Registration of medical devices

The JAZMP maintains the Register of medical devices of manufactures, or their representatives established in the Republic of Slovenia, of devices in accordance with the Council Directive 93/42/EEC, Council Directive 90/385/EEC and the Directive 98/79/EC, and of devices in accordance with the Regulation (EU) 2017/745 – MDR.

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.

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