Medical Devices Directive - Understanding your role.
The medical devices market is, nowadays, global. While the safety requirements are the same everywhere, the legal requirements for traders are different. If you are an economic operator acting in the EU and associated CE marking countries, you have to correctly identify what your legal role is under the Medical Devices Directive. You could be a manufacturer, an importer, an OBL (also called Virtual Manufacturer), a distributer or an Authorised Representative. This diagram allows you to correctly identify your legal role with a few simple questions. Once you know what your role is, you can select the correct products to purchase.