How do IVD manufacturers achieve IVDR compliance in time?
We guide manufacturers of in vitro diagnostics through the In Vitro Diagnostic Regulation (EU) 2017/746, from classification under Annex VIII through performance evaluation and technical documentation to certification by the notified body and EUDAMED registration. The extended transition periods come with conditions: without a timely application and a signed agreement with the notified body, legacy status ends early. And the IVDR obligations for post-market surveillance and vigilance already apply to existing products today, not only once the new certificate is issued.
- IVD
Overview
What requirements does the IVDR place on IVD manufacturers?
Support across all classes A–D · IVDR (EU 2017/746), ISO 13485:2016, ISO 14971:2019
Last updated: 2026-06-12
The In Vitro Diagnostic Regulation (EU) 2017/746 has replaced Directive 98/79/EC (IVDD) and fundamentally tightened the requirements for in vitro diagnostics. The five levers on which IVDR projects most often get stuck:
- Risk-based classification into classes A to D under Annex VIII: according to industry estimates, around 85 percent of IVDs require a notified body under the IVDR, whereas under the IVDD the majority were self-certified.
- Performance evaluation under Art. 56 and Annex XIII with three pillars: scientific validity, analytical performance and clinical performance, documented in the Performance Evaluation Report (PER). Clinical performance is the largest evidence gap for many existing products.
- Complete technical documentation under Annexes II and III, consistently linked to the General Safety and Performance Requirements (GSPR) of Annex I, plus risk management under ISO 14971:2019, UDI labelling and EUDAMED registration.
- Staggered transition periods under Art. 110, amended by Regulations (EU) 2022/112 and (EU) 2024/1860: the extension applies only under certain conditions, including a QMS under Art. 10(8), in practice implemented in accordance with ISO 13485:2016, and a timely application to the notified body.
- Scarce capacity: only a few notified bodies are designated for the IVDR, and certification procedures currently take 18 to 36 months.
Services
How we support you
Portfolio classification & gap analysis
Classification of the entire IVD portfolio according to the rules of Annex VIII with a documented rationale for each product, target-actual comparison against the IVDR requirements, and a prioritized action plan.
Performance evaluation & performance studies
Performance Evaluation Plan and Performance Evaluation Report (PER) under Art. 56 and Annex XIII, assessment of the evidence gaps per pillar, and planning of clinical performance studies in accordance with ISO 20916:2019, including a PMPF plan.
Technical documentation & GSPR
Building and maintaining the technical documentation under Annexes II and III, GSPR checklist under Annex I with concrete evidence for each requirement.
Learn more →Transition strategy & notified body
Deadline roadmap per product class under Art. 110 as amended by Regulation (EU) 2024/1860, preparation of the application dossier and support through to the signed agreement and through the audit.
EUDAMED & UDI
Registration of actors and products in EUDAMED, UDI assignment and implementation of the labelling obligations.
Learn more →Post-market surveillance & vigilance
PMS plan and PSUR under Art. 78–81, building the reporting system under Art. 82 ff., including the obligations that already apply to legacy products.
Learn more →How we work together
What it comes down to
The In Vitro Diagnostic Regulation (EU) 2017/746 has reversed the guiding principle of IVD regulation: under Directive 98/79/EC, self-certification was the norm; under the IVDR, it is the exception. Three strands shape every IVDR project, and their order is not negotiable. Classification under Annex VIII determines which conformity assessment route applies and which deadline regime under Art. 110 takes effect. Performance evaluation under Art. 56 and Annex XIII sets the pace of the project through its slowest pillar, clinical performance. And the capacity of the notified body is the external constraint that no manufacturer can steer themselves, only reserve early.
Regulation (EU) 2024/1860 has tightened this logic, not eased it: the extended deadlines apply only to manufacturers who have built a QMS, submitted the application and signed the written agreement with the notified body in time. That is why our work begins with portfolio classification and the gap analysis: they make visible which product has which deadline and where clinical evidence is missing, before documentation is written and audit capacity is booked. This shifts corrections to the start, where they are cheap, instead of into the assessment, where they cost months.
