In-Vitro Diagnostics (IVD) | MedTech Compliance Guide

EU requirements

Classification: IVDR Annex VIII Rules 1–7 classify IVDs from A (lowest risk) to D (highest risk). Examples include transmissible-agent and transfusion tests in D, many STI, cancer, genetic, and companion diagnostics in C, and general laboratory reagents or instruments in A.
Conformity pathway: Under Article 48, Class A is generally self-declared (sterile A has limited Notified Body involvement); B uses Annex IX Chapter I and III with sampling; C uses Annex IX or Annex X plus XI; D requires full Annex IX including EU Reference Laboratory verification and expert-panel involvement.

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01Classify the device under IVDR Annex VIII Rules 1–7.Source: IVDR Annex VIII
02Determine self-testing, near-patient, and companion-diagnostic status.
03Select the conformity assessment route under Article 48.Source: IVDR Article 48
04Compile a Performance Evaluation Report.
05For Class D, prepare for EU Reference Laboratory verification and expert-panel review.Source: IVDR Article 48
06Establish a PMS plan and assign a Basic UDI-DI.

Classification: IVDs are Class I, II, or III under 21 CFR Parts 862, 864, and 866.
Conformity pathway: Moderate-risk IVDs with predicates typically use 510(k); high-risk products such as certain blood-screening and companion diagnostics use PMA. CLIA categorization applies in parallel.

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01Confirm the classification, applicable 21 CFR Part 862, 864, or 866 regulation, and product code.Source: FDA IVD Regulation Overview
02Determine the CLIA complexity category.Source: FDA CLIA Categorizations
03Select the 510(k), De Novo, or PMA pathway.Source: FDA IVD Regulation Overview
04Generate analytical and clinical validation data.
05Prepare labeling under 21 CFR 809.10.
06Establish a QMSR and ISO 13485-aligned quality system with a DHF.Source: FDA QMSR