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 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)

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

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)

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)

Kit

A set of components that are packaged together and intended to be used to perform a specific in vitro diagnostic examination, or a part thereof.

Reference: IVDR Article 2(11)

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)

LDT — Laboratory developed test

An IVD developed and used within a single laboratory rather than placed on the market. In the EU these fall under the health institution exemption in IVDR Article 5(5) rather than being a separate regulatory category, so the exemption conditions determine what is permitted.

Reference: IVDR Article 5(5)

Legacy device

A device CE marked under the Medical Device Directive 93/42/EEC or the Active Implantable Medical Devices Directive 90/385/EEC and placed on the market under the MDR transitional arrangements. Not an MDR term: it comes from guidance, and it governs what level of clinical evidence is expected during transition.

Reference: MDCG 2020-6

Likelihood ratio

The likelihood of a given result arising in an individual with the target clinical condition or physiological state compared to the likelihood of the same result arising in an individual without that clinical condition or physiological state.

Reference: IVDR Article 2(54)

Making available on the market

Any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge. Under the IVDR: any supply of a device, other than a device for performance study, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge.

Reference: MDR Article 2(27); IVDR Article 2(20)

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)

Market surveillance

The activities carried out and measures taken by competent authorities to check and ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection. Under the IVDR: the activities carried out and measures taken by public authorities to check and ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection.

Reference: MDR Article 2(61); IVDR Article 2(64)

MCID — Minimal clinically important difference

The smallest change in an outcome measure that a patient would perceive as meaningful. Used when setting clinical benefit and outcome parameters, so that statistically significant results are not mistaken for clinically relevant ones. A clinical research concept, not a regulatory definition.