11/14/2024 | News release | Distributed by Public on 11/14/2024 08:20
The above-mentioned legislation regulates the safety and performance of medical technology (i.e. Medical Devices Regulation and In vitro Diagnostic Regulation) as well as market surveillance legislation more in general, including the General Data Protection Regulation (GDPR), the Product Liability and Artificial Intelligence Liability Directives, as well as the Representative Actions Directive. The latter rules are European Union (EU) 'horizontal' rules, and not sector specific.
In view of this matrix of rules, as well as the companies' commitment to highest standards of product safety, security and data protection, it is important to ensure consistency of these rules to foster medical technology innovation and access of safe and effective medical technologies in the EU.
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