As the medical device industry moves into 2025, manufacturers must stay ahead of the latest regulatory changes. The FDA and EU are implementing several significant updates that will impact various aspects of device development, approval, and post-market surveillance. These changes are designed to improve patient safety, ensure the effectiveness of devices, and align U.S. standards with international regulations. For medical device manufacturers, staying on top of these regulatory shifts is critical to avoid delays, costly fines, and disruptions in market access. Here's a rundown of the top five FDA and EU regulations that you need to know, as they will shape the landscape for medical devices in the coming years.
1) AI-Enabled Device Guidance – The FDA’s guidance for artificial intelligence (AI) and software as a medical device (SaMD) is expected to be fully implemented in 2025. Manufacturers of AI-driven medical devices will need to adhere to new post-market surveillance and risk management practices. As stated in the guidance, released on January 6, 2025, the FDA will require clear documentation of algorithmic decision-making processes, and manufacturers will need to establish mechanisms for continuous monitoring of device performance and data integrity. This regulation also emphasizes transparency in the functionality of AI algorithms and their validation, which will be crucial for gaining and maintaining market approval.
2) Transition to QMSR – February 2, 2026 – The FDA will implement the Quality Management System Regulation (QMSR), which aligns with ISO 13485:2016. This updated regulation will require medical device manufacturers to transition from the existing Quality System Regulation (QSR) to a more globally harmonized system. Manufacturers will need to ensure their internal processes, documentation, and product lifecycle management are in compliance with these new standards. The move to QMSR represents a significant shift toward improving the consistency, safety, and effectiveness of medical devices, with a focus on robust quality management practices throughout the product lifecycle.
3) Medical Device User Fees – The FDA has announced the Medical Device User Fee rates for fiscal year 2025, which will be effective from October 1, 2024, through September 30, 2025. This will affect medical device manufacturers' costs for establishment registration, product listing, and submission of premarket notifications. The updated fee structure is designed to ensure the FDA can continue to meet its regulatory and oversight responsibilities. Manufacturers need to review and plan for these new fees to avoid delays in device approvals or registration processes. These fees can be substantial, so staying informed will ensure manufacturers' devices meet regulatory timelines without unexpected costs. Learn more below.
4) FDA Rule on Lab Developed Tests (LDTs) – Full implementation of the FDA’s regulations for laboratory-developed tests (LDTs) is set to occur in 2025. Under these new rules, LDTs will be subject to the same regulatory requirements as in vitro diagnostic devices (IVDs), including premarket review, post-market surveillance, and reporting of adverse events. Laboratories will be required to comply with Good Manufacturing Practices (GMP), submit premarket notification or approval applications, and follow stringent labeling guidelines. This regulation aims to ensure that LDTs meet the same safety, effectiveness, and quality standards as other diagnostic devices in the market.
5) EU IVDR and MDR Extension – In 2025, medical device manufacturers will need to be particularly focused on the EU In Vitro Diagnostic Regulation (IVDR) and the EU Medical Device Regulation (MDR) extensions, both of which are critical for compliance in the European Union.
- EU IVDR: Full compliance for In Vitro Diagnostic (IVD) manufacturers will be due by May 26, 2025. This regulation has significantly impacted manufacturers, especially since many IVD producers lacked experience with notified bodies under previous legislation. Now, with the shift to ISO 13485 for Quality Management Systems (QMS) and the need for third-party review, it’s imperative that manufacturers have their QMS in place. Any delays in documentation or submission to the notified bodies could lead to significant bottlenecks as the deadline approaches.
- EU MDR: For medical devices, the original EU MDR compliance deadline was May 2020, but extensions were granted due to the pandemic and issues with notified bodies. Now, May 2024 marked the end of the transitional period, and manufacturers must comply with these new, stricter regulations or risk losing access to the European market. With longer review times expected at notified bodies, manufacturers should submit their technical documentation well in advance to avoid disruptions to sales.
These upcoming regulations behooves proactive attention and preparation from manufacturers to ensure timely compliance, especially given the capacity constraints at notified bodies and the complex nature of the new rules.
As these regulatory changes take effect, it’s essential for medical device manufacturers to stay informed and prepared. Navigating these updates can be complex, but with the right guidance, you can ensure compliance and streamline your path to market.
At MEDIcept, we specialize in regulatory affairs, quality, clinical, compliance and reimbursement services, helping companies like yours stay ahead of industry shifts.
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References
- “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing.” FDA, U.S. Food and Drug Administration, www.fda.gov/regulatory-information/search-fda-guidance-documents/artificial-intelligence-enabled-device-software-functions-lifecycle-management-and-marketing.
- “Medical Devices; Quality System Regulation Amendments.” Federal Register, 2 Feb. 2024, www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments.
- “Medical Device User Fee Rates for Fiscal Year 2025.” Federal Register, 31 July 2024, www.federalregister.gov/documents/2024/07/31/2024-16883/medical-device-user-fee-rates-for-fiscal-year-2025.
- “Medical Devices; Laboratory-Developed Tests.” Federal Register, 6 May 2024, www.federalregister.gov/documents/2024/05/06/2024-08935/medical-devices-laboratory-developed-tests.
- “Regulation (EU) 2017/746 of the European Parliament and of the Council on In Vitro Diagnostic Devices.” EUR-Lex, 9 July 2024, eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02017R0746-20240709.
- “Regulation (EU) 2017/745 of the European Parliament and of the Council on Medical Devices.” EUR-Lex, eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745.
Ava Carr – Content Creator
Melissa Paffenroth – Senior Consultant, Regulatory