MDR and IVDR Glossary: Article 2 Definitions in Full

The definitions below are quoted word for word from Article 2 of Regulation (EU) 2017/745 (MDR) and Article 2 of Regulation (EU) 2017/746 (IVDR), consolidated texts on EUR-Lex. Each entry is followed by a short note and a link to the page where we discuss the term in context. Where the MDR and the IVDR use the same wording, the MDR text is given.

Devices and what they are for

Medical device

MDR Article 2(1): "‘medical device’ means 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."

Whether a product meets this definition is the first question in any MDR project; see is my product a medical device.

Accessory for a medical device

MDR Article 2(2): "‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);"

Accessories are classified in their own right under Annex VIII Section 3.2.

Custom-made device

MDR Article 2(3): "‘custom-made device’ means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs. However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices;"

Custom-made devices follow Annex XIII instead of CE marking; see custom-made devices.

Generic device group

MDR Article 2(7): "‘generic device group’ means 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;"

A mandate covers at least one whole generic device group; see the sole authorised representative rule.

Single-use device

MDR Article 2(8): "‘single-use device’ means a device that is intended to be used on one individual during a single procedure;"

Procedure pack

MDR Article 2(10): "‘procedure pack’ means a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose;"

Procedure packs are placed on the market under Article 22; see systems and procedure packs.

System

MDR Article 2(11): "‘system’ means a combination of products, either packaged together or not, which are intended to be inter-connected or combined to achieve a specific medical purpose;"

Intended purpose

MDR Article 2(12): "‘intended purpose’ means 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;"

Intended purpose drives classification, clinical evaluation and labelling; see medical device classification.

Label

MDR Article 2(13): "‘label’ means 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;"

Label content is set by Annex I Section 23.2; see labelling requirements.

Instructions for use

MDR Article 2(14): "‘instructions for use’ means 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;"

Unique Device Identifier

MDR Article 2(15): "a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market;"

See Basic UDI-DI, UDI-DI and EUDAMED DI and UDI carrier requirements.

Placing on the market and economic operators

Making available on the market

MDR Article 2(27): "‘making available on the market’ means 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;"

See placing on the market vs making available.

Placing on the market

MDR Article 2(28): "‘placing on the market’ means the first making available of a device, other than an investigational device, on the Union market;"

Putting into service

MDR Article 2(29): "‘putting into service’ means the stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose; ▼C1"

Manufacturer

MDR Article 2(30): "‘manufacturer’ means 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 trade mark; ▼B"

Relabelling or marketing under your own name can make you the manufacturer; see MDR Article 16.

Authorised representative

MDR Article 2(32): "‘authorised representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation;"

The role is set out in Article 11; see our EU authorized representative guide.

Importer

MDR Article 2(33): "‘importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market;"

See importer obligations under Article 13.

Distributor

MDR Article 2(34): "‘distributor’ means 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;"

See distributor obligations under Article 14.

Economic operator

MDR Article 2(35): "‘economic operator’ means a manufacturer, an authorised representative, an importer, a distributor or the person referred to in Article 22(1) and 22(3);"

How the roles fit together is compared in EU AR vs importer vs distributor vs PRRC.

Health institution

MDR Article 2(36): "‘health institution’ means an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health;"

See the health institution exemption in Article 5(5).

Reprocessing

MDR Article 2(39): "‘reprocessing’ means a process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the technical and functional safety of the used device;"

See reprocessing single-use devices under Article 17.

Conformity assessment

Conformity assessment

MDR Article 2(40): "‘conformity assessment’ means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled;"

Notified body

MDR Article 2(42): "‘notified body’ means a conformity assessment body designated in accordance with this Regulation;"

See notified bodies under the MDR.

CE marking

MDR Article 2(43): "a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing;"

See CE marking for medical devices.

Harmonised standard

MDR Article 2(70): "‘harmonised standard’ means a European standard as defined in point (1)(c) of Article 2 of Regulation (EU) No 1025/2012;"

Common specifications

MDR Article 2(71): "a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system."

