Guide
EU IVDR: A Readiness Path Through the 2027 and 2028 Deadlines
Regulation (EU) 2017/746 (IVDR) replaced the In Vitro Diagnostic Directive (IVDD 98/79/EC) and reshaped the European IVD market — most IVDs that were self-certified under the IVDD now require notified body involvement, performance evaluation expectations are an order of magnitude tighter, and the transition deadlines staged through 2027 and 2028 are the gating dates for most manufacturers. This guide walks through the classification rules, the performance evaluation evidence expected, the role of EU reference laboratories for Class D, the technical documentation structure, and a practical readiness plan that respects the extended deadlines without sleeping through them. It is written for regulatory affairs, QA leads, clinical performance specialists, and product managers at IVD manufacturers.
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Classification: from list-based IVDD to risk-based IVDR
The IVDD classified IVDs by appearance on Annex II lists; the IVDR uses seven rules in Annex VIII to assign each device to Class A, B, C, or D based on the risk to the individual and to public health. The shift means that the majority of devices self-certified under the IVDD now sit in Class B or higher and require notified body conformity assessment. Companion diagnostics are Class C by Rule 3(g); devices for transmissible-agent screening or for life-threatening infectious-disease detection are Class D. Manufacturers who assume their old IVDD classification carries over typically discover during gap analysis that they need notified body involvement they had not budgeted for.
Performance evaluation: scientific validity, analytical performance, clinical performance
Article 56 and Annex XIII require a Performance Evaluation Plan and a Performance Evaluation Report covering three pillars: scientific validity (the association of the analyte with the clinical condition or physiological state), analytical performance (sensitivity, specificity, trueness, precision, LoD, LoQ, measuring interval, linearity, interfering substances), and clinical performance (clinical sensitivity, clinical specificity, predictive values, likelihood ratios). The PEP/PER must be updated throughout the lifecycle through the Post-Market Performance Follow-up Plan and Report (PMPF). The bar is materially higher than IVDD self-certification ever required, and notified bodies are rejecting PERs that recycle IVDD-era performance data without the IVDR-specified analytics.
Technical documentation: Annex II and Annex III
Annex II is the technical documentation for conformity assessment — device description, intended purpose, classification rationale, design and manufacturing information, GSPR conformity, performance evaluation. Annex III is the technical documentation on post-market surveillance — PMS plan, PSUR for Class C and D, summary of safety and performance (SSP) for Class C and D published on EUDAMED. Notified bodies expect both Annexes assembled as the manufacturer's living quality records, not as one-time submission packages. The SSP in particular is a public document, and many manufacturers underestimate the precision required given that competitors, clinicians, and patient groups will read it.
Class D: EU reference laboratories and common specifications
Class D devices — the highest-risk IVDs — face additional Article 48(5) and Article 100 controls including batch testing by an EU reference laboratory (where designated) and conformity to Common Specifications where adopted. The EU reference laboratory network became operational in stages from 2023; for designated device categories the EURL verification is a release gate, and the manufacturer's release process must integrate it. Common Specifications, once adopted, become mandatory unless a manufacturer can justify equivalent or better technical solutions in the technical documentation.
Transition deadlines: the 2027 and 2028 cliff edges
Regulation (EU) 2024/1860 extended the IVDR transition for compliant legacy devices — Class D until 31 December 2027, Class C until 31 December 2028, Class B and Class A sterile until 31 December 2029 — provided manufacturers have a QMS in place by 26 May 2025 and have applied to a notified body and signed a written agreement by specified intermediate dates. The extensions buy time but introduce new gating dates that several manufacturers have already missed. A 2026 readiness plan must work backwards from the deadline applicable to the highest-class device in scope.
A 90-day readiness sprint
Days 1 to 15: classification audit across the portfolio under Annex VIII; identify devices that change class or route; map deadlines per device. Days 16 to 45: rebuild the PEP/PER for the priority Class C or D device with full scientific-validity, analytical-performance, and clinical-performance evidence; populate Annex II to the level a notified body will accept. Days 46 to 70: stand up the PMS plan, the PSUR template, the SSP drafting workflow; wire post-market signals into the PMPF queue. Days 71 to 90: notified body engagement — book the slot if not already booked, deliver the technical documentation for pre-assessment, capture findings; roll the pattern to the next priority device.
Where this lives in V5 Ultimate
The clauses above aren't theoretical — every one maps to a shipped module and an industry profile. Jump to the parts of the product that turn this guide into evidence on a Monday morning.
Modules that do the work
Quality management
ISO 13485-aligned QMS as the IVDR Article 10(8) foundation.
Document control
Annex II and Annex III as live, versioned composites.
Vigilance & CAPA
PMS signals routed into PMPF and the PER update loop.
Compliance self-assessment
Score readiness against the IVDR transition gates per device.
Supplier qualification
Critical supplier control to the standard notified bodies expect.
Industries this hits hardest
Frequently asked
Does the extended IVDR transition apply automatically?
No. To benefit from the 2027/2028/2029 extensions under Regulation (EU) 2024/1860, manufacturers must have a compliant QMS in place by 26 May 2025 and meet intermediate dates for the formal application to a notified body and the signed written agreement. Missing those intermediate dates removes the extension and brings the original 26 May 2022 expiry of the IVDD certificate back into force.
Are in-house tests (LDTs) in scope of IVDR?
Yes — Article 5(5) covers in-house devices manufactured and used within health institutions in the EU, with specific requirements including a documented justification that no equivalent CE-marked device on the market meets the need at an appropriate performance level. Most provisions of Article 5(5) became applicable in May 2024 with a further extension for documentation under Regulation (EU) 2024/1860.
What is EUDAMED's role under IVDR?
EUDAMED is the European database for medical devices and IVDs. Its modules for actors, UDI/devices, notified bodies and certificates, and vigilance and PMS are progressively becoming mandatory. The Summary of Safety and Performance (SSP) for Class C and D IVDs is published in EUDAMED; UDI registration is required for all classes.
How does IVDR interact with ISO 13485 and ISO 14971?
ISO 13485:2016 is the harmonised QMS standard for IVDR Article 10(8); ISO 14971:2019 is the harmonised risk management standard for the GSPR risk clauses. Both give presumption of conformity to the corresponding IVDR requirements. A defensible IVDR programme runs the QMS on 13485, the risk file on 14971, and the IVDR-specific obligations (PEP/PER, PMPF, SSP, UDI/EUDAMED) on top.
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