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 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)

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)

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)

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

Harmonised standard

A European standard as defined in point (1)(c) of Article 2 of Regulation (EU) No 1025/2012.

Reference: MDR Article 2(70); IVDR Article 2(73)

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)

HIE — Health institution exemption

The route allowing a health institution to manufacture and use devices internally without full conformity assessment, subject to conditions: the devices are not transferred to another legal entity, they are made under an appropriate quality management system, a public declaration is drawn up, and no equivalent device on the market meets the patient group’s needs at the required performance level.

Reference: MDR Article 5(5); IVDR Article 5(5)

HRI — Human readable interpretation

A legible interpretation of the data characters encoded in the UDI carrier.

Reference: MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1

IMDRF — International Medical Device Regulators Forum

A voluntary group of medical device regulators working towards converged regulatory approaches. Its documents carry no legal force in the EU, but several are referenced by MDCG guidance and are used to fill gaps where EU guidance is silent.

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)

In vitro diagnostic medical device

Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following: (a) concerning a physiological or pathological process or state; (b) concerning congenital physical or mental impairments; (c) concerning the predisposition to a medical condition or a disease; (1) Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery (OJ L 157, 9.6.2006, p. 24). 02017R0746 — EN — 10.01.2025 — 005.001 — 4 (d) to determine the safety and compatibility with potential recipients; (e) to predict treatment response or reactions; (f) to define or monitoring therapeutic measures. Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices.

Reference: IVDR Article 2(2)

Incident

Any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect. Under the IVDR: any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any harm as a consequence of a medical decision, action taken or not taken on the basis of information or result(s) provided by the device.

Reference: MDR Article 2(64); IVDR Article 2(67)

Informed consent

A subject's free and voluntary expression of his or her willingness to participate in a particular clinical investigation, after having been informed of all aspects of the clinical investigation that are relevant to the subject's decision to participate or, in the case of minors and of incapacitated subjects, an authorisation or agreement from their legally designated representative to include them in the clinical investigation. Under the IVDR: a subject's free and voluntary expression of his or her willingness to participate in a particular performance study, after having been informed of all aspects of the performance study that are relevant to the subject's decision to participate or, in the case of minors and of incapacitated subjects, an authorisation or agreement from their legally designated representative to include them in the performance study.

Reference: MDR Article 2(55); IVDR Article 2(58)

Instructions for use

The information provided by the manufacturer to inform the user of a device's intended purpose and proper use and of any precautions to be taken.

Reference: MDR Article 2(14); IVDR Article 2(14)

Intended purpose

The use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation. Under the IVDR: the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements or as specified by the manufacturer in the performance evaluation.

Reference: MDR Article 2(12); IVDR Article 2(12)

Interoperability

The ability of two or more devices, including software, from the same manufacturer or from different manufacturers, to: (a) exchange information and use the information that has been exchanged for the correct execution of a specified function without changing the content of the data, and/or (b) communicate with each other, and/or (c) work together as intended.

Reference: MDR Article 2(26); IVDR Article 2(19)

Interventional clinical performance study

A clinical performance study where the test results may influence patient management decisions and/or may be used to guide treatment.

Reference: IVDR Article 2(46)