Navigating Software Regulations and Standards for IVD Medical Devices
In the In Vitro Diagnostic (IVD) medical devices sector, navigating and complying with relevant regulations and standards is essential for market access and determining the product’s classification. The choice of regulatory frameworks largely hinges on the target market and the device’s risk category within that market.
The industry recognizes three cornerstone standards for IVD medical devices:
- ISO 13485, which sets forth the requirements for quality management systems for regulatory purposes.
- ISO 14971, dedicated to risk management applications for medical devices.
- IEC 62304, which outlines the life cycle processes for medical device software development (SDLC).
The classification of IVD medical devices varies by country, yet universally, it is based on the risk level posed to patients and users. Devices presenting lower risks are classified in lower categories (e.g., Class A/I), while those with higher risks are placed in higher categories (e.g., Class D/IV).
Software development considerations for IVD medical devices
Software development, whether subject to specific regulations and standards or not, adheres to a structured process known as the software development lifecycle (SDLC). This process is organized into distinct steps, which may occur sequentially or concurrently, depending on the development model employed.
As mentioned, software within IVD medical devices, whether embedded, accessory, or standalone, requires compliance with specific regulations and standards, notably IEC 62304.
In general, the software development life cycle includes 7 key steps:
- Planning,
- Requirements analysis (software requirements and user requirements),
- Designing,
- Implementation of requirements,
- Design and testing,
- Deployment, and
- Maintenance.
The development model selection, such as the waterfall, V-model, agile, or iterative, depends on the project’s nature.
The V-model, including its agile iteration, is notably suitable for IVD device software, ensuring that each step in the verification phase has a corresponding validation phase step.
Thinking about outsourcing software development for IVD medical devices?
Outsourcing the development of IVD medical device software can offer several advantages, including accelerated market access, focus on core competencies, and access to regulatory expertise.
By leveraging external resources, companies can expedite product development, allowing for quicker market entry and revenue generation. Outsourcing also enables companies to maintain focus on their primary expertise while benefiting from the technical skills of their partners.
Furthermore, navigating the complex landscape of regulations and standards for IVD medical devices requires specific expertise, which can be efficiently sourced through outsourcing.
Documentation
The key distinction in creating software for In Vitro Diagnostic (IVD) medical devices compared to non-regulated software lies in the comprehensive documentation required.
The scope of this documentation is influenced by several factors, including the regulations and standards to be adhered to, the software’s risk classification, its type (whether embedded, accessory, or standalone), and the developer’s role (as either the legal manufacturer or a supplier).
During the entire software development lifecycle for IVD medical devices, it’s critical to implement and monitor risk management activities, which are documented in the risk management file. The purpose of this extensive documentation is to ensure traceability — linking software requirements to tests and both the high- and low-level architectural designs.
Specifically, for accessory or standalone IVD medical device software, adherence to the IEC 62304 standard is required. This means that each phase of the software development process must be accompanied by its respective documentation.
Summary
To sum up, successfully developing and classifying In Vitro Diagnostic (IVD) medical devices hinges on a comprehensive grasp of the relevant regulations and standards. These guidelines differ based on the intended market and the device’s risk level.
Key standards include ISO 13485, ISO 14971, and IEC 62304. Additionally, the classification of IVD medical devices is country-specific but typically based on the associated risk to patients and users, categorizing lower-risk devices into less stringent classes.
Curious to delve deeper into regulations for IVD medical device software development? Download the whitepaper from the experts on this topic, which covers an overview of classification systems that are used in different countries, and a checklist of documents required in the process of IVD medical device software development according to IEC 62304.
