MedTech Europe provides feedback to the European Commission on the Cyber Resilience Act

Posted on 02.02.2023

MedTech Europe responded to the Commission’s call for feedback on the Cyber Resilience Act (CRA). The European medical technology industry is a critical provider of innovative, effective, and safe healthcare solutions for a great number of patients in Europe. Medical devices are becoming increasingly digitally connected, making cybersecurity and safety a core priority for manufacturers.

MedTech Europe welcomes the clear and comprehensive demarcation between the CRA and the sectorial regulation for the medical technology industry. The MDR/IVDR and the Medical Devices Coordination Group guidance on cybersecurity guarantees a high level of cybersecurity for medical device users and patients in line with CRA objectives.

MedTech Europe further calls on legislators to ensure clear and comprehensive regulatory interplay with existing and ongoing legislative developments such as the European Health Data Space. Read the complete feedback here.

For more information, please contact Benjamin Meany, Manager Digital Health – Medical Device Software Regulation.