Conformity assessment body

A body that performs third-party conformity assessment activities including calibration, testing, certification and inspection.

Reference: MDR Article 2(41); IVDR Article 2(33)

Conformity assessment

The process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled.

Reference: MDR Article 2(40); IVDR Article 2(32)

Conformity assessment procedure

The route a manufacturer takes to demonstrate compliance, chosen according to the device’s classification. Routes combine quality management system assessment, technical documentation assessment and, for some devices, type-examination or product verification.

Reference: MDR Article 52 and Annexes IX to XI; IVDR Article 48 and Annexes IX to XI

Control material

A substance, material or article intended by its manufacturer to be used to verify the performance characteristics of a device.

Reference: IVDR Article 2(56)

Corrective action

Action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation.

Reference: MDR Article 2(67); IVDR Article 2(70)

CS — Common specifications

A set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system. Under the IVDR: a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system. Section 2 Regulatory status of products and counselling.

Reference: MDR Article 2(71); IVDR Article 2(74)

Device for near-patient testing

Any device that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient by a health professional.

Reference: IVDR Article 2(6)

Device for self-testing

Any device intended by the manufacturer to be used by lay persons, including devices used for testing services offered to lay persons by means of information society services.

Reference: IVDR Article 2(5)

Device for performance study

A device intended by the manufacturer to be used in a performance study. A device intended to be used for research purposes, without any medical objective, shall not be deemed to be a device for performance study.

Reference: IVDR Article 2(45)

Device deficiency

Any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in information supplied by the manufacturer. Under the IVDR: any inadequacy in the identity, quality, durability, reliability, safety or performance of a device for performance study, including malfunction, use errors or inadequacy in information supplied by the manufacturer.

Reference: MDR Article 2(59); IVDR Article 2(62)

Diagnostic sensitivity

The ability of a device to identify the presence of a target marker associated with a particular disease or condition.

Reference: IVDR Article 2(50)

Diagnostic specificity

The ability of a device to recognise the absence of a target marker associated with a particular disease or condition.

Reference: IVDR Article 2(49)

Distance sales

Devices offered through information society services to a person in the Union must comply with the regulation. This extends to devices not placed on the market but used to provide a diagnostic or therapeutic service remotely, and a copy of the declaration of conformity must be made available on request.

Reference: MDR Article 6; IVDR Article 6

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)

DoC — EU declaration of conformity

The manufacturer’s signed statement that a device meets the applicable requirements. It must be kept up to date, translated into the languages required by the Member States where the device is made available, and its minimum content is fixed by Annex IV.

Reference: MDR Article 19 and Annex IV; IVDR Article 17 and Annex IV

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)

EMDN — European Medical Device Nomenclature

The nomenclature used to describe and categorise devices in Eudamed. The regulations require an internationally recognised nomenclature to be made available free of charge; the EMDN is the system the Commission designated for that purpose.

Reference: MDR Article 26; IVDR Article 23

Ethics committee

An independent body established in a Member State in accordance with the law of that Member State and empowered to give opinions for the purposes of this Regulation, taking into account the views of laypersons, in particular patients or patients' organisations.

Reference: MDR Article 2(56); IVDR Article 2(59)

EUDAMED — European database on medical devices

The Commission-run database bringing together registration of devices and economic operators, the UDI database, notified bodies and certificates, clinical investigations or performance studies, vigilance and post-market surveillance, and market surveillance. Parts of it are public.

Reference: MDR Article 33; IVDR Article 30

EURL — European Union reference laboratory

A laboratory designated under the IVDR to verify the performance of class D devices and check batches, and to provide scientific and technical assistance to the Commission and Member States. There is no direct MDR equivalent.

Reference: IVDR Article 100