Derivative

A ‘non-cellular substance’ extracted from human or animal tissue or cells through a manufacturing process. The final substance used for manufacturing of the device in this case does not contain any cells or tissues.

Reference: MDR Article 2(17)

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)

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)

eIFU — Electronic instructions for use

Instructions supplied in non-paper form rather than on paper. Permitted only to the extent and under the conditions set by the regulation and the Commission implementing regulation on electronic instructions for use, which restricts which devices qualify and requires paper copies to remain available on request.

Reference: MDR Annex I Section 23.1(f)

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

Equivalence

The basis on which clinical data relating to another device may be used to support a clinical evaluation, provided technical, biological and clinical characteristics are sufficiently similar that no clinically significant difference in safety or performance results. The manufacturer must also demonstrate sufficient access to the other device’s data.

Reference: MDR Annex XIV Part A point 3; MDCG 2020-5

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

Expert panel

A body of independent experts appointed to give scientific, technical and clinical opinions, including views on clinical evaluation under the consultation procedure and on common specifications.

Reference: MDR Article 106

Falsified device

Any device with a false presentation of its identity and/or of its source and/or its CE marking certificates or documents relating to CE marking procedures. This definition does not include unintentional non-compliance and is without prejudice to infringements of intellectual property rights.

Reference: MDR Article 2(9); IVDR Article 2(10)

Field safety notice

A communication sent by a manufacturer to users or customers in relation to a field safety corrective action.

Reference: MDR Article 2(69); IVDR Article 2(72)

Field safety corrective action

Corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market.

Reference: MDR Article 2(68); IVDR Article 2(71)

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)

Gap assessment

A structured comparison of existing technical documentation and processes against the requirements that now apply, producing a list of what must change. An industry practice rather than a regulatory requirement, most often run when moving a device from the directives to the regulations.

Generic device group

A set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics.

Reference: MDR Article 2(7); IVDR Article 2(8)

Grandfathering

Carrying a device’s existing approval forward into a new regulatory framework without reassessment. The MDR contains no such mechanism: devices certified under the directives must be assessed against the regulation, with the transitional provisions governing only how long the old certificates remain valid.

GSPR — General safety and performance requirements

The set of requirements every device must meet before it can be CE marked, covering general safety, design and manufacture, and the information supplied with the device. Compliance is demonstrated requirement by requirement, and the evidence sits in the technical documentation. Requirements that do not apply to a given device must be justified rather than ignored.

Reference: MDR Annex I; IVDR Annex I