Triple

Target class: EU medical devices legislation
Context triple: [Council Directive 90/385/EEC, instanceOf, EU medical devices legislation]

• A. medical device regulation system
  A medical device regulation system is a framework of processes, rules, and oversight mechanisms that govern the evaluation, approval, monitoring, and post-market surveillance of medical devices to ensure their safety, effectiveness, and compliance with regulatory standards.
• B. European Union regulation
  A European Union regulation is a binding legislative act that applies directly and uniformly in all EU member states without needing national implementing measures, establishing common rules and standards across the Union.
• C. EU legal act chosen
  An EU legal act is a binding or non-binding instrument adopted by the European Union’s institutions—such as regulations, directives, decisions, recommendations, or opinions—to create, modify, or guide the application of law within the EU legal order.
• D. organ of the European Medicines Agency
  An organ of the European Medicines Agency is a formal decision-making or advisory body within the EMA’s governance structure, such as its Management Board, Executive Director, or scientific committees, responsible for specific regulatory, administrative, or scientific functions.
• E. medical device
  A medical device is any instrument, apparatus, machine, implant, or similar article intended for use in diagnosing, preventing, monitoring, treating, or alleviating disease or other medical conditions in humans or animals.
• F. None of above.