Authorised representative

Any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation.

Reference: MDR Article 2(32); IVDR Article 2(25)

Distributor

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 into service.

Reference: MDR Article 2(34); IVDR Article 2(27)

Economic operator

A manufacturer, an authorised representative, an importer, a distributor or the person referred to in Article 22(1) and 22(3). Under the IVDR: a manufacturer, an authorised representative, an importer or a distributor.

Reference: MDR Article 2(35); IVDR Article 2(28)

Fully refurbishing

For the purposes of the definition of manufacturer, the complete rebuilding of a device already placed on the market or put into service, or the making of a new device from used devices, to bring it into conformity with this Regulation, combined with the assignment of a new lifetime to the refurbished device.

Reference: MDR Article 2(31); IVDR Article 2(24)

Health institution

An organisation the primary purpose of which is the care or treatment of patients or the promotion of public health. Under the IVDR: an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health; 02017R0746 — EN — 10.01.2025 — 005.001 — 7.

Reference: MDR Article 2(36); IVDR Article 2(29)

Importer

Any natural or legal person established within the Union that places a device from a third country on the Union market.

Reference: MDR Article 2(33); IVDR Article 2(26)

Lay person

An individual who does not have formal education in a relevant field of healthcare or medical discipline.

Reference: MDR Article 2(38); IVDR Article 2(31)

Manufacturer

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.

Reference: MDR Article 2(30); IVDR Article 2(23)

OBL — Own brand labelling

Placing another company’s device on the market under your own name or trade mark. Doing so makes you the manufacturer with all the accompanying obligations, unless there is an agreement under which the actual manufacturer is identified on the label and remains responsible.

Reference: MDR Article 16(1)(a); IVDR Article 16(1)(a)

PRRC — Person responsible for regulatory compliance

The individual a manufacturer must have available with defined qualifications or experience, responsible for release checks, technical documentation and the declaration of conformity, post-market surveillance obligations and vigilance reporting. Micro and small enterprises need not employ the person directly but must have one permanently at their disposal.

Reference: MDR Article 15; IVDR Article 15

Reprocessing

A process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the technical and functional safety of the used device.

Reference: MDR Article 2(39)

Reprocessing of single-use devices

The process applied to a used device to allow safe reuse, permitted only where national law allows it and only in accordance with the regulation and the relevant common specifications. Anyone reprocessing a single-use device is treated as the manufacturer of the reprocessed device.

Reference: MDR Article 17

User

Any healthcare professional or lay person who uses a device.

Reference: MDR Article 2(37); IVDR Article 2(30)