Technical documentation is a universal requirement for all types of medical devices, including MDSW
Ensuring compliance with MDR or IVDR is a fundamental aspect of bringing any medical device to market. Medical Device Software (MDSW), although intangible, shares this imperative.
Technical documentation serves as the backbone of regulatory compliance and quality assurance. It encapsulates the entire lifecycle of the software, from its conception to its deployment in clinical settings.
The MDR explicitly outlines the requirements for the technical documentation of MDSW in Article 10(4) and Annexes II and III. This introduces heightened standards for the content and structure of technical documentation, emphasizing clarity, organization, searchability, and precision. Annexes II and III of the regulation specify the components to be included, covering the following aspects:
- device description and specifications, including variations and accessories;
- manufacturer-supplied information;
- design and manufacturing particulars;
- overarching safety and performance criteria;
- risk-benefit assessment and risk management;
- product verification and validation during the pre-market phase.
Besides, like any other medical device, any MDSW available on the market must have an associated post-market surveillance plan in line with Article 84, a post-market surveillance report as per Article 85, and, for devices classified as IIa or higher, a periodic safety update report according to Article 86 (PSUR). The recently introduced PMCF evaluation report is now an integral part of the PSUR.
What is so special about technical documentation for Medical Device Software
As mentioned above, similar to any other medical device, Medical Device Software available on the market must be accompanied by technical documentation.
However, there are distinct differences in the nature of this documentation due to the intangible nature of MDSW. Unlike tangible medical devices, we skip the inclusion of documents related to raw materials, sterility, biocompatibility, electric safety (even though Medical Device Software is considered an active medical device), and similar physical attributes.
Instead, the focus shifts towards critical aspects such as usability verification, adhering to the guidelines outlined in ISO 62366-1. This ensures that the software is user-friendly and meets the necessary ergonomic standards for safe and effective use in a clinical setting. Furthermore, life cycle management in accordance with ISO 62304 becomes paramount. This entails rigorous planning, verification, and validation processes throughout the software's life cycle to guarantee its reliability and functionality.
In addition to these, MDSW necessitates documentation demonstrating robust information security measures. Given the sensitive nature of medical data, it is imperative that the software provides a secure environment for handling, storing, and transmitting patient information. This documentation provides crucial evidence of the software's compliance with stringent data protection standards.
In summary...
In essence, while the fundamental principles of technical documentation remain consistent across all medical devices, understanding the unique requirements for MDSW is important. By recognizing these distinctions, manufacturers should address them in their documentation, ensuring a smoother certification process and paving the way for successful market entry with the CE-marking. The technical documentation for MDSW must emphasize elements that are intrinsic to the medical software's functionality and safety. By prioritizing usability, life cycle management, and information security, you ensure that MDSW not only meets regulatory requirements but also delivers a high standard of performance and patient safety in the healthcare ecosystem.
