MEDICAL DEVICE REGULATION EUROPE What is the difference between Regulation and Directive? What permission is required to get your medical device to be sold in Europe? There are quite differences between regulation and directive. Firstly, a competent authority has 28 member states in the EU and each one of this member states have it’s own competent authority ,therefore, to publish and to direct are in their responsibility. The rules come from the European Commission as a pioneer. Notified body audit manufacturers to ensure compliance with European Union rules. Secondly, there are 3 directives that are rule. The organizations need to follow this 3 directives in order to manufacture a medical device, to get permission and also to set up the medical device in Europe; a) Active Implantable Medical Device Directive, b) The Medical Device Directive, c) The Directive of in Vitro Diagnostic Medical Devices. Then, in medical devices, categorization is also s...