Test and Measurement: Regulatory Updates and Strategic Implications

Medical device companies are operating in a climate of rapid transformation. The traditional regulatory and testing frameworks that have guided development for decades are evolving, prompted by technological innovation, increased globalization, and lessons learned during recent public health challenges.

In 2024, regulators in the United States, Europe, and China have introduced sweeping changes in areas ranging from quality management and biocompatibility to sterilization and diagnostics oversight. At the same time, digital transformation is redefining how companies approach quality assurance, compliance, and testing workflows.

These shifts aren’t just bureaucratic adjustments. They reflect a deeper emphasis on patient safety, product transparency, and global alignment. To thrive in this environment, device developers and manufacturers must take a proactive approach: understanding not only the new requirements but also how to integrate them efficiently and strategically into their operations.

This article explores the six most important areas shaping the current regulatory and testing landscape and what they mean for medical device innovators navigating this new terrain.

FDA’s QMSR Rule: Closing the Gap Between U.S. and Global Quality Systems

The most headline-making update in 2024 came in the form of the FDA’s Quality Management System Regulation (QMSR) final rule. This amendment replaces the current 21 CFR Part 820 with a quality framework aligned with ISO 13485:2016, the globally recognized standard for medical device quality systems.

The new rule introduces a phased implementation timeline.

This amendment is intended to reduce regulatory burdens on device manufacturers and facilitate a globally harmonized approach to quality management systems. ¹

This is a landmark shift. For years, manufacturers selling both domestically and internationally had to juggle two parallel systems. Now, the FDA is joining regulators in Europe, Canada, and else-where in recognizing ISO 13485 as the baseline for quality management. Key implications:

ISO-aligned risk management: Organizations will need to embrace ISO 14971-driven risk management approaches, integrating them across design, manufacturing, and postmarket surveillance.
Supplier and purchasing controls: ISO 13485 places heavier emphasis on supplier qualification and purchasing record documentation, which may exceed legacy FDA expectations.
Training and readiness: Quality, regulatory, and operations staff must be trained not just in compliance but also in how ISO frameworks influence design and validation decisions.

FDA advises that “manufacturers should conduct gap assessments now and prioritize training across quality and regulatory teams to ensure smooth implementation.” ¹

Table 1. Comparison of 21 CFR 820 and ISO 13485:2016

Companies already certified to ISO 13485 will have a head start but should not assume automatic compliance. FDA inspections will still emphasize specific U.S. requirements, especially regarding complaint handling and records management (see Table 1).

ISO 18562: Devices with Breathing Gas Pathways

Biocompatibility is foundational to medical device safety but not all standards are created equal. While ISO 10993 remains the core framework for most devices, it doesn’t fully address those with breathing gas pathways such as ventilators, anesthesia systems, nebulizers, and CPAP machines.

ISO 18562, which focuses specifically on the emissions from devices that interact with a patient’s respiratory system, addresses this aspect. The 2024 update to ISO 18562 offers a refined approach to evaluating volatile organic compounds (VOCs), particulates, and leachables that patients could inhale during use.

“The 2024 update fills critical gaps not covered by ISO 10993 and provides improved risk models tailored to respiratory exposure,” according to NAMSA. ² Key updates include:

Enhanced test methods for detecting VOCs and particulates under simulated use conditions.
New risk models based on total daily inhaled dose and patient exposure time frames.
Broader harmonization with ISO 10993-1 risk assessment principles.

Regulatory agencies are increasingly calling for ISO 18562 testing as part of standard premarket submissions, particularly for devices cleared under FDA’s 510(k) or EU MDR pathways.

“Start upstream. Early partnership with labs that have inhalation biocompatibility expertise can save months of rework,” advises Nelson Labs. ³ Designers should plan for ISO 18562 evaluations early in the development process. Waiting until later stages often results in reengineering, especially if unexpected emissions are detected.

Moist Heat Sterilization: ISO 17665:2024 Recognized by FDA

Sterilization continues to be a critical focus in regulatory reviews. This year, FDA added the newly updated ISO 17665:2024 standard for moist heat sterilization to its list of recognized consensus standards.

