How Lack Of Clarity In The EU Data Act Could Cause Confusion For Medtech

Several elements of the EU Data Act proposal will apply to the medical device industry. An expert researcher outlines where clarity is needed to prevent issues with interpretation, particularly in the fields of cybersecurity and data sharing.

Analysis of the European Commission’s proposed Data Act has revealed potential areas of concern for medical devices, according to Elisabetta Biasin, an expert researcher who has published academic papers on EU cybersecurity legislation and medical devices.

In a report Biasin noted that the Data Act is a horizontal regulation that “leaves room” for sector-specific legislation, such as the Medical Device and In Vitro Diagnostics Regulations...

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