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)

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)

MDSW — Medical device software

Software intended to be used, alone or in combination, for a medical purpose as set out in the definition of a medical device. Guidance distinguishes software that drives or influences a hardware device from software with an independent medical purpose, which is a device in its own right.

Reference: MDCG 2019-11

Medical device

Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: — diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, — diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, — investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, — providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. The following products shall also be deemed to be medical devices: — devices for the control or support of conception; — products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point. (1) Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24). Under the IVDR: ‘medical device’ as defined in point (1) of Article 2 of Regulation (EU) 2017/745.

Reference: MDR Article 2(1); IVDR Article 2(1)

MIR — Manufacturer incident report

The standard form used to report a serious incident to a competent authority under the vigilance system. The form and its coding are set out in Commission guidance rather than in the regulation itself, which specifies the reporting deadlines and the content required.

Reference: MDR Article 87; IVDR Article 82

NANDO — New Approach Notified and Designated Organisations

The Commission database listing notified bodies and the scope each is designated for. A designation takes effect the day after the notification is published there, so it is the authoritative source for checking whether a body may lawfully assess a given device type.

Reference: MDR Article 42; IVDR Article 38

Negative predictive value

The ability of a device to separate true negative results from false negative results for a given attribute in a given population; 02017R0746 — EN — 10.01.2025 — 005.001 — 9.

Reference: IVDR Article 2(53)

Notified body

A conformity assessment body designated in accordance with this Regulation.

Reference: MDR Article 2(42); IVDR Article 2(34)

OBL — Own brand labelling

Placing another company’s device on the market under your own name or trade mark. Doing so makes you the manufacturer with all the accompanying obligations, unless there is an agreement under which the actual manufacturer is identified on the label and remains responsible.

Reference: MDR Article 16(1)(a); IVDR Article 16(1)(a)

Packaging levels

The various levels of device packaging that contain a defined quantity of devices, such as a carton or case.

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

PEP — Performance evaluation plan

The plan setting out how scientific validity, analytical performance and clinical performance will be demonstrated for an IVD, including the intended purpose, the analyte or marker concerned, the characteristics to be evaluated and the acceptance criteria.

Reference: IVDR Annex XIII Part A point 1.1

PER — Performance evaluation report

The document in which the manufacturer assesses the scientific validity, analytical performance and clinical performance reports together, and states the clinical evidence supporting the intended purpose. It sits in the technical documentation alongside the performance evaluation plan.

Reference: IVDR Annex XIII Part A point 1.3.2

Performance study plan

A document that describes the rationale, objectives, design methodology, monitoring, statistical considerations, organisation and conduct of a performance study.

Reference: IVDR Article 2(43)