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.

Implantable device

Any device, including those that are partially or wholly absorbed, which is intended: — to be totally introduced into the human body, or — to replace an epithelial surface or the surface of the eye, by clinical intervention and which is intended to remain in place after the procedure. Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device.

Reference: MDR Article 2(5)

Implant card

The card supplied with an implantable device carrying the information needed to identify it, including name, serial or lot number and UDI, together with warnings and precautions. The health institution makes it available to the patient.

Reference: MDR Article 18

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)

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)

Indication — Indication for use

The clinical condition to be diagnosed, prevented, monitored, treated, alleviated, compensated for, replaced, modified or controlled by the device. Distinct from intended purpose, which describes the effect of the device: every device has an intended purpose, but not every device has an indication.

Reference: MDCG 2020-6

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 use

Not defined in the MDR, which defines intended purpose instead. Guidance treats the two as carrying the same meaning, so a device file may use either term provided it does so consistently.

Reference: MDCG 2020-6

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)

Invasive device

Any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body.

Reference: MDR Article 2(6)

Investigational device

A device that is assessed in a clinical investigation.

Reference: MDR Article 2(46)

Investigator

An individual responsible for the conduct of a clinical investigation at a clinical investigation site. Under the IVDR: an individual responsible for the conduct of a performance study at a performance study site.

Reference: MDR Article 2(54); IVDR Article 2(48)

Label

The written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices.

Reference: MDR Article 2(13); IVDR Article 2(13)

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)