The In Vitro Diagnostic Medical Devices Regulation (IVDR), Regulation (EU) 2017/746, has applied since 26 May 2022, replacing the long-standing In Vitro Diagnostic Directive (98/79/EC). It reshapes how diagnostic tests reach the European market, and its staggered transition deadlines are now arriving in earnest. For manufacturers of tests used across Greek and EU laboratories, understanding where each product sits on the timeline is no longer optional.
A risk-based framework
The IVDR moves away from the Directive’s list-based approach to a classification system built around risk. Every in vitro diagnostic is assigned to one of four classes, from Class A (lowest individual and public-health risk) to Class D (highest). The intended purpose of the device, not simply its technology, drives where it lands.
- Class A — low risk, such as instruments, specimen receptacles and general laboratory buffers.
- Class B — the default class for devices not captured by a specific rule, for example pregnancy self-tests.
- Class C — higher individual or moderate public-health risk, such as cancer markers and blood-glucose self-testing reagents.
- Class D — the highest risk, including tests for transmissible agents in blood, such as HIV and hepatitis assays.
The practical consequence is significant: under the Directive only a small minority of tests required an independent conformity check, whereas under the IVDR the large majority now need a notified body. Only non-sterile Class A devices may still self-declare.
The extended transition timeline
Because notified body capacity ramped up more slowly than anticipated, Regulation (EU) 2024/1860 (in force from 9 July 2024) extended the transitional periods to avoid shortages of critical diagnostics. Legacy devices already certified or declared compliant under the Directive may continue to be placed on the market until:
- 31 December 2027 for Class D devices;
- 31 December 2028 for Class C devices;
- 31 December 2029 for Class B and Class A sterile devices.
These extensions are conditional, not automatic. To benefit, manufacturers must have lodged a certification application and signed a written agreement with a notified body by set milestones — for Class D devices, by 26 May 2025 and 26 September 2025 respectively, with equivalent earlier deadlines for lower classes. A compliant quality management system must also be in place.
What compliance actually demands
Meeting the deadline is about more than a certificate. The IVDR raises expectations across the full lifecycle:
- Robust performance evaluation, drawing on scientific validity, analytical and clinical performance evidence.
- A quality management system aligned to the Regulation and, in practice, to ISO 13485.
- Strengthened post-market surveillance and performance follow-up.
- Unique Device Identification and registration obligations tied to the EUDAMED database.
Why early action matters
With notified body appointments and review slots in limited supply, the real bottleneck is not the December end-dates but the far nearer application and agreement milestones. A test whose evidence dossier is incomplete may miss its window regardless of the headline deadline, forcing it off the market. Portfolio triage — deciding which products to transition, reclassify or retire — is a strategic decision best taken early.
How PQRA helps
PQRA supports IVD manufacturers and their partners through every stage of the transition: classifying devices under the IVDR rules, gap-assessing technical documentation and performance evaluation, preparing quality systems for audit, and managing the notified body engagement and EUDAMED registration process. We help clients build a realistic, prioritised roadmap that matches each product to its deadline.
If your diagnostic portfolio needs an IVDR readiness review, get in touch with the PQRA team to discuss a tailored plan.
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