First introduced by the FDA in 2000, ISO 14971:2000 set forth the industry compliance standard by which medical device manufacturers (“MDMs”) would approach risk management of medical devices. The standard offered MDMs a strategy and processes by which to address potential risks MDMs could encounter in the manufacturing process, along with formal terminology to establish unified interpretation of the standard.
In the most recent update (ISO 14971:2019) the FDA expands the scope of medical device risk management. It extends the mandate for MDMs to address potential medical device risks that may present during its life cycle, adding data-driven post-market monitoring, for a full-circle loop. In short, where some standards address only the greatest risks, ISO 14971:2019 broadens the scope to manage all hazards, including “biocompatibility, data and systems security, electricity, moving parts, radiation and usability.”
The significance of ISO 14971:2019 to industry and its contributing partners is multifaceted. First, it gives MDMs a well-defined structure to follow in implementing the standard. Second, its comprehensive framework provides a clear path for MDMs to impact medical device safety and patient safety. The document also heightened focus on benefit-risk ratios.
In Europe, the US ISO 14971 is followed as EN ISO 14971. They are identical in language regarding hazards, risks, evaluation and control. Both set forth the same global standard for risk management of medical devices. The harmonized European standard is EN ISO 14971:2019+A11:2021. The amendment sets forth which clauses of the full document align with which articles of the EU MDR and its separate In Vitro Diagnostic Regulation.
How ISO 14971:2019 Works
To meet its objectives, ISO 14971:2019 guidance integrates data collection, QMS and risk management in a proactive framework. Previously, marketplace complaints submitted to the FDA served as the primary means of prompting investigation. The normative content of ISO 14971:2019 places the onus on medical device makers to overhaul their QMSs, and to identify, document and assess hazards using empirical data, ultimately creating a “closed loop” of data monitoring.
The standard also names risk categories that have become more prevalent in medical devices, with the emergence of In Vitro Diagnostics, electromagnetics, and potential biocompatibility hazards, to name a few. In addition to the expanded post-production actions, ISO 14971 strikes a new direction by calling on manufacturers to create objective criteria for risk tolerance without setting a one-size-fits-all, subjective benchmark. Instead, it recognizes the one-of-a-kind parameters of every medical device to complete the due diligence that results in accurate reporting and implementation of the standard for every device.
The Nexus between ISO 14971 with ISO 11607-1 and ISO 11607-2
The ISO 11607-1 and 11607-2 standards are the well-known foundation of sterile barrier systems for packaging of US medical devices. Where ISO 14971 establishes principles, terms and definitions and an orderly system to follow, ISO 11607-1 and -2 packaging standards provide requirements for sterile barrier packaging design, development, and validation to ensure sterile barrier integrity, aseptic presentation and packaging performance during transit.
In day-to-day operations, how do these guidelines interact, if at all? By dissecting the standards as they apply to each participant (MDM and packaging partner) the picture may be clearer. ISO 14971 calls for identifying all risks that apply to the medical device, which includes hazards related to the packaging system. It answers the “why” for the associated work product that must be done, first by the MDM and, regarding packaging risks, it answers the why that must be applied to the design, function, form and performance of the packaging system for that medical device, which then turns the focus to the packaging standards:
With the MDM’s input as to what risks are present for the medical device, ISO 11607-1 lays the groundwork for “what” the packaging partner must address. The ISO 11607-1 performance factors that the packaging system must achieve are second nature to packaging professionals, and the ISO 14971:2019 documentation from the MDM acts as a detailed roadmap to ensure both sides are in full compliance.
Once the packaging system is online, ISO 11607-2 kicks in, again, second nature, but from a standards perspective, completes the alignment of everyone’s work, addressing the “how,” through validations and controls to demonstrate compliant packaging designed according to the ISO 14791:2019 risk assessment and controls.
While this is a simplified look at how these standards (and players) work together, it illustrates an intentional, defined relationship between all parties and reduces isolated efforts of one party that may miss an important component.
The medical device industry and governing bodies around the world prioritize the pursuit of reliability, innovation and patient safety in the design and production of medical devices. If regulators, industry guardians and stakeholders remain committed to collaboration, due diligence and testing without shrinking back, excellence will continue to drive both the guiding standards and processes to protect and improve medical devices to the benefit of human health.
