ARTICLE SUMMARY:
The assessment bodies say they are laying off staff in the face of a decline in MDR/IVDR submissions from industry. One contributing factor, they claim, is device firms are holding off on sending full technical files until they know the outcome of pending regulatory reforms to streamline requirements.
After years of ramping up to address escalating EU regulatory demands, notified bodies now say they are cutting staff, citing a drop-off in incoming Medical Device and IVD Regulation review work from industry.
“Technical resources are overstaffed due to the suspension of manufacturers' applications and the postponement of ongoing procedures,” TEAM-NB stated in a release announcing its latest member survey results, reporting an almost 13% drop in full-time equivalents in 2025 among its 41 members (of the 52 total MDR- and IVDR-designated bodies).
The assessment bodies say they don’t expect an immediate turnaround, suggesting that many device firms are holding off submitting full technical files while waiting on the outcome of pending legislative MDR/IVDR reforms.
“This trend is expected to continue until the vote on the regulatory revisions,” TEAM-NB writes. “In this context, some bodies may be forced to close down.”
