European Commission Publishes 20th Notified Body Survey Results under MDR and IVDR
The European Commission has published the survey results of the 20th Notified Body survey under the MDR and IVDR, with data status 28 February 2026.
The publication forms 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).
The survey was conducted in March 2026 and collected data from notified bodies designated under the Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746.
Survey Scope and Participation
The 20th Notified Body survey includes results from the small and medium datasets collected in March 2026.
According to the document, 53 out of 53 notified bodies responded to the survey, representing a 100% response rate. Of these notified bodies, 52 were designated under the MDR and 19 were designated under the IVDR.
The data cover notified body activities from designation up to 28 February 2026.
MDR Applications and Certificates
For medical devices under the MDR, the survey reports:
31,902 total certification applications lodged;
20,698 written agreements signed;
989 applications refused;
18,010 MDR certificates issued;
32,898 applications filed by annex.
The survey also reports that 12,036 QMS certificates and 6,203 product certificates had been issued under the MDR by 28 February 2026.
According to the survey, the main reasons for MDR application refusals were applications being outside the scope of the notified body’s designation and incomplete applications.
The survey also indicates that incomplete submissions remain a relevant issue, with only 14 out of 52 MDR-designated notified bodies reporting that more than 50% of submissions were complete.
IVDR Applications and Certificates
For IVDs under the IVDR, the survey reports:
3,723 total certification applications lodged;
1,813 written agreements signed;
145 applications refused;
3,418 IVDR applications;
2,318 IVDR certificates issued.
The survey also reports 1,040 QMS certificates and 1,302 product certificates issued under the IVDR.
For Class D devices, the survey reports 1,191 applications and 722 certificates by 28 February 2026.
The document also highlights applications and certificates requiring consultation for companion diagnostics, with 80 applications lodged and 30 certificates issued requiring consultation for CDx.
Certification Timelines and Submission Quality
The survey provides information on timelines for reaching a new MDR certificate.
For MDR QMS certificates, 62% of notified bodies reported a timeframe of 13 to 18 months to issue a new QMS certificate, while 30% reported 6 to 12 months.
For MDR QMS plus product certificates, the timeframe was generally longer, with 51% of notified bodies reporting 13 to 18 months and 31% reporting 19 to 24 months.
The survey also shows that incomplete submissions continue to affect both MDR and IVDR processes. For IVDR submissions, only 5 out of 19 notified bodies reported that more than 50% of submissions were complete.
Impact on Medical Device and IVD Manufacturers
For medical device and IVD manufacturers, the survey provides an important update on notified body activity and conformity assessment capacity under the MDR and IVDR.
Manufacturers should pay particular attention to:
early planning of MDR and IVDR submissions;
securing written agreements with notified bodies;
completeness and quality of technical documentation;
expected timelines for QMS and product certification;
application refusal risks;
conformity assessment strategy by annex;
Class D IVD and companion diagnostic requirements;
product portfolio planning and market availability.
The data also reinforces the importance of submitting complete and well-structured applications. Incomplete submissions remain a recurring issue and may contribute to delays, additional information requests or refusals.
For manufacturers, proactive engagement with notified bodies, strong regulatory planning and submission readiness remain essential to support timely certification and continued availability of devices on the EU market.
