The Data Act introduces new rules for accessing and using data generated by connected products, with relevant implications for the medical device sector.
Starting from 12 September 2026, manufacturers will need to consider new obligations related to data accessibility, security and interoperability.
In the medical field, however, making a device “data accessible” may require software changes, new APIs, updates to communication architectures and cybersecurity measures. These changes can have a direct impact on MDR compliance (Medical Device Regulation), especially when software contributes to the device’s safety, clinical performance and risk management.
The article explores the relationship between the Data Act and the Medical Device Regulation, highlighting the main technical and regulatory implications for the medtech sector.
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