Team NB survey shows slowdown in growth of MDR and IVDR certificates issued in 2025
A recent survey published by Team-NB reveals that the growth of certificates for the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) slowed in 2025 compared to previous years. Additionally, the staffing levels for notified bodies (NB) have decreased due to a reduction in workload.
In 2023, the number of MDR and IVDR certificates doubled, rising from 2,780 in 2022 to 5,627. A similar trend was observed in 2024, when the issuance of certificates rose from 5,727 to 11,292, doubling again. However, between 2024 and 2025, the number of certificates issued increased by only 45%, from 11,292 to 16,453, according to the survey from Team-NB (The European Association of Medical devices Notified Bodies).
According to a recent study by the consultancy EY for the European Commission, this slowdown in the medical device sector can be attributed to the complexities of MDR and IVDR. The study found that more than half of medical device companies in the EU have reduced their product portfolios in order to navigate these complexities (RELATED: EU-commissioned study finds MDR, IVDR have dampened medical device investment, Regulatory Focus, 19 January 2026).
The survey also indicates that, for the first time in over a decade, there was a decrease in the number of NB employees from 2010 to 2025. Specifically, there was an 8% reduction in internal employees responsible for conformity assessment and a 21% decrease among subcontractors.
“Notified bodies were forced to lay off staff in 2025 in order to maintain operations. These decisions were difficult,” according to a statement from Team-NB. “Furthermore, given that training a staff member requires an investment of 12 to 18 months, the resumption of activities cannot be immediate. To date, we continue to observe a decrease in the number of submissions received and therefore in the workload. This trend is expected to continue until the vote on the regulatory revisions. In this context, some bodies may be forced to close down.”
The survey also indicated that approximately 50.47% of micro and small manufacturers certified under MDR and IVDR were based in the EU, while 49.53% were located outside the EU.
The Team-NB statement highlighted that 65% of submitted MDR files lack at least half of the required information. The situation under the IVDR is not much better; the press release noted that the completeness of the submitted IVD technical documentation needs improvement, with 42% of files missing three-quarters of the required information.
Under the two regulations, a notified body must receive a complete technical review document before it can begin its review.
Additionally, the survey revealed that 85% of the issued certificates were for MDR, while 15% were for IVDR.
In 2025, a total of 1,090 certificates were withdrawn due to reasons including cessation of activity, failure to fulfill contractual obligations, financial difficulties, negative assessment results, customers refusing audits or being unreachable, the manufacturer ceasing production of the product, changes in the NB, or unsatisfactory results from unannounced audits.
In terms of the distribution of certificates across the different MDR conformity assessment modules, most (57%) were issued under Annex IX, Chapters I and III. MDR Annex IX and Chapters I and III define the mandatory Quality Management System (QMS) requirements and continuous surveillance procedures manufacturers must follow to achieve and maintain CE certification.
Further, 34% of certificates were issued under Annex IX, Chapter II, which covers the assessment of the technical documentation for medical devices. It outlines how NBs evaluate whether a device's design, manufacturing, and performance data comply with MDR safety standards.
In the context of IVDR, the distribution of certificates is as follows: 53% were issued under Annex IX, Chapter II, which covers the assessment of technical documentation for high-risk devices, while 41% were issued under Chapters I and II of Annex IX in the IVDR, which covers the standard conformity assessment route for medical device manufacturers. Chapter I covers the manufacturer's quality management system (QMS) while Chapter II governs the assessment of the device’s technical documentation.
The survey also noted that MDR and IVDR reviews typically take between 13 and 18 months.
Team-NB is the European Association of Notified Bodies for Medical Devices. Established in 2001, it is a non-profit organization that represents numerous independent organizations across Europe. These organizations are authorized to evaluate the safety and regulatory compliance of medical devices before they can be sold.
