Impact of EU Regulations on Documentation

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 main driver for this shift is customer-centricity. PDFs are cumbersome on mobile devices, and paper manuals are rarely where you need them. HTML-based solutions, such as Oxygen WebHelp, provide guidance exactly when and where the user needs it. Manufacturer liability is also a factor, especially with medical devices where the availability of instructions is directly linked to patient safety.

Solving Regulatory Challenges with Structured Documentation

Now is the time to move to structured documentation. Using a single, managed source allows you to generate all required formats—from print-ready PDFs to HTML-based guides and other digital outputs. Structured documentation and a CCMS (Component Content Management System) ensure robust version control, traceability, and a managed publication process. Once content is approved, it updates automatically across all channels, supporting compliance and streamlining audits.

At Index IT, we have implemented numerous HTML solutions using both commercial and open-source technologies. We help organizations transition to structured documentation, define CCMS requirements, and manage the implementation process.

Sources and further reading:

https://www.bsigroup.com/contentassets/c48f4dd0aa8d4042987a2fbe72c3e086/white_paper__technical_documentation_web_v3.pdf

https://www.technical-communication.org/fileadmin/tekom.eu/Technical_Communication/2026-01-19_tekom_Europe_position_paper_on_EC_Guide_to_application_Machinery_Regulation.pdf