Streamlining Medical Device Quality Compliance: The Transition from FDA QSR to QMSR

The U.S. Food and Drug Administration (FDA) have issued their final rule amending the Quality System Regulation (QSR) to better align with ISO 13485:2016, the international standard for quality management systems for medical devices. Therefore, the transition from the current Quality System Regulation (QSR, 21 CFR Part 820) to a new Quality Management System Regulation (QMSR) has commenced. This transition is aimed at aligning U.S. regulations more closely with the international standard, streamlining compliance for medical device manufacturers and enhancing global regulatory harmonisation.

1. Rationale for the Change

Historically, the FDA’s mission has centered on ensuring the safety and efficacy of medical devices for patients and users. The move to QMSR reflects an alignment with this mission while addressing the inefficiencies of dual compliance burdens faced by manufacturers with both QSR and ISO 13485. 

The last major update to QSR was in 1996, and since then, ISO 13485 has undergone several revisions, with its 2016 version closely mirroring the FDA’s requirements. This harmonisation is a strategic step towards simplifying regulatory compliance without compromising on safety standards.

2. Key Updates and Compliance Strategies

A number of key changes should be understood by medical device manufacturers as they prepare to transition to the new rules. These include 

  • Terminology and Definitions: The QMSR adopts ISO 13485:2016’s terminology, streamlining communication and documentation processes for manufacturers. This includes updating definitions for terms like device master record (DMR), device history record (DHR), and design history file (DHF), aligning them with international practices.
  • Enhanced Records Control: The QMSR incorporates ISO 13485’s records management requirements, with additional provisions for document confidentiality and regulatory compliance. This ensures that manufacturers maintain rigorous control over quality documentation, enhancing traceability and accountability.
  • Labelling and Packaging Oversight: Despite the harmonisation, the FDA has chosen to retain specific labelling and packaging requirements from the current QSR, citing the need for superior practices in these areas. Manufacturers must navigate these requirements, ensuring that their products meet both ISO 13485 and QMSR standards.
  • Focus on Risk Management: The QMSR emphasises risk management throughout the product lifecycle, reflecting ISO 13485’s approach. This shift requires manufacturers to integrate risk management practices more comprehensively the previously, moving beyond the limited scope previously outlined in the QSR.
3. ISO 13485 Certification: Not Mandatory, but Beneficial

Manufacturers are not required to obtain ISO 13485 certification to comply with the QMSR for the U.S. market. However, for broader market access, including in the UK, Canada, Europe, and Australia, ISO 13485 certification becomes a strategic asset, facilitating smoother entry into these highly regulated markets.

4. Implementation Timeline and Preparation

The FDA has set the effective enforcement date for the QMSR as February 2, 2026. This timeline provides manufacturers with a window to prepare, advising against a wait-and-see approach. Proactive alignment with ISO 13485:2016, through detailed gap analyses and QMS adjustments, is recommended to ensure compliance by the enforcement date.

5. How Deviceology Ltd Can Help

At Deviceology, we specialise in navigating the complexities of medical device regulatory compliance. Our expertise in both FDA regulations and ISO standards positions us to support manufacturers through this transition. Here’s how we can assist:

  • Gap Analysis Services: Our gap analysis identifies specific areas of your QMS that require adjustments to meet QMSR and ISO 13485:2016 standards, providing clear guidance for compliance.
  • Customised Compliance Strategies: We develop your transition plan that address your organisational and product requirements, supporting a smooth transition to QMSR compliance while optimising operational efficiency and minimising disruption to ongoing procedures. 
  • Regulatory Support and Documentation: Our team assists in updating terminology, records management practices, and risk management processes to align with the new regulations, streamlining documentation and ensuring audit readiness.
  • Training and Education: Deviceology offers targeted training sessions for your team, ensuring a thorough understanding of the changes and how they impact your operations.

As the QMSR implementation date approaches, partnering with Deviceology can provide the expertise and support necessary to navigate this regulatory shift confidently. Our goal is to provide the support and guidance you need so your transition efforts are both efficient and effective, paving the way for continued success in the U.S. and global markets.

Get in touch today to see how we can help!