Glossary of key terms
MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746) — terms are drawn from official definitions in Article 2 of each regulation unless otherwise noted.
Definitions are reproduced and paraphrased from official regulation text for reference purposes. Where precise legal meaning is required, always consult the original Article 2 definitions in the relevant regulation.
This glossary covers the key terms used across this site and in EU medical device regulation. Defined terms in MDR and IVDR appear in Article 2 of each regulation.
A
Accessory to a medical device
An article which, whilst not itself a medical device, is intended by its manufacturer to be used together with one or more specific medical devices to specifically enable or assist the device to be used, or to assist the safety or performance of the device. MDR Art. 2(2)
Accessory to an IVD
An article intended by its manufacturer to be used together with one or more specific IVDs to enable or assist the IVD to be used according to its intended purpose, or solely or principally to assist the safety or performance of the IVD. IVDR Art. 2(4)
Active device
Any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by converting this energy. Devices intended to transmit energy, substances or other elements without significant changes are not considered active devices. MDR Art. 2(4)
Active implantable medical device (AIMD)
Any implantable device the operation of which depends on a source of electrical energy or any source of power other than that generated directly by the human body or gravity. MDR Art. 2(5)
Adverse event / Serious incident
See Serious incident.
ARTG
Australian Register of Therapeutic Goods — the Australian equivalent of CE marking; not applicable to EU MDR/IVDR. See What is a medical device? for the EU framework.
Authorised representative (EU REP)
Any natural or legal person established within the EU who has received and accepted a written mandate from a non-EU manufacturer to act on the manufacturer's behalf in relation to specified tasks with regard to the manufacturer's obligations under MDR/IVDR. MDR Art. 2(32) / IVDR Art. 2(29)
C
CE marking
A marking by which the manufacturer indicates that a device conforms with the applicable requirements set out in MDR/IVDR and with other applicable Union harmonisation legislation providing for its affixing. MDR Art. 2(43)
Clinical benefit
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. MDR Art. 2(53)
Clinical data
Information concerning safety or performance that is generated from the use of a device, including: clinical investigations; literature searches; post-market clinical follow-up; and clinical experience from marketed devices. MDR Art. 2(48)
Clinical evaluation
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. MDR Art. 2(44)
Clinical evidence
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. MDR Art. 2(51)
Clinical investigation
Any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device. MDR Art. 2(45)
Companion diagnostic
A device which is essential for the safe and effective use of a corresponding medicinal product to: identify patients who are most likely to benefit from the corresponding medicinal product; identify patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product. IVDR Art. 2(7)
Competent authority (CA)
An authority designated by a Member State under Article 101 MDR (or Article 96 IVDR) responsible for market surveillance, clinical investigation oversight, and notified body designation within that Member State.
Conformity assessment
The process demonstrating whether the requirements of MDR or IVDR relating to a device have been fulfilled. MDR Art. 2(40)
Contract manufacturer
A legal entity that manufactures a device on behalf of another entity (the brand-owner/manufacturer of record) under contract. The contract manufacturer is not the legal manufacturer for MDR/IVDR purposes — the brand-owner who places the device on the market is.
Custom-made device
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. MDR Art. 2(3)
D
Declaration of Conformity (DoC)
A document drawn up by the manufacturer, in which the manufacturer declares that the device concerned conforms with the requirements of MDR or IVDR. MDR Art. 2(42) / IVDR Art. 2(39)
Device
See Medical device or In vitro diagnostic medical device as applicable.
Distributor
Any natural or legal person in the supply chain, other than the manufacturer or importer, who makes a device available on the market until the point of putting into service. MDR Art. 2(34) / IVDR Art. 2(31)
E
Economic operator
A manufacturer, an authorised representative, an importer, or a distributor. MDR Art. 2(35) / IVDR Art. 2(32)
EUDAMED
European Database on Medical Devices — the central EU IT platform for information on medical devices placed on the EU market, including economic operator registration, device registration, UDI data, NB certificates, clinical investigations, vigilance data, and market surveillance. MDR Art. 33
EU declaration of conformity
See Declaration of Conformity (DoC).
F
Field safety corrective action (FSCA)
An action taken by a manufacturer to reduce a risk of death or serious deterioration in the state of health associated with the use of a device that is already placed on the market. Such actions, whether or not initiated by the manufacturer, shall be notified via a field safety notice. MDR Art. 2(68)
Field safety notice (FSN)
A communication sent by a manufacturer or its representative to users in relation to a field safety corrective action. MDR Art. 2(69)
Fully refurbished device
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 MDR, combined with the assignment of a new lifetime to the refurbished device.
G
General safety and performance requirements (GSPR)
The requirements in Annex I of MDR/IVDR that all devices must meet before they can be CE marked. Equivalent to Essential Requirements under the old Directives, but more comprehensive. MDR Annex I / IVDR Annex I
H
Harmonised standard
A European standard adopted by a European standardisation organisation pursuant to a request from the European Commission. Compliance with a harmonised standard provides a presumption of conformity with the corresponding GSPR requirements. MDR Art. 2(71)
Healthcare institution
An organisation, the primary purpose of which is the care or treatment of patients or the promotion of public health. MDR Art. 2(36)
I
Importer
Any natural or legal person established within the EU that places a device from a third country on the EU market. MDR Art. 2(33) / IVDR Art. 2(30)
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 after the procedure. MDR Art. 2(6)
In vitro diagnostic medical device (IVD)
Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body, including blood and tissue donations. IVDR Art. 2(2)
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 and statements, and as specified by the manufacturer in the clinical evaluation. MDR Art. 2(12) / IVDR Art. 2(12)
L
Legacy device
Informal term for a device certified under MDD/AIMDD/IVDD that is in the transitional period before MDR/IVDR compliance is required. See Transitional provisions & timelines.
