Regulation, Standards & Compliance for Exported Products

Ecodesign aims to make products more resource-efficient and reduce their environmental impact. Legal requirements for ecodesign have been established in the European single market for two decades. However, European Regulation 2024/1781 on ecodesign for sustainable products has significantly expanded the framework for ecodesign, introducing comprehensive information requirements and the so-called ‘digital product passport’. How will the Regulation be applicable on a product-specific basis, and what challenges will this pose for products and those responsible for technical communication?

The presentation will demonstrate how to establish an end-to-end digital validation process through deep integration of CMS (Content Management System) and OA (Office Automation) systems. Key components include business requirement analysis, system architecture design, test environment consistency verification, and process deviation management. It will also showcase the development of a standardized validation solution database, bilingual translation of core functionalities, and the final quality review approval for deployment.

The Medical Device Regulation governs the regulation of medical devices in the European Union, enhancing safety, quality, and performance standards for medical devices. As a manufacturer of software for computer aided surgery, implants and surgical instruments intended for distribution the European market, we had to update the technical documentation and the labeling of all products in scope ensuring that the required enhancements in the product related user instructions and packaging information were available in the languages of target countries and online for public access. This presentation provides an overview on the regulatory labeling requirements for all medical device manufacturers and importers in Europe as well as example of how requirements were applied on the packaging, in the software and in the instructions for safe and effective use of the device.