In Vitro Diagnostic (IVD) Medical Device Testing & Certification

Expert Testing and Compliance Solutions for IVD Medical Devices

In vitro diagnostic (IVD) medical devices are essential to modern healthcare, supporting early detection, monitoring, and disease management. As technologies evolve, from molecular diagnostics and next-generation analyzers to digitally connected and AI-enabled systems, manufacturers face increasingly complex regulatory expectations. Meeting global requirements for safety, accuracy, and performance is critical to launching reliable IVD devices in critical clinical settings.

Intertek provides comprehensive testing, certification, and regulatory guidance throughout the product lifecycle. Our teams help manufacturers interpret evolving global regulations including the EU IVDR, FDA pathways, Health Canada requirements, and multi-country market access programs, and we deliver the evidence needed to demonstrate compliance with confidence.

Why IVD Manufacturers Choose Intertek

IVD devices must meet rigorous expectations for safety, cybersecurity, automation reliability, and connectivity to laboratory information systems. Intertek brings together deep technical expertise across electrical safety, software, usability, EMC, cybersecurity, and performance evaluation. We assess IVD equipment to key international standards such as IEC 61010-1 and IEC 61010-2-101, ISO 14971, ISO 13485, IEC 61326-2-6, IEC 60601-1-2, IEC 62304, and IEC 62366-1, while also evaluating biological, microbiological, and sterilization-related performance.

Whether verifying reagent accuracy, assessing software and cybersecurity, or evaluating self-testing devices used in home settings, Intertek provides integrated, end-to-end solutions. Our global network of more than 1,000 laboratories ensures fast project execution supported by decades of experience in IVD innovation.

Global Regulatory Expertise for IVD Devices

• EU In Vitro Diagnostic Regulation (IVDR 2017/746)
  The EU IVDR dramatically increases expectations for clinical evidence, documentation, and post-market surveillance. Intertek helps manufacturers prepare complete technical files, validate analytical and performance claims, confirm device classification, and navigate interactions with Notified Bodies. Because harmonized standards under the IVDR continue to evolve, we help determine which international or state-of-the-art standards are most appropriate when clear guidance is not yet finalized.

• FDA Requirements for IVD Devices
  IVD products entering the U.S. market must adhere to FDA’s Quality System Regulation and follow the appropriate submission pathway, whether 510(k), De Novo, or PMA. Intertek supports device safety evaluations, EMC testing to IEC 60601-1-2 (as required by FDA), performance verification, labeling requirements, and CLIA considerations. Our test reports are widely recognized for supporting FDA submissions and global regulatory filings.

• Global Market Access (GMA)
  Beyond the U.S. and EU, IVD manufacturers must navigate requirements across APAC markets (including China NMPA and Japan PMD Act), Canada’s IVDD/IVDR system, Latin America, the Middle East, and more. Intertek’s Global Market Access program delivers a single roadmap that simplifies multi-country approvals. Through the IECEE CB Scheme, including the IEC 61010-2-101 pathway, we help streamline certifications across regions and reduce time-to-market.

IVD Medical Equipment Safety & Performance Testing

• IEC 61010-2-101 Compliance
  IEC 61010-2-101 is the particular standard specifically written for in vitro diagnostic (IVD) medical equipment. It is used in conjunction with the main IEC 61010-1 standard, which defines the general safety requirements for laboratory, measurement, and control equipment. In practice, manufacturers must comply with both: IEC 61010-1 establishes the foundational safety criteria, while IEC 61010-2-101 adds IVD-specific provisions addressing hazards unique to diagnostic environments.
  
  The particular standard supplements or replaces portions of IEC 61010-1 where additional protections are needed, for example, labeling requirements for biohazardous materials, design expectations for interlocks and containment systems, and risk controls related to chemicals, aerosols, flammable liquids, and radiation. Together, the two standards ensure that IVD analyzers, automated instruments, and self-test devices provide adequate protection for users, patients, and laboratory personnel.
  
  Intertek evaluates IVD equipment against both IEC 61010-1 and IEC 61010-2-101, performing electrical and mechanical safety assessments, verifying markings and instructions, analyzing functional safety performance, and assessing risks associated with biological and chemical exposure. Our laboratories are accredited to the latest editions of both standards and can issue CB Scheme reports to support fast, streamlined approvals in global markets.

• Electromagnetic Compatibility (EMC) Testing
  IVD devices must operate reliably in busy laboratory environments where electrical interference is common. Intertek performs full EMC evaluations to IEC 61326-2-6 and IEC 60601-1-2, including the higher immunity levels often required for FDA submissions. Pre-compliance screening helps address issues early, minimizing redesign and shortening timelines.

• Software, Cybersecurity & Connectivity
  Modern IVD products increasingly rely on embedded software, mobile applications, LIS connectivity, AI-driven decision support, and cloud-based data management. Intertek assesses software lifecycle compliance (IEC 62304), usability engineering (IEC 62366-1), and cybersecurity controls, while also examining data integrity, access management, and algorithmic performance risks. Our teams help manufacturers demonstrate digital health readiness for regulators and customers.

Intertek Services for IVD Manufacturers

• Early-Stage Design Support
  Intertek works with engineering and regulatory teams during early development to identify compliance gaps, clarify standard applicability, and reduce downstream delays. Services include Preliminary Design Reviews, risk and usability evaluations, and early alignment with IVDR, FDA, and IEC 61010 expectations.

• Comprehensive Laboratory Testing
  Our laboratories conduct electrical safety, EMC, mechanical, chemical, and biological evaluations, along with reagent performance assessments, environmental and reliability testing, and full software and cybersecurity verification. This holistic approach ensures that every aspect of your device meets regulatory and operational expectations before submission.

• Certification & Market Access
  Intertek offers ETL Certification for IVD equipment, CB Scheme certification to IEC 61010-2-101, ISO 13485 quality management audits, and a complete suite of test reports recognized worldwide. Ongoing compliance programs support product families, refreshed models, and incremental design updates, helping maintain compliance throughout the lifecycle.
  
  Intertek combines deep technical knowledge, global market understanding, and flexible engagement models, from data acceptance programs to on-site evaluations, to give manufacturers a clear path to approval and long-term regulatory readiness.

Why Intertek Is the Trusted Partner for IVD Testing

Intertek brings together a global network of advanced laboratories, cross-disciplinary engineering and scientific expertise, and decades of experience supporting medical technology innovation. Our teams help manufacturers reduce risk, accelerate development, and advance diagnostic products into global markets efficiently and responsibly.

With a Total Quality Assurance approach, we support everything from design and production to launch and post-market monitoring to ensure the ongoing safety, quality, and performance of your IVD devices.