Autoclaving remains one of the most widely used sterilization methods for reusable and single-use medical devices. The updated standard tightens controls on process validation and routine monitoring to reduce the risk of sterilization failure. “Recognition of ISO 17665:2024 underscores FDA’s continued effort to modernize sterilization validation protocols.” ⁴ Notable enhancements include:

Stronger guidance on steam penetration testing and biological indicator (BI) placement.
Refined cycle development parameters tailored to different device configurations and materials.
Expanded sustainability considerations, encouraging manufacturers to optimize energy and water usage.

Companies should review current moist heat processes for compliance with revised performance qualification expectations. It is important to update sterilization validation protocols, and ensure staff are trained on new documentation requirements. Finally, OEMs need to requalify older devices to confirm continued compliance with the new standard, especially if submitted for reclearance or EU recertification. These updates are especially critical for contract sterilization providers, who must now align internal procedures with both updated ISO standards and increasingly rigorous customer audits.

FDA Final Rule: LDTs Regulated as Medical Devices

In a move long debated in the diagnostics world, FDA finalized its rule to regulate laboratory-developed tests (LDTs) as full-fledged in vitro diagnostic (IVD) devices in May 2024. Historically, LDTs have operated in a regulatory gray zone, often developed and validated within a single lab without FDA clearance. But as LDTs have become more complex — and more essential to clinical decision-making — FDA is taking steps to ensure consistency and reliability.

According to FDA, this policy shift reflects the increasing complexity and clinical impact of LDTs (see the sidebar, “LDT Implementation Timeline.”) This creates a significant operational and regulatory shift for clinical laboratories that must now implement formal quality management systems, align with FDA validation requirements, and prepare for federal inspections. The rule was spurred by several “public safety incidents involving LDTs lacking analytical validation,” especially during the COVID-19 pandemic. ⁵

For test developers and reference labs, the message is clear: build compliance into your product road map. Collaboration with regulatory consultants, test method validation partners, and IVD-experienced legal counsel will be crucial for a smooth transition.

Global Developments: China and the EU Refine Regulatory Models

Regulatory change isn’t limited to the United States. In 2024, both China and the European Union are implementing major updates aimed at balancing innovation with safety. In China, the National Medical Products Administration (NMPA) has introduced or updated 139 technical standards in 2024 alone as part of a broader effort to harmonize with international guidelines while preserving local oversight. According to China Med Device, “These changes align China’s device approval process more closely with international practices.” ⁶

Key features include increased reliance on type testing at accredited domestic labs, mandatory clinical evaluation reports (CERs) for Class II and III devices, and more stringent postmarket surveillance and adverse event reporting obligations. Foreign manufacturers must also consider that imported products often require duplicate testing in China, regardless of prior international validation.

In response to concerns over device shortages and regulatory bottlenecks, the EU has extended MDR and IVDR transition deadlines. But this temporary relief comes with a renewed focus on supply chain transparency, UDI implementation, and EUDAMED database participation. Manufacturers must continue aligning technical documentation, clinical evidence, and postmarket vigilance systems with the new regulations, regardless of extended deadlines.

Digital Transformation in Testing and Quality Systems

As regulatory frameworks become more sophisticated, device companies are increasingly adopting digital tools to manage testing data, track performance, and demonstrate compliance.

“Digital transformation in testing enables proactive quality assurance and facilitates regulatory transparency,” notes the Medical Device Innovation Consortium. ⁷ Digital testing trends gaining momentum include cloud-based QMS platforms with audit-ready traceability, AI-powered analytics that identify trends in stability testing or detect drift in raw material specs, and blockchain-backed lab records, offering tamper-proof audit trails and real-time verification of test results. The benefits are faster root-cause investigations, streamlined audits, and improved cross-functional collaboration. However, digital adoption brings its own challenges.

The FDA’s 2023 guidance on cybersecurity urges compliance with NIST 800-53 standards, especially when using connected test equipment or cloud-based systems. ⁸ Device manufacturers should prioritize cybersecurity risk assessments, data integrity validation, and IT infrastructure audits to ensure digital tools enhance rather than compromise—compliance.

Conclusion

The regulatory and testing landscape for medical devices is shifting in real time. Standards are being revised. By embracing standards like ISO 13485, ISO 18562, and ISO 17665, preparing for the FDA’s regulation of LDTs, and adopting smarter, connected testing environments, manufacturers can build more agile, robust, and globally competitive operations.

The devices of the future—more complex, personalized, and connected than ever — demand equally sophisticated approaches to quality and compliance.

This article was compiled by Medical Design Briefs.