The ever-evolving world of medical devices is not just limited to technological advancements; medical device regulations are constantly adapting to ensure the safety, performance, and efficacy of medical devices for patients.
Have a look at the new entry of Asphalion’s MedTech blog here: CHANGES IN MEDICAL DEVICE REGULATIONS_NAVIGATING THE NEW LANDSCAPE
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In the rapidly evolving medical device industry, ensuring the safety and efficacy of products is paramount. ISO 14971:2019 serves as the cornerstone for risk management
The EHDS Regulation has three main parts, each with different addressees:
Chapter II on primary use provides additional rights to patients and establishes the technical infrastructure necessary for their implementation.
Chapter III on Electronic Health Record (EHR) systems is addressed to manufacturers and other economic operators who make EHR systems available on the market.
Chapter IV on secondary use is addressed to health data holders and users.
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