Machine configuration (EU 2023/1230) and MDR are changing documentation requirements. Structured data and eIFU ensure compliance.

EU Machinery Regulation (2023/1230) and the Medical Device Regulation (MDR) (EU 2017/745) now govern documentation management throughout a product's entire lifecycle. With transition periods currently underway, many organizations are finding it critical to modernize their documentation workflows.

The MDR allows electronic instructions for use (eIFU) for certain medical devices intended for professional use, provided that the publication process and risk management have been properly designed. The Machinery Regulation, in turn, places particular emphasis on the availability and usability of instructions. The provisions do not prescribe a specific technical format; what matters most is that the content is controlled, easy to find, and understandable for the user.

Leveraging HTML to meet Machinery Regulation and MDR Requirements

An HTML-based publication makes instructions easily accessible and usable. It creates excellent conditions for accessibility and for complying with international standards (such as WCAG) when the content is designed with the user in mind. End users can quickly access the correct instructions for their device, for example via a QR code. Browser-based instructions also enable manufacturers to distribute safety-related updates and additional guidance efficiently. The documentation package can furthermore be equipped with an identifier that verifies the instructions have remained unchanged. This supports version control and makes demonstrating compliance smoother, including in audit situations.

The most important driver of change is customer centricity. PDF instructions are difficult to use on mobile devices, and paper instructions are always in the wrong place when they are needed. HTML-based instructions, for example. Oxygen WebHelp provides instructions precisely when and where the user needs them. The manufacturer's responsibility must also be considered, especially for medical devices, where the availability of instructions is directly related to patient safety.

Solving Regulatory Challenges with Structured Documentation

Now is the perfect time to switch to structured documentation. All necessary formats can be produced from a single source of truth: print-ready PDF, HTML-based help, and other publications. Structured documentation and CCMS system ensure version control, traceability, and a managed release process. The same approved content is updated across all channels, supporting compliance and facilitating audits.

At Index IT, we have implemented numerous HTML solutions using both commercial and open-source technologies. We also support organizations in transitioning to structured documentation, defining and implementing CCMS solutions.

Sources and further reading:

BSI White Paper on Technical Documentation (PDF)

TEKOM Europe's Position Paper on the Machinery Regulation Application Guide (PDF)