European Commission Publishes Third Survey Results on Medical Device Availability in the EU
The European Commission has published the study overview and survey results of the 3rd Economic Operators survey, with data status 31 October 2025, as part of the study supporting the monitoring of the availability of medical devices on the EU market.
The study was commissioned by the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) via the European Health and Digital Executive Agency (HaDEA). Its aim is to support the monitoring and analysis of the availability of medical devices on the EU market in the context of the implementation of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).
Scope of the Survey
The study covers both medical devices and in vitro diagnostic medical devices, including devices already placed on the market under the new regulations and devices intended to be placed on the market in the future.
The survey also considers legacy and new devices, all risk classes, and focuses in particular on devices requiring notified body involvement, as well as special product groups such as orphan or niche devices and devices at risk of shortage.
The geographic scope covers 31 countries, including the 27 EU Member States, Iceland, Liechtenstein, Norway and Turkey.
Survey Participation
The third EO survey was launched on 15 January 2026 and closed on 19 March 2026, with data requested up to 31 October 2025.
In total, 216 replies were received, of which 213 responses were considered for data analysis after excluding duplicate submissions.
Of the 213 replies:
152 indicated acting as manufacturers of medical devices;
49 indicated acting as manufacturers of IVDs;
36 indicated acting as authorised representatives.
The survey also notes that 76% of responding companies had fewer than 250 employees, and 57% represented small and micro companies.
Key Findings for Medical Devices
For medical devices, the survey reports 1,319 applications lodged under the MDR by the end of October 2025, including applications with issued certificates, ongoing applications and applications that were eventually refused.
The survey also reports 772 certificates issued for medical devices under the MDR.
Regarding notified body agreements, almost all responding medical device manufacturers had one or more written agreements with notified bodies. According to the survey, 90% of medical device manufacturers had written agreements with notified bodies, while 7% of manufacturers requiring a written agreement did not have one.
Key Findings for IVDs
For IVDs, the survey reports 1,251 applications lodged under the IVDR by the end of October 2025, including 236 applications for changes.
The document also reports 357 certificates issued for IVDs under the IVDR.
The survey indicates that 49% of IVD manufacturers responding to the survey had already received certificates under the IVDR by 31 October 2025, while 51% had not.
The document also highlights discontinuation trends for IVDs. According to the survey, 61% of IVD manufacturersreported having stopped the production, marketing or supply of some IVDs to the EU market since 2022. In addition, 45% indicated plans to discontinue some IVDs on the EU market in the coming months.
Impact on Medical Device and IVD Manufacturers
For medical device and IVD manufacturers, the survey provides an important snapshot of the ongoing transition to the MDR and IVDR and the availability of devices on the EU market.
Manufacturers should pay particular attention to:
MDR and IVDR application planning;
notified body capacity and written agreements;
certification timelines;
certificate issuance and renewal;
product portfolio decisions;
discontinuation of devices;
availability of orphan, niche or at-risk devices;
EUDAMED registration and regulatory readiness.
For IVD manufacturers, the results are particularly relevant given the reported number of IVDR applications, certificates issued and discontinuation trends. These findings reinforce the need for early regulatory planning, proactive notified body engagement and careful assessment of product portfolio continuity under the IVDR.
For manufacturers of medical devices, the survey highlights the continued importance of written agreements with notified bodies, conformity assessment planning and monitoring of MDR certification progress.
