Perspectives
Capacity with rigor, an argument in public
EU medical-device conformity assessment is under structural strain. The crisis is not a shortage of standards. It is a shortage of usable expert time, and AI will deepen that gap unless assessment infrastructure keeps pace with product creation.
We exist to expand capacity without automating judgment. Perspectives is where we develop that thesis carefully.
Evidence, not alarmism
- MDR applications (cumulative, EU/EEA)
25,978 MDR applications
MDR applications (cumulative, EU/EEA)
Team-NB Survey 2025 · Team-NB Survey 2025 (opens in a new tab)
- MDR certificates issued
13,953 MDR certificates
MDR certificates issued
Team-NB Survey 2025 · Team-NB Survey 2025 (opens in a new tab)
- New MDR certificate time bands
62% at 13+ months
New MDR certificate time bands
Team-NB Survey 2025 (13-18 mo + 19-24 mo + 24+ mo) · Team-NB Survey 2025 (opens in a new tab)
- Technical documentation assessment
21.8 months avg. TDA
Technical documentation assessment
Manufacturer-reported (MedTech Europe 2024) · MedTech Europe 2024 (opens in a new tab)
How the load evolved
Designated MDR Notified Bodies rose from 18 (2020) to 52 (2025). Applications still lead certificates; 2025 certificate growth slowed after two doubling years.
- Applications
- Certificates
| Year | Applications | Certificates | Designated MDR NBs |
|---|---|---|---|
| 2020 | 1,661 | 180 | 18 |
| 2021 | 4,666 | 892 | 25 |
| 2022 | 9,615 | 2,439 | 36 |
| 2023 | 14,539 | 4,873 | 42 |
| 2024 | 20,935 | 9,683 | 50 |
| 2025 | 25,978 | 13,953 | 52 |
Source: Team-NB Medical Device Survey 2025 (opens in a new tab). Cumulative member-reported totals; not a full EU census. Time-to-cert bands and completeness friction remain sticky even as designation and certificate volume grow.
Mission series
One company argument across distinct angles. Pieces stand alone; the recommended path follows the series order.
- A
The certification system under load
Demand, timelines, and policy extensions show structural strain in medical-device conformity assessment: not a temporary inconvenience.
Read essay · 7 min
- B
Where expert time actually goes
Capacity is usable expert time. Completeness friction, coordination, and reconstruction consume judgment hours before assessment begins.
Read essay · 9 min
- C
Binding assessment timelines
Implementing Regulation (EU) 2026/977 sets legally binding maximum durations for Notified Body conformity-assessment stages, including 90 days for product verification, not for the whole certification path.
Read essay · 7 min
- D
Consistency without conformity of thought
Variance between reviewers and organizations is a system design problem. Judgment should remain human; frameworks should not be improvised.
Read essay · 8 min
- E
The AI acceleration gap
Generative tools speed creation; assessment does not automatically follow. AI-enabled devices add complexity without erasing multi-month clocks.
Read essay · 8 min
- F
Human-in-the-loop, redefined for regulated assessment
Accountable assistance means authority, inspectability, and disposition control: not a checkbox next to an opaque model.
Read essay · 6 min
- G
Infrastructure for judgment
The operating conclusion: expand capacity without automating judgment. What better assessment infrastructure should make possible, and what it must not claim.
Read essay · 5 min
- H
Transparency is not a banner
The EU AI Act names obligations many assessment tools should have adopted anyway: and draws a line between AI in devices and AI in the work of judging them.
Read essay · 6 min
A seven-part mission series (A-G) and a regulatory coda (H), not a high-frequency content mill. Grounded in official sources and written for the EU institutions - Notified Bodies and authorities - that carry assessment risk.
The next generation of devices needs an assessment system ready to meet it.
If the series reflects your institution's reality, explore how the argument operationalizes in TDVeriX Med, or talk to us about your assessment workflows.