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EU Design Act: Designing the future - why the EU Design Act matters for medical devices

DigiCure: Legal insights at the intersection of Technology and Life Sciences and Health Care

07 April 2026

The EU Design Act (effective 1 May 2025 with further reforms effective 1 July 2026) has been introduced to strengthen, simplify, and modernize the EU design system and align it with EU trademark rules. This new reform will offer design protection that is fit for the era of digital designs and evolving technologies.

But what changes does the reform bring to your business? We address this question in a series of sector-specific articles featured in our "Designing the Future" series. The series started with the video games sector followed by fashion and furniture and automotive and mobility. In this article, we examine the implications of the reform for medical devices.

The changes in EU design law go far beyond administrative tweaks – the reform clearly opens the door to protect the very features that shape user experience and define new generation, software-driven medical devices, offering stronger tools against unauthorized imitations and 3D-printed copies of regulated products.

For the medical industry, the real breakthrough lies in the following developments: the protection of digital & dynamic designs, the protection against replication & 3D printing, and the repair clause allowing the production of “must match” spare parts.

Chapter 1 What’s new: What can be protected?

The EU Design Act introduces new opportunities for design protection:

Digital & Dynamic Designs

The EU Design Act extends design protection to digital and dynamic elements, including GUIs, animations and screen-based visuals.

The protection applies to the visual appearance of medical software interfaces, dashboards and interactive displays, even without a physical embodiment. This is particularly relevant for connected medical devices, digital health platforms and human-machine interfaces, where user experience becomes a key competitive asset.

Protection Against Replication & 3D Printing

The new framework strengthens enforcement against unauthorized reproduction, including the use and distribution of digital design files (e.g. CAD models).

This has a key impact on customized components, implants, surgical guides and device accessories. It enables manufacturers to maintain control over digital replication and decentralized manufacturing, including hospital-based or third-party 3D printing.

Repair Clause & Spare Parts

The repair clause limits design protection for component parts of complex products when used solely to restore the original appearance of the product.

This may allow third parties to produce compatible components for certain modular medical devices. However, in the medical sector this interacts with specific medical regulations and liability rules, meaning practical applicability remains highly regulated.

Chapter 2 Why it matters for you

MedTech industry can now protect far more than static product appearances. With a well-structured design portfolio, competitors can no longer easily replicate the visual and interactive features of innovative medical interfaces and systems. This significantly strengthens the ability to act against unauthorized imitations and unregulated copies of medical products.

Chapter 3 How to protect these new designs

The technical standards for representing dynamic and animated designs will be finalized by 1 July 2026.

Article 26 of the EU Design Directive already allows design representations in static, dynamic, or animated formats, using commonly available technologies (drawings, images, videos, computer-generated models). In the medical device sector, this enables the protection of software interfaces, dynamic dashboards, and interactive system behaviours, with interactive 3D models or simulations emerging as key tools for design registration.

Chapter 4 What we recommend

The reform provides an opportunity to refine your design protection strategy and fully utilize the new options to legally secure the features that shape user experience and brand identity and shield them from unauthorized use and copycats.

We recommend that you

Educate teams: Brief creative and product development teams on the new scope of design protection in the EU.
Audit assets: Identify key interfaces, dashboards, interactive visualizations, animations, and 3D simulations that may be eligible for design protection (keeping in mind the novelty requirement).
Strategize: Develop filing strategies for protecting your key assets.
Monitor developments: Track the July 2026 technical rules and further category expansions.
File early: Begin submitting design applications for key visual features that define your medical devices.
Signal protected design status: Consider using the new registration symbol Ⓓ to raise awareness and deter infringers.

We are happy to assist you!

Authored by Alessandra Pannozzo

This article is the 17th in our series, “DigiCure: Legal insights at the intersection of Technology and Life Sciences and Health Care,” which aims to help you stay informed about the broad array of legal and regulatory issues affecting companies operating at the intersection of the technology and life sciences & health care sectors. From using AI in clinical studies, to evolving patient data concerns, to the entire digital health product lifecycle, our team will discuss novel issues arising in all parts of the world, including unique deal-making, litigation, and compliance concerns. Ensure you are subscribed to Our Thinking to receive these new insights!