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Table 2 Main differences between Directives and Regulations

From: Artificial intelligence as a medical device in radiology: ethical and regulatory issues in Europe and the United States

Directives Regulations
The directives set out the objectives that must be attained. Once they are in force, EU member states have a limited period of time to implement national legislation that will satisfy those objectives.   Regulations are applied directly in EU Member States, without the need for national legislation to implement their purposes. Once they are in force, member states must comply with them.
  1. EU European Union