Registration of economic operators

An economic operator means a legal or natural person who independently performs an activity entered in the Court Register or Business Register, or an activity established by a regulation or an economic operator’s articles of association. 

These include:

• Manufacturers of medical devices;
• Authorised representatives of manufacturers;
• Manufacturers of custom-made devices;
• Systems and procedure packs producers from Article 22 of Regulation (EU) 2017/745;
• Distributors of medical devices;
• Importers of medical devices;
• Health institutions manufacturing in-house devices for their own use,
• Reprocessors of medical devices.

Economic operators carrying out activities related to medical devices or in vitro diagnostic medical devices, such as manufacturing or reprocessing of medical devices, placing them on the market or putting them into service, making them available on the market, or being authorised by a third-country manufacturer to represent them in the European Union market, are subject to certain obligations under Regulation (EU) 2017/745 on medical devices, Regulation (EU) 2017/746 on in vitro diagnostic medical devices and the Medical Devices Act (ZMedPri-1). These operators are regulated entities.