Clinical evidence

Clinical evaluation

MDR Article 2(44): "‘clinical evaluation’ means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;"

See clinical evaluation under Article 61.

Clinical investigation

MDR Article 2(45): "‘clinical investigation’ means any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device;"

Clinical data

MDR Article 2(48): "‘clinical data’ means information concerning safety or performance that is generated from the use of a device and is sourced from the following: — clinical investigation(s) of the device concerned, — clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated, — reports published in peer reviewed scientific literature on other clinical experience of either the device in question or a device for which equivalence to the device in question can be demonstrated, — clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up;"

Clinical evidence

MDR Article 2(51): "‘clinical evidence’ means clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer;"

Clinical benefit

MDR Article 2(53): "‘clinical benefit’ means the positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health;"

Post-market surveillance and vigilance

Post-market surveillance

MDR Article 2(60): "‘post-market surveillance’ means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;"

See post-market surveillance and the PSUR under Article 86.

Market surveillance

MDR Article 2(61): "‘market surveillance’ means 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;"

Authorities act through Articles 93 to 100; see competent authority requests.

Recall

MDR Article 2(62): "‘recall’ means any measure aimed at achieving the return of a device that has already been made available to the end user;"

Withdrawal

MDR Article 2(63): "‘withdrawal’ means any measure aimed at preventing a device in the supply chain from being further made available on the market;"

Incident

MDR Article 2(64): "‘incident’ means 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;"

Serious incident

MDR Article 2(65): "‘serious incident’ means any incident that directly or indirectly led, might have led or might lead to any of the following: (a) the death of a patient, user or other person, (b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health, (c) a serious public health threat;"

Reporting deadlines are covered in serious incident reporting.

Corrective action

MDR Article 2(67): "‘corrective action’ means action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation;"

Field safety corrective action

MDR Article 2(68): "‘field safety corrective action’ means 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;"

Field safety notice

MDR Article 2(69): "‘field safety notice’ means a communication sent by a manufacturer to users or customers in relation to a field safety corrective action;"

IVDR-specific terms

In vitro diagnostic medical device

IVDR Article 2(2): "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; (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;"

The IVDR definition; see IVDR classification.

Device for self-testing

IVDR Article 2(5): "any device intended by the manufacturer to be used by lay persons, including devices used for testing services offered to lay persons by means of information society services;"

Device for near-patient testing

IVDR Article 2(6): "any device that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient by a health professional;"

Companion diagnostic

IVDR Article 2(7): "a device which is essential for the safe and effective use of a corresponding medicinal product to: (a) identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or (b) identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product;"

Companion diagnostics are class C under Rule 3(f).

Kit

IVDR Article 2(11): "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;"

Scientific validity of an analyte

IVDR Article 2(38): "the association of an analyte with a clinical condition or a physiological state;"

Scientific validity is the first pillar of performance evaluation.

Analytical performance

IVDR Article 2(40): "the ability of a device to correctly detect or measure a particular analyte;"

Clinical performance

IVDR Article 2(41): "the ability of a device to yield results that are correlated with a particular clinical condition or a physiological or pathological process or state in accordance with the target population and intended user;"

Performance evaluation

IVDR Article 2(44): "an assessment and analysis of data to establish or verify the scientific validity, the analytical and, where applicable, the clinical performance of a device;"

Calibrator

IVDR Article 2(55): "a measurement reference material used in the calibration of a device;"

Control material

IVDR Article 2(56): "a substance, material or article intended by its manufacturer to be used to verify the performance characteristics of a device;"

Using this glossary

Definitions settle vocabulary, not obligations. Whether a definition applies to your product or your company depends on the facts, and the operative requirements sit in the articles and annexes that use these terms. For the representative role itself, start with our EU authorized representative guide or request a proposal.

Country guides

We have country pages for manufacturers in New Zealand, India, Pakistan, Bangladesh, Sri Lanka and Türkiye. All markets are in the list by country.

If your devices still need to be registered in EUDAMED, see our EUDAMED registration proposal.