AMDM 2025: Shaping the Future of IVD Regulation

From MDUFA to EUDAMED—What Regulatory Leaders Need to Know

The 2025 AMDM Annual In Vitro Diagnostics (IVD) Regulatory Meeting delivered two full days of deep insight, lively discussion, and policy-shaping perspectives across the global diagnostics landscape. Despite the absence of several EU-based presenters due to a travel strike in Belgium and limited engagement from current FDA officials, the sessions offered clarity on pressing regulatory developments and emerging industry priorities.

Day 1: U.S. Landscape, Enforcement, Quality Systems, and Innovation

US FDA Landscape & Policy Direction

• Even with significant disruptions—nearly 3,500 staff impacted by reductions in force and continued institutional knowledge loss through retirements—OHT7 remains committed to meeting MDUFA timelines. However, behind that resilience, growing concerns have emerged around internal restrictions on transparency and open scientific exchange.

QMSR Final Rule

• FDA’s alignment of 21 CFR Part 820 with ISO 13485 through the QMSR final rule is moving ahead as planned, with no indication of delay.
• With a compliance deadline of February 2026, organizations should be actively conducting gap assessments now—particularly around risk management integration, removal of inspection exceptions, training systems, supplier controls, and the management of activities to ensure integrity, inspection, storage, and operations for labeling and packaging.
• Early remediation will position companies for smoother transitions during inspections and audits.- Cybersecurity and Software Requirements.

Software, Cybersecurity & AI/ML IVDs

• Although digital health tools, software as a medical device (SaMDs), and AI/ML-enabled diagnostics are becoming more prevalent, sponsors continue to face challenges meeting the Agency’s expectations.  Cybersecurity remains a leading cause of submission refusals and delays with gaps in threat modeling, software bill of materials (SBOM) documentation, and lifecycle security plans persisting. 
• Successful development and deployment of AI/ML IVDs rely on implementation of robust design control frameworks and risk management principles, including defined risk-mitigation and post-market monitoring strategies to minimize algorithm bias.  Independent data sets for development and test, ideally on study cohort level is one method for minimizing bias and for ensuring reproducible analytical and clinical device performance.

LDT Rule Vacated

• The recent federal court ruling vacating FDA’s final LDT rule has removed near-term compliance obligations but introduced long-term uncertainty.
• While the Court determined regulation of LDTs falls under CMS and CLIA oversight, this is not a return to status quo.
• Questions remain—especially for CDx and single-site tests developed within precision medicine programs. For example, CDER and CBER may still request validation data and rely on CDRH consultation. Early engagement with drug and biologic review divisions is prudent.
• The government may repeal the court decision, but must do so by end of May 2025.

Day 2: Global Regulatory Strategy and Market Opportunities

European Union: IVDR, AI Act, and EUDAMED IVDR Transition

• The phased IVDR transition continues through 2029, but enforcement is already in motion.
• Audits are uncovering deficiencies in compliance with Article 10a—specifically in continuity of supply planning and communication protocols.
• Additional deficiencies should be anticipated if sponsors with legacy devices do not comply with the requirements of Article 10 by the end of May.

EUDAMED Rollout

• Modules for actor registration, UDI, and device listings are set to become mandatory by January 2026. Manufacturers should use the current “playground” environment to test readiness and avoid future data bottlenecks.

AI Act Integration

• High-risk AI systems will face conformity assessments embedded within MDR/IVDR processes. Notified Bodies will need specialized AI evaluation competencies.

New UK Regulations

• While Great Britian’s MDR and EU’s IVDR share many features, their divergence has important implications for global regulatory planning.
• The new post-market surveillance (PMS) regulation (effective June 16, 2025) mirrors many IVDR concepts but adds enhanced expectations around user experience and field safety corrective action notifications.  Currently there is no guidance as to whether UKCA-marked companion diagnostics being used in a clinical trial of an investigational medicinal product are expected to apply with PMS requirements due to their UKCA marking.
• The proposed UKCA premarket framework introduces international reliance mechanisms—such as recognition of CE-marked products and approvals from select peer regulators—but not all CDx or SaMDs are expected to be eligible.
• Additional statuary instruments (SIs) are expected in 2025.
  

Asia-Pacific Region: Acceleration and Modernization

• Across the Asia-Pacific region, significant regulatory modernization is underway
• Japan: Regulatory processes remain rigorous but stable, with CDx demand increasing. Reference pricing reforms are reshaping market access.
• Korea: registration is more difficult than before, however the newly-introduced Immediate Market Entry policy aims to reduce review timelines for cutting edge technologies to under 140 days.. Korea is also developing the first generative AI device review guideline.
• Singapore: released a draft document for IVD medical devices in May 2023, expanding the risk classification to include derivatives of blood, organs, or cell tissues, ensuring to ensure a broader spectrum of IVD devices is adequately regulated.
• China: Continued prioritization of in-country clinical trials, local manufacturing and cost-containment through national volume-based procurement schemes. 
•  India & Southeast Asia: India’s new classification and adverse event systems aim to harmonize regulatory control.

These developments signal growing regional harmonization with global norms—but each market still requires careful navigation and local expertise.

CDx, Rare Biomarkers, and Sample Scarcity

• Competition for retained sample use among clinical trial enrollment, patient care, scientific research, and CDx development, remains a challenge in precision medicine, particularly in rare disease. 
• Real-world data, in silico modeling, contrived samples, and bridging studies are viable when scientifically justified.
• Regulatory flexibility is possible, but only when supported by rigorous rationale and transparent engagement with FDA.

Final Reflections

Across both days, one key message emerged: regulatory harmonization may remain aspirational, but strategic alignment is achievable. The IVD Regulatory Update 2025 reinforced that sponsors must remain agile in response to regulatory change, especially as the FDA, EU, and other regions strengthen expectations around digital health, cybersecurity, and real-world evidence.

Success in 2025 and beyond will depend on a sponsor’s ability to anticipate regulatory expectations, plan with agility, and maintain open, evidence-based communication with health authorities. The IVD Regulatory Update 2025 made it clear that staying ahead requires not only technical excellence but also regulatory intelligence.

To explore how these evolving regulatory developments may affect your organization—and how we can support your IVD product strategy through this period of global change—please get in touch.

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