The In Vitro Diagnostic Regulation reshaped how diagnostics reach the EU market — and while transition deadlines have been extended, the conditions attached to them have already bitten.
Regulation (EU) 2017/746 (IVDR) became applicable on 26 May 2022, replacing the old IVD Directive. Its central change is scope: under the previous rules only around a fifth of diagnostics needed a notified body, whereas under IVDR the large majority do — a shift that created a structural capacity bottleneck.
The transition timeline
Regulation (EU) 2022/112 staggered the deadlines for legacy devices by risk class:
- 31 December 2027 — Class D (highest risk, e.g. blood-screening tests).
- 31 December 2028 — Class C.
- 31 December 2029 — Class B and Class A sterile.
These extensions are conditional: a fully IVDR-compliant quality management system had to be in place by 26 May 2025, with staggered notified-body application deadlines following. Miss those and the extension does not apply.
Classification drives everything
IVDR uses a rule-based A-to-D classification. Because class determines the conformity-assessment route and the evidence required, getting classification right at the outset is the single most important early decision — and a frequent source of costly rework.
EUDAMED is now live
Under Regulation (EU) 2024/1860, EUDAMED is rolling out module by module. Following a Commission Decision in late 2025, the first four modules — actor registration, UDI/device registration, notified bodies and certificates, and market surveillance — became mandatory from 28 May 2026, for IVDs as well as medical devices. Actor registration and a Single Registration Number are the gateway.
Simplification on the way
In December 2025 the Commission proposed a targeted revision to simplify the MDR and IVDR — introducing conformity-assessment timelines, harmonising notified-body practice and clarifying rules for AI-enabled devices. It is still a proposal, and adoption is expected only later; treat published timelines with caution.
How PQRA helps
PQRA supports IVDR classification, technical documentation, notified-body strategy and EUDAMED registration — so diagnostics stay on the market through the transition and beyond.
No responses yet