process, pointing to potential solutions. The study requires therefore the contractor to approach stakeholders for several consultation activities, including surveys and interviews.

Notified bodies

Timetable: 

Survey timetable for notified bodies 2023
Survey timetable for notified bodies 2024

Survey results on certifications and applications (MDR/IVDR):

Data collected between March and July 2023 by the study team ("MD Availability Study")
Data collected between February 2021 and October 2022 by the European Commission ("EC")

Manufacturers and authorised representatives

Link to the survey: https://ec.europa.eu/eusurvey/runner/MFandAR
Survey deadline: 15 January 2024 (23:59 CET)

pdf version of the survey

EC endorsement letter

SAVE-THE-DATE 
Webinar with the study team with details on the survey background and the survey structure: 
Thursday, 7 December 2023, 1-2pm CET (no registration needed)
https://us02web.zoom.us/j/85169178337?pwd=Qy94NFZwa2M0VWZpYWxyc0JCK3h3UT09 
Meeting ID: 851 6917 8337, Passcode: 442308

 

Glossary

Working definitions of terms for the "Study supporting the monitoring of availability of medical devices on the EU market"

One-pager about the study and its content

One-pager (long version)

Dashboard

Link to the dashboard will be added.

Instructions for use for the dashboard of the “Study supporting the monitoring of avail-ability of medical devices on the EU market”

Contact

Should you have any questions, please do not hesitate to contact the study’s Project Manager Friederike Windisch (medical.devices@goeg.at).