Notified Body Survey on Applications and Certificates under the MD/IVD Regulation

A 2023 EU Commission survey of 39 notified bodies assessed certifications and applications under the Medical Device and In-Vitro Diagnostic Regulations (MDR/IVDR). The survey, running from December 2022 to December 2025, offers insights into the availability of medical devices and diagnostics. Data from July 2023 shows 29 bodies accredited under MDR, 9 under both MDR and IVDR, and one under IVDR.

MDR application rejections were mainly due to out-of-scope submissions (47%) or incomplete applications (27%). Certification timelines reveal that 45% of notified bodies issue quality management system (QMS) certificates within 6-12 months, while 39% take over 13 months. For both QMS and product certificates, 71% of bodies require 13 months or more.

The survey also provides details on in-vitro diagnostics, and the full results can be accessed on the EU website, along with a dashboard tracking device and IVD availability in the EU.