Survey results of the 14th NB survey (MDR/IVDR)
Most resent intermediate results highlight the ongoing status of certification applications
All 51 notified bodies designated under MDR and/or IVDR as of 3 March 2025 participated in the survey (100% response rate)
The recent survey shows that 2.3% of MDR applications are formally rejected on application but this figure barely scratches the surface of gaps in technical documentation submitted for assessment When we combine the NB data with industry analyses (MedTech Europe, regulatory consultancies, NB commentary) a much clearer picture emerges
Whats’s really happening with first-time MDR submissions?
- Only 42-45% of applications are likely to pass cleanly on their first full review.
- 2.3% are outright rejected (official NB data)
- 20-50% of submissions require major rework, face significant NB challenges or are withdrawn/terminated before certification.
- 50% of manufactures report costly delays or negative outcomes due to CER/clinical evaluation pushback.
- 77% state their second submission is significantly smoother, confirming that first time readiness is the biggest hurdle.
If you look at these figures it’s clear what is driving first time submission failure:
- Incomplete Technical Documentation
- Weak clinical evidence
- PMCF misalignment or insufficient data
- QMS findings/non-conformities
- Unclear risk management
- NB code/scope mismatches
- Extended NB questions delaying evaluation
We at Starodub can help manufacturers minimise these risks through:
- Preforming MDR gap assessments
- CER and PMCF strategy support
- Technical documentation structuring and completeness checks
- NB communication and code/scope selection support
- First-time right submission planning
So, if you are preparing your first MDR submission or facing unexpected NB questions Starodub’s team of experts can help you avoid costly loops and move confidently toward successful certification and compliance
Starodub’s “first time right” submission approach and maturity in now one of the biggest predictors of MDR success.
Contact us directly by mailing your enquiry to [email protected] or visiting our website https://www.starodub.nl/Together we are stronger