M
Making available on the market
Any supply of a device, other than an investigational device or device for performance study, for distribution, consumption, or use on the EU market in the course of a commercial activity, whether in return for payment or free of charge. MDR Art. 2(27)
Manufacturer
Any natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured, or fully refurbished, and places that device on the market under its name or trademark, or puts it into service for its own purposes. MDR Art. 2(30) / IVDR Art. 2(27)
Market surveillance
The activities carried out and the measures taken by competent authorities to check and ensure that devices comply with the requirements set out in MDR/IVDR and do not endanger health, safety, or any other aspect of public interest protection. MDR Art. 2(64)
MDCG
Medical Device Coordination Group — the expert body assisting the European Commission and Member States in implementing MDR and IVDR, publishing guidance documents, and coordinating between Member States' competent authorities. MDR Art. 103
Medical device
See What is a medical device? for the full definition and analysis. MDR Art. 2(1)
N
NANDO
New Approach Notified and Designated Organisations — the European Commission's public database listing all notified bodies designated under EU harmonisation legislation, including MDR and IVDR.
Notified body (NB)
A conformity assessment body designated in accordance with MDR/IVDR to carry out third-party conformity assessment activities. MDR Art. 2(38)
P
Performance evaluation (IVDR)
An assessment and analysis of data to establish or verify the scientific validity, the analytical performance and, where applicable, the clinical performance of a device. IVDR Art. 2(44)
Performance study
An investigation of a device intended by the manufacturer to establish or confirm the analytical or clinical performance of a device. IVDR Art. 2(42)
Periodic Safety Update Report (PSUR)
A report that manufacturers of Class IIa, IIb, and III devices (MDR) and Class C and D devices (IVDR) must prepare, summarising the results and conclusions of the analyses of PMS data gathered, together with a rationale and description of any preventive and corrective actions taken. MDR Art. 86 / IVDR Art. 81
Person responsible for regulatory compliance (PRRC)
An individual designated within a manufacturer or EU REP who ensures compliance with the obligations set out in MDR/IVDR. MDR Art. 15 / IVDR Art. 15
Post-market clinical follow-up (PMCF)
A continuous process that updates the clinical evaluation and is addressed in the manufacturer's post-market surveillance plan. PMCF shall be used to confirm the safety and performance throughout the expected lifetime of the device. MDR Annex XIV Part B
Post-market performance follow-up (PMPF)
The IVDR equivalent of PMCF. A continuous process that updates the performance evaluation. IVDR Annex XIII Part B
Post-market surveillance (PMS)
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 placed on the market. MDR Art. 83
Putting into service
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 EU market for the first time for its intended purpose. MDR Art. 2(28)
Q
Quality management system (QMS)
The organisational structure, responsibilities, procedures, processes, and resources needed to implement quality management. For MDR/IVDR, QMS requirements are set out in Art. 10(9). ISO 13485:2016 is the primary standard.
R
Recall
Any measure aimed at achieving the return of a device that has already been made available to the end user. MDR Art. 2(62)
Risk
The combination of the probability of occurrence of harm and the severity of that harm. MDR Art. 2(23); ISO 14971
S
Serious 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, that directly or indirectly led, might have led, or might lead to the death or a temporary or permanent serious deterioration in the state of health of a patient, user, or other person. MDR Art. 2(65)
Single-use device
A device that is intended to be used on one individual during a single procedure. MDR Art. 2(8)
Single Registration Number (SRN)
The unique identifier assigned to an economic operator upon registration in EUDAMED. Required before devices can be registered in EUDAMED.
Specimen receptacle
Any device that is specifically intended by its manufacturer to be used for the primary containment and preservation of specimens derived from the human body for IVD examination. IVDR Art. 2(3)
T
Technical documentation
The documentation that the manufacturer must prepare to demonstrate that a device complies with MDR/IVDR requirements. Specified in MDR Annex II and III / IVDR Annex II and III.
Therapeutic goods
Australian regulatory term — not used in EU MDR/IVDR.
U
Unique Device Identifier (UDI)
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. Comprises the UDI-DI (device identifier) and UDI-PI (production identifier). MDR Art. 2(15)
UDI-DI
The mandatory fixed portion of a UDI that identifies the device model or version.
UDI-PI
The variable portion of a UDI that identifies the individual production unit (e.g. lot, batch, serial number, manufacturing date, expiry date).
V
Vigilance
The post-market system for reporting and investigating serious incidents and field safety corrective actions to competent authorities. MDR Art. 87–92 / IVDR Art. 82–86
W
Withdrawal
Any measure aimed at preventing a device in the supply chain from being further made available on the market. MDR Art. 2(63)
Related pages
Official references
| Reference | Description |
|---|---|
| MDR Art. 2 | Full definitions list (67 defined terms) |
| IVDR Art. 2 | Full definitions list (IVDR) |
| ISO 14971:2019 | Risk management for medical devices |
| ISO 13485:2016 | Medical device QMS |