Our approach
Our approach
Step
Result
Portfolio classification
Confirmed risk class A to D under Annex VIII for each product, with a documented rationale and the derived conformity assessment route.
Gap analysis
Prioritized action list: where documentation, evidence and the QMS stand against the IVDR, and what is time-critical.
Performance evaluation
Performance Evaluation Plan and PER under Art. 56 and Annex XIII, plus a study and PMPF plan where evidence gaps exist.
Technical documentation
Technical documentation under Annexes II and III, fully evidenced against the GSPR checklist of Annex I.
Notified body
Application submitted, signed written agreement, supported audit and structured resolution of the findings.
Certification & operation
CE marking under the IVDR, EUDAMED and UDI registration completed, PMS and vigilance system in operation.
Common pitfalls
Where projects commonly fail
The extended transition periods are assumed to apply automatically.
Regulation (EU) 2024/1860 ties them to conditions: a QMS under Art. 10(8) by 26 May 2025, a timely application to the notified body, and a signed written agreement. For class C, the application deadline expired on 26 May 2026, and the agreement must be in place by 26 September 2026.
A product change ends legacy status.
During the transition period, existing products may not undergo significant changes to design or intended purpose; a planned further development unintentionally forces the product into full IVDR compliance ahead of time.
Clinical performance is confused with analytical performance.
Annex XIII requires evidence for all three pillars of the performance evaluation; many manufacturers have robust analytical data but no clinical performance evidence. Literature alone rarely suffices, and proprietary performance studies need lead time for study planning and ethics approval.
PMS and vigilance are deferred to the period after certification.
Under Art. 110(3), the IVDR requirements for post-market surveillance, vigilance and registration already apply to legacy products; the gap surfaces at the latest during the notified body audit.
Classification is set too optimistically.
The rules in Annex VIII up-classify entire product groups, such as infectious disease diagnostics and companion diagnostics; a corrected class late in the project changes the conformity route, the deadline regime and the evidence requirements all at once.
FAQ
Frequently asked questions
Sources
- Regulation (EU) 2017/746 (IVDR), primary text, Art. 5, 10, 56, 78–82, 110, Annexes I, II, III, VIII, XIII
- Regulation (EU) 2022/112, amendment of the IVDR transitional provisions
- Regulation (EU) 2024/1860, staggered extension of the transition periods and EUDAMED rollout
- ISO 13485:2016, ISO 14971:2019, ISO 20916:2019
- Writer file: entourage-website-writer/output/expertise-pages/regulatory-compliance/ivdr-readiness/ivdr-readiness.md
- https://theentourage.de/expertise/ivdr-readiness/ (existing page content, revised)
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Related insights
All insights →Regulations & standards considered
- EU 2017/746 (IVDR)
- IVDR Annex I (General Safety and Performance Requirements, GSPR)
- IVDR Annex II/III (technical documentation)
- IVDR Annex VIII (classification rules, classes A–D)
- IVDR Annex XIII (performance evaluation & PMPF)
- IVDR Art. 5(5) (in-house IVDs in health institutions)
- IVDR Art. 10(8) (quality management system)
- IVDR Art. 56 (performance evaluation and clinical evidence)
- IVDR Art. 78–81 (post-market surveillance & PSUR)
- IVDR Art. 82 ff. (vigilance)
- IVDR Art. 110 (transitional provisions)
- Directive 98/79/EC (IVDD)
- EU 2022/112 (first amendment to the IVDR transitional provisions)
- EU 2024/1860 (staggered extension of the transition periods, EUDAMED rollout)
- ISO 13485:2016 (QM system)
- ISO 14971:2019 (risk management)
- ISO 20916:2019 (clinical performance studies for IVDs)
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