In accordance with the Regulation (EU) 2017/745 on medical devices, economic operators (natural and legal persons carrying out business activities) who carry out business activities connected to medical devices, such as putting them on the market or into service, making them available on the market, or have been given a mandate by a manufacturer from a third country to represent it in the EU market, have certain obligations. They are regulated entities.
‘Manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark.
‘Authorised representative’ means any natural or legal person established within the European Union who has received and accepted a written mandate from a manufacturer, located outside the European Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under this Regulation.
Where the manufacturer of a device is not established in an EU Member State and does not have an authorised representative in an EU Member State, their device shall not be placed on the EU market.
‘Importer’ means any natural or legal person established within the European Union that places a device from a third country on the EU market.
‘Distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer that makes a device available on the market, up until the point of putting it into service.
MANUFACTURER OF CUSTOM-MADE DEVICES
‘Manufacturer of custom-made devices’ means a natural or legal person who manufactures or fully refurbishes a custom-made device or has a custom-made device designed, manufactured or fully refurbished, and markets that device under its name or trademark.
- orthoses and prostheses
- dental appliances (including dental braces and dentures, etc.)
- hearing aids
Please note! The vast majority of opticians/eye clinics, according to the definition of a custom-made device and the European harmonisation rules/guidelines MDCG 2021-3 Questions and Answers on Custom-Made Devices, are not manufacturers, but distributors or importers of devices by making them available, even if they are slightly customised or prepared for the end-user.
‘Custom-made device‘ means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person’s professional qualifications which gives, under that person’s responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs. However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices.
You can find more detailed descriptions of individual regulated entities, emphasising the difference between them based on their activities with the devices in the instructions for completing the application for the registration of economic operators – here.