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ViewAttendees 28

Medical Devices

Domain: Ethics

Knowledge Area: Legal & Regulatory Requirements

Data Security & Digital Health: Medical Devices, IVDs and the Increasing EU Regulation of Health Data

Thursday, May 11, 2023
09:00 – 10:00 CEST
Location: Pearl 3

Supported by 
Description: While the MDR and IVDR regulate market access of medical devices and IVDs in Europe, every device in scope of these regulations that processes patient data in some way (for example often just by running software) is also affected by an increasing number of EU regulations that concern personal data processed by market actors and devices in some way, such as the General Data Protection Regulation, the AI Regulation, the e-Privacy Regulation, the European Health Data Space (EHDS) regulation and the Data Governance Act. This session will describe how these regulations dovetail with the MDR and IVDR, how they overlap and interact amongst themselves, in what various stages of adoption they are and how market actors placing devices on the market or deploying them can be compliant with these rules.

Learning Objectives:

  • Understand how the MDR and IVDR dovetail with the various EU regulations that concern processing of personal data (concerning health).
  • Understand how the various EU regulations that concern processing of personal data (concerning health) interact with each other and how they apply to medical devices and IVDs
  • Learn to analyse impact of data processing on medical device and IVDs design and deployment and how to formulate company strategy for continued compliance.