EU IVDR Compliance Software

The EU IVDR (Regulation 2017/746) replaced the In Vitro Diagnostic Directive (98/79/EC) and took effect on May 26, 2022. It represents a fundamental shift: the old IVDD allowed roughly 80% of IVDs to be self-certified by manufacturers, while the IVDR introduces a risk-based classification system (Classes A through D) that requires Notified Body involvement for most higher-risk devices for the first time. The regulation significantly raises the bar on clinical evidence (performance evaluation), technical documentation, post-market surveillance, and substance-related requirements. For substance compliance specifically, the IVDR mirrors the MDR’s approach under its General Safety and Performance Requirements - requiring identification and justification of CMR and endocrine-disrupting substances above 0.1% w/w in qualifying devices.

The transition is staggered by risk class, with key application and end-of-transition dates: • Class D (e.g., HIV, hepatitis tests): NB application by May 26, 2025; transition ends December 31, 2027. • Class C (e.g., certain cancer/influenza tests): NB application by May 26, 2026; transition ends December 31, 2028. • Class B and Class A sterile: NB application by May 26, 2027; transition ends December 31, 2029. • Class A non-sterile: No transition period - full IVDR compliance required since May 26, 2022. Within four months of each application deadline, a written agreement (contract) with the Notified Body must be concluded. These extensions apply only if the device hasn’t undergone significant design changes and the manufacturer has implemented an IVDR-compliant QMS and PMS/vigilance system.

Yes. Like the MDR, the IVDR’s General Safety and Performance Requirements (Annex I) include provisions on hazardous substances in devices. Manufacturers must identify CMR substances (Category 1A/1B under CLP) and endocrine-disrupting substances present above 0.1% w/w. For IVD devices that come into contact with the human body or handle body fluids/samples, the presence of these substances must be justified with a documented benefit-risk assessment, alternatives analysis, and - if the substance remains - appropriate labeling and instructions for use. The substance universe is governed by the same external lists (CLP Annex VI and REACH Candidate List) that apply to MDR, so the screening rules and supplier evidence requirements are substantively the same. If you’re already managing substance compliance for MDR devices, the IVDR framework will look very familiar.

The evidence requirements parallel the MDR. You need material declarations from suppliers confirming presence or absence of CMR 1A/1B and ED substances, lab test reports (chemical characterization per ISO 10993-18 where applicable), safety data sheets, and - where a substance exceeds 0.1% w/w in a qualifying device - documentation supporting the benefit-risk justification including an alternatives analysis. Each piece of evidence needs metadata: supplier name, date, version, expiry, and a clear link to the specific device or component. All of this feeds into your technical documentation and must be available for Notified Body review. Expired supplier declarations or untraceable evidence are common findings during NB audits - particularly for IVD manufacturers who previously self-certified under the IVDD and are now facing NB scrutiny for the first time.

Two compounding factors. First, under the IVDD, most IVDs were self-declared - manufacturers never needed a Notified Body. The IVDR’s new classification rules push the vast majority of Class B, C, and D devices into NB-assessed conformity procedures for the first time, meaning manufacturers must build technical documentation, clinical evidence (performance evaluation reports), and substance dossiers to a standard they may never have been held to before. Second, NB capacity is severely constrained - only about 19 Notified Bodies are currently designated for IVDR, creating bottlenecks for conformity assessments and long lead times for audit slots. The substance evidence piece is often one of the gaps that surfaces late in the process: manufacturers focused on clinical evidence and QMS readiness only to discover that their material composition data and supplier declarations don’t meet IVDR standards when the NB starts reviewing the technical file.

IVDR references both the CLP Regulation and REACH to define which substances require identification and justification. CMR 1A/1B substances are classified under CLP Annex VI (Part 3), and endocrine-disrupting substances are identified under REACH Article 59 (the Candidate List pathway). So the substance lists are shared - but the obligations differ. REACH requires supply chain communication of SVHCs above 0.1% w/w. IVDR goes further: for qualifying IVD devices, you must formally justify the presence of these substances with a benefit-risk assessment, evaluate alternatives, and label the device accordingly. RoHS, meanwhile, is a separate directive restricting specific substances in electrical and electronic equipment - IVD devices that contain electronic components may also fall under RoHS scope independently of IVDR. The practical takeaway: supplier data collected for REACH or RoHS is a useful starting point, but it needs enrichment (concentration data, alternatives analysis, justification narrative) to satisfy IVDR’s technical documentation requirements.