Abbreviation,Full term,Explanation,Reference,Country,Legislation,Device type,Technical area accessory for a medical device,Accessory for a medical device,"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).",MDR Article 2(2),EU,EU MDR,,Device types accessory for an in vitro diagnostic medical device,Accessory for an in vitro diagnostic medical device,"An article which, whilst not being itself an in vitro diagnostic medical device, is intended by its manufacturer to be used together with one or several particular in vitro diagnostic medical device(s) to specifically enable the in vitro diagnostic 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 in vitro diagnostic medical device(s) in terms of its/their intended purpose(s).",IVDR Article 2(4),EU,EU IVDR,IVD,Device types active device,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 changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices. Software shall also be deemed to be an active device.",MDR Article 2(4),EU,EU MDR,,Device types adverse event,Adverse event,"Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device. Under the IVDR: any untoward medical occurrence, inappropriate patient management decision, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a performance study, whether or not related to the device for performance study.",MDR Article 2(57); IVDR Article 2(60),EU,EU MDR; EU IVDR,,Vigilance agglomerate,Agglomerate,"For the purposes of the definition of nanomaterial in point (18), a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components.",MDR Article 2(20),EU,EU MDR,,Materials aggregate,Aggregate,"For the purposes of the definition of nanomaterial in point (18), a particle comprising of strongly bound or fused particles.",MDR Article 2(21),EU,EU MDR,,Materials AIDC,Automatic identification and data capture,"A technology used to automatically capture data. AIDC technologies include bar codes, smart cards, biometrics and RFID.",MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1,EU,EU MDR; EU IVDR,,Traceability AIMDD,Active Implantable Medical Devices Directive 90/385/EEC,"The directive that governed active implantable devices such as pacemakers and implantable defibrillators before the MDR, repealed by the MDR subject to transitional provisions.",MDR Article 122,EU,EU MDR,Implantable,Transition analytical performance,Analytical performance,The ability of a device to correctly detect or measure a particular analyte.,IVDR Article 2(40),EU,EU IVDR,IVD,Performance Annex XVI products,Products without an intended medical purpose,"Groups of products brought within the MDR despite having no medical purpose, including coloured contact lenses, products for liposuction or lipoplasty, dermal fillers, equipment for high-intensity electromagnetic radiation such as lasers used cosmetically, and brain stimulation equipment.",MDR Article 1(2) and Annex XVI,EU,EU MDR,,Device types authorised representative,Authorised representative,"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.",MDR Article 2(32); IVDR Article 2(25),EU,EU MDR; EU IVDR,,Economic operators Basic UDI-DI,Basic UDI device identifier,The primary identifier of a device model. It is the DI assigned at the level of the device unit of use. It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity.,MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1,EU,EU MDR; EU IVDR,,Traceability benefit-risk determination,Benefit-risk determination,"The analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose, when used in accordance with the intended purpose given by the manufacturer.",MDR Article 2(24); IVDR Article 2(17),EU,EU MDR; EU IVDR,,Risk Borderline product,Borderline product,"A product whose regulatory status is unclear — whether it is a device, a medicinal product, a cosmetic, a biocide or something else. Member States may ask the Commission to determine the status of a specific product or group of products by implementing act, after consulting the MDCG.",MDR Article 4; IVDR Article 3,EU,EU MDR; EU IVDR,,Market access BtX,Breakthrough device,"A device introducing a high degree of novelty in its technology, the related clinical procedure, or its application in clinical practice, and expected to deliver a significant positive clinical impact for a life-threatening or irreversibly debilitating disease — either against available alternatives and the state of the art, or by meeting an unmet medical need. A guidance concept rather than a defined legal status.",MDCG 2025-9,EU,EU MDR,,Device types CA,Competent authority,"The national authority designated by a Member State to apply the regulations: designating and monitoring notified bodies, running market surveillance and vigilance, and authorising clinical investigations or performance studies. Each Member State has its own, and they act independently of one another.",MDR Article 101; IVDR Article 96,EU,EU MDR; EU IVDR,,Conformity assessment calibrator,Calibrator,A measurement reference material used in the calibration of a device.,IVDR Article 2(55),EU,EU IVDR,IVD,Device types CAPA,Corrective and preventive action,"The quality system process for investigating problems, eliminating their causes and preventing recurrence. Corrective action is defined in both regulations; the combined CAPA term comes from quality management practice rather than from the regulations themselves.",MDR Article 2(67); IVDR Article 2(70),EU,EU MDR; EU IVDR,,Quality system CDP,Clinical development plan,"The part of the clinical evaluation plan setting out the progression of clinical investigations, from exploratory work such as first-in-human or feasibility studies through to confirmatory investigations, together with the milestones and acceptance criteria along the way.",MDR Annex XIV Part A point 1(a),EU,EU MDR,,Clinical CE marking,CE marking of conformity,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.,MDR Article 2(43); IVDR Article 2(35),EU,EU MDR; EU IVDR,,Conformity assessment CEAR,Clinical evaluation assessment report,"The notified body’s written assessment of a manufacturer’s clinical evaluation, produced during conformity assessment. Deficiencies raised in it are a common cause of delay to certification.",MDR Article 61(7),EU,EU MDR,,Conformity assessment CECP,Clinical evaluation consultation procedure,"The additional scrutiny applied to certain class III implantable devices and class IIb active devices intended to administer or remove a medicinal product, in which an expert panel may review the notified body’s assessment of the clinical evaluation before certification.",MDR Article 54 and Annex IX Section 5.1,EU,EU MDR,,Conformity assessment CEP,Clinical evaluation plan,"The plan that sets out how the clinical evaluation will be conducted before it starts: the intended purpose and claims, the general safety and performance requirements needing clinical evidence, the clinical benefits and outcome parameters, and the methods for appraising the data.",MDR Annex XIV Part A point 1(a),EU,EU MDR,,Clinical CER,Clinical evaluation report,"The document recording the results of the clinical evaluation and the clinical evidence it rests on. It supports the conformity assessment of the device, forms part of the technical documentation, and must be updated throughout the device lifetime with data from post-market clinical follow-up.",MDR Article 61(12) and Annex XIV Part A point 4,EU,EU MDR,,Clinical Certificate of conformity,Certificates of conformity,"The certificates issued by a notified body when a device or quality management system passes conformity assessment. Validity is capped at five years, and certificates may be suspended, restricted or withdrawn where requirements are no longer met.",MDR Article 56 and Annex XII,EU,EU MDR,,Conformity assessment Certificate of free sale,Certificate of free sale,"A certificate issued by a Member State, at the manufacturer’s request, confirming that a device may lawfully be sold in the Union. Typically requested to support registration in export markets.",MDR Article 60,EU,EU MDR,,Market access Classification,Classification of devices,"The rules that assign a device to a risk class, which then determines the conformity assessment route and the level of notified body involvement. Under the MDR devices fall into classes I, IIa, IIb and III according to the rules in Annex VIII. Under the IVDR devices fall into classes A, B, C and D under a different Annex VIII rule set.",MDR Article 51 and Annex VIII; IVDR Article 47 and Annex VIII,EU,EU MDR; EU IVDR,,Classification clinical benefit,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. Under the IVDR: the positive impact of a device related to its function, such as that of screening, monitoring, diagnosis or aid to diagnosis of patients, or a positive impact on patient management or public health.",MDR Article 2(53); IVDR Article 2(37),EU,EU MDR; EU IVDR,,Clinical clinical data,Clinical data,"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.",MDR Article 2(48),EU,EU MDR,,Clinical clinical evaluation,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 Article 2(44),EU,EU MDR,,Clinical clinical evidence,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. Under the IVDR: clinical data and performance 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 Article 2(51); IVDR Article 2(36),EU,EU MDR; EU IVDR,,Clinical clinical investigation,Clinical investigation,"Any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device.",MDR Article 2(45),EU,EU MDR,,Clinical clinical investigation plan,Clinical investigation plan,"A document that describes the rationale, objectives, design, methodology, monitoring, statistical considerations, organisation and conduct of a clinical investigation.",MDR Article 2(47),EU,EU MDR,,Clinical clinical performance,Clinical performance,"The ability of a device, resulting from any direct or indirect medical effects which stem from its technical or functional characteristics, including diagnostic characteristics, to achieve its intended purpose as claimed by the manufacturer, thereby leading to a clinical benefit for patients, when used as intended by the manufacturer. Under the IVDR: 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.",MDR Article 2(52); IVDR Article 2(41),EU,EU MDR; EU IVDR,,Clinical companion diagnostic,Companion diagnostic,"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.",IVDR Article 2(7),EU,EU IVDR,IVD,Device types compatibility,Compatibility,"The ability of a device, including software, when used together with one or more other devices in accordance with its intended purpose, to: (a) perform without losing or compromising the ability to perform as intended, and/or (b) integrate and/or operate without the need for modification or adaption of any part of the combined devices, and/or (c) be used together without conflict/interference or adverse reaction.",MDR Article 2(25); IVDR Article 2(18),EU,EU MDR; EU IVDR,,Performance configurable device,Configurable device,"A device that consists of several components which can be assembled by the manufacturer in multiple configurations. Those individual components may be devices in themselves. Configurable devices include computed tomography (CT) systems, ultrasound systems, anaesthesia systems, physiological Monitoring systems, radiology information systems (RIS).",MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1,EU,EU MDR; EU IVDR,,Traceability configuration,Configuration,"A combination of items of equipment, as specified by the manufacturer, that operate together as a device to achieve an intended purpose. The combination of items may be modified, adjusted or customized to meet specific needs. Configurations include inter alia: — gantries, tubes, tables, consoles and other items of equipment that can be configured/combined to deliver an intended function in computed tomography. — ventilators, breathing circuits, vaporizers combined to deliver an intended function in anaesthesia.",MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1,EU,EU MDR; EU IVDR,,Traceability conformity assessment,Conformity assessment,The process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled.,MDR Article 2(40); IVDR Article 2(32),EU,EU MDR; EU IVDR,,Conformity assessment conformity assessment body,Conformity assessment body,"A body that performs third-party conformity assessment activities including calibration, testing, certification and inspection.",MDR Article 2(41); IVDR Article 2(33),EU,EU MDR; EU IVDR,,Conformity assessment Conformity assessment procedure,Conformity assessment procedure,"The route a manufacturer takes to demonstrate compliance, chosen according to the device’s classification. Routes combine quality management system assessment, technical documentation assessment and, for some devices, type-examination or product verification.",MDR Article 52 and Annexes IX to XI; IVDR Article 48 and Annexes IX to XI,EU,EU MDR; EU IVDR,,Conformity assessment control material,Control material,"A substance, material or article intended by its manufacturer to be used to verify the performance characteristics of a device.",IVDR Article 2(56),EU,EU IVDR,IVD,Device types corrective action,Corrective action,Action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation.,MDR Article 2(67); IVDR Article 2(70),EU,EU MDR; EU IVDR,,Vigilance CS,Common specifications,"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.",MDR Article 2(71); IVDR Article 2(74),EU,EU MDR; EU IVDR,,Conformity assessment custom-made device,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. 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.",MDR Article 2(3),EU,EU MDR,,Device types derivative,Derivative,A ‘non-cellular substance’ extracted from human or animal tissue or cells through a manufacturing process. The final substance used for manufacturing of the device in this case does not contain any cells or tissues.,MDR Article 2(17),EU,EU MDR,,Materials device deficiency,Device deficiency,"Any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in information supplied by the manufacturer. Under the IVDR: any inadequacy in the identity, quality, durability, reliability, safety or performance of a device for performance study, including malfunction, use errors or inadequacy in information supplied by the manufacturer.",MDR Article 2(59); IVDR Article 2(62),EU,EU MDR; EU IVDR,,Vigilance device for near-patient testing,Device for near-patient testing,"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.",IVDR Article 2(6),EU,EU IVDR,IVD,Device types device for performance study,Device for performance study,"A device intended by the manufacturer to be used in a performance study. A device intended to be used for research purposes, without any medical objective, shall not be deemed to be a device for performance study.",IVDR Article 2(45),EU,EU IVDR,IVD,Device types device for self-testing,Device for self-testing,"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.",IVDR Article 2(5),EU,EU IVDR,IVD,Device types diagnostic sensitivity,Diagnostic sensitivity,The ability of a device to identify the presence of a target marker associated with a particular disease or condition.,IVDR Article 2(50),EU,EU IVDR,IVD,Performance diagnostic specificity,Diagnostic specificity,The ability of a device to recognise the absence of a target marker associated with a particular disease or condition.,IVDR Article 2(49),EU,EU IVDR,IVD,Performance Distance sales,Distance sales,"Devices offered through information society services to a person in the Union must comply with the regulation. This extends to devices not placed on the market but used to provide a diagnostic or therapeutic service remotely, and a copy of the declaration of conformity must be made available on request.",MDR Article 6; IVDR Article 6,EU,EU MDR; EU IVDR,,Market access distributor,Distributor,"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.",MDR Article 2(34); IVDR Article 2(27),EU,EU MDR; EU IVDR,,Economic operators DoC,EU declaration of conformity,"The manufacturer’s signed statement that a device meets the applicable requirements. It must be kept up to date, translated into the languages required by the Member States where the device is made available, and its minimum content is fixed by Annex IV.",MDR Article 19 and Annex IV; IVDR Article 17 and Annex IV,EU,EU MDR; EU IVDR,,Conformity assessment economic operator,Economic operator,"A manufacturer, an authorised representative, an importer, a distributor or the person referred to in Article 22(1) and 22(3). Under the IVDR: a manufacturer, an authorised representative, an importer or a distributor.",MDR Article 2(35); IVDR Article 2(28),EU,EU MDR; EU IVDR,,Economic operators eIFU,Electronic instructions for use,"Instructions supplied in non-paper form rather than on paper. Permitted only to the extent and under the conditions set by the regulation and the Commission implementing regulation on electronic instructions for use, which restricts which devices qualify and requires paper copies to remain available on request.",MDR Annex I Section 23.1(f),EU,EU MDR,,Labelling EMDN,European Medical Device Nomenclature,The nomenclature used to describe and categorise devices in Eudamed. The regulations require an internationally recognised nomenclature to be made available free of charge; the EMDN is the system the Commission designated for that purpose.,MDR Article 26; IVDR Article 23,EU,EU MDR; EU IVDR,,Registration Equivalence,Equivalence,"The basis on which clinical data relating to another device may be used to support a clinical evaluation, provided technical, biological and clinical characteristics are sufficiently similar that no clinically significant difference in safety or performance results. The