September 25, 2025

The Changing World of IVD Devices

In vitro diagnostic (IVD) devices are growing fast in healthcare. From COVID-19 test kits to home-use diagnostic apps, people now expect quick, safe, and connected ways to check their health.

However, as IVD technology gets smarter with AI, robotics, and IoT, the rules to keep devices safe and compliant are also getting tougher. Companies must follow strict FDA rules in the US, IVDR regulations in Europe, and global safety standards to sell their products.

At Maven Regulatory Solutions, we help IVD manufacturers stay compliant, safe, and market-ready with expert support on IVDR compliance, FDA approvals, CE marking, risk management, and labeling.

Why IVD Devices Are Growing

  • Post-pandemic demand: COVID-19 showed the need for fast, reliable tests.
  • Point-of-care testing: Simple home-use devices are now common.
  • Connected devices: Users want health data linked to apps and devices.
  • Lab automation: Robots and analyzers process samples faster but add new risks.

This growth creates opportunity—but also more compliance challenges for manufacturers.

The Compliance Challenge

Different countries have different IVD regulations:

  • FDA (US): Requires clearance or approval based on safety and performance.
  • IVDR (EU): Strict new rules for CE marking and market access.
  • Global markets: Expect alignment with “state-of-the-art” standards.

Key question: Who will use the device?

  • Professionals in labs → must meet performance and safety standards.
  • Everyday users at home → must meet extra rules for usability and safety.

Devices with lasers, heating parts, centrifuges, or robotics may also need to follow special IEC safety standards like:

  • IEC 61010-2-101 (IVD safety)
  • IEC 60825 (laser safety)
  • IEC 61508 / ISO 13849 (robotics safety)

Design and Safety Considerations

When creating IVD devices, manufacturers must plan for risks like:

  • Biohazards from samples
  • Harmful chemicals or flammable substances
  • Usability for non-professionals

IEC 61010-2-101 gives safety guidance on:

  • Clear labels and warnings (biohazard symbols, safety signs)
  • Easy-to-follow manuals for safe use and maintenance
  • Built-in protections like interlocks and temperature controls

Some devices may also need to follow extra standards if they use heating or centrifuges.

Risk Management and Documentation

To get FDA clearance or CE mark under IVDR, companies must create a strong risk management file.

This file should:

  • List all possible risks
  • Show how risks are reduced or controlled
  • Prove with testing and validation that the device is safe

Regulators and testing labs check these documents carefully before approval.

Why Early Planning Matters

IVD compliance is not something to leave until the end. Planning early helps:

  • Define target markets (EU, US, global)
  • Map out the right standards and regulations
  • Avoid delays and recalls
  • Launch products faster with CE mark or FDA approval

How Maven Regulatory Solutions Helps

At Maven Regulatory Solutions, we make IVD compliance simple. Our services include:

  • IVDR & FDA Guidance – Get clear steps for EU, US, and global approvals
  • Risk Management Support – Build complete risk files for regulators
  • IVD Labeling & IFU Compliance – Ensure clear, correct product labels and instructions
  • Global Standards Expertise – IEC 61010, IEC 60825, ISO 13485, and more
  • Market Access Strategy – CE marking, FDA clearance, worldwide registrations
  • Testing & Certification Support – Navigate lab testing and performance checks

With Maven, you can launch your IVD devices faster, safer, and with full compliance.

Conclusion

The world of IVD device compliance is changing quickly. Manufacturers must meet new rules like IVDR in Europe, FDA requirements in the US, and IEC safety standards worldwide. With early planning, strong documentation, and the right partner, companies can avoid risks, reduce costs, and enter markets with confidence.

???? At Maven Regulatory Solutions, we help diagnostic device companies stay compliant, get approvals, and grow globally.