ARTICLE · 06 OCTOBER 2026

The Data Act: “Access By Design” Requirement Comes Into Force For Medical Devices

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The Data Act's "access by design" requirement came into force on 12 September 2026, mandating that manufacturers of connected products and providers of related services must enable direct user access to generated data by default. This article examines the scope of this new obligation and its practical implications for businesses in the Life Sciences sector, particularly those developing medical devices and Internet of Things products.

IrelandPrivacy

Davinia Brennan

Sarah Jayne Hanna

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On 12 September 2026, the “access by design” requirement under Article 3(1) of the Data Act (EU Regulation 2023/2854) (“the Data Act”) came into force. The new requirement applies to in-scope businesses placing connected products and related services on the market from 12 September 2026 onwards. The “access by design” requirement will be welcomed by consumers and businesses that use connected products and related services, who will now have direct access to the data they generate. Users will also be able to share their data with third parties like repair and maintenance services. Until now, manufacturers and providers of related services were only required to make relevant data available to users on request.

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