Introduction to the EU Data Act




The EU Data Act (Regulation (EU) 2023/2854) is the core legislation of the EU data strategy. It entered into force on 11 January 2024 and has applied in full since 12 September 2025. It aims to build a single market for data, balance the interests of data holders and users, promote fair access to and flow of data, and strengthen data security and compliance. Below we explain its core purpose, key provisions, scope and compliance implications.

Download the EU Data Act at: https://eur-lex.europa.eu/eli/reg/2023/2854/oj/eng

The Data Act is a law that aims to strengthen the EU data economy and foster a competitive data market by making data (in particular industrial data) more accessible and usable, encouraging data-driven innovation and increasing data availability.

To achieve this, the Data Act ensures fairness in how the value of data is allocated among actors in the data economy. It clarifies who can use which data and under what conditions.

In recent years the supply of connected products on the European market has grown rapidly. Together these products form a network known as the Internet of Things (IoT), increasing the amount of data available for reuse in the EU. This offers huge potential for EU innovation and competitiveness.

The Data Act gives users of connected products (businesses or individuals who own, rent or lease such products) greater control over the data they generate, while maintaining incentives for those who invest in data technologies. It also sets out general conditions for situations where a business has a legal obligation to share data with another business.

The Data Act is divided into six main chapters

Overview of the chapters

Key changes in the 2025 extended model (compared with the 2019 version)

This is a series of educational articles introducing FDA, NMPA, GMP, CE MDR/IVDR and MDSAP regulations and standards.
EVERBIZ is happy to share medical device expertise with industry clients, and hopes our extensive practical experience in quality systems and product registration will be helpful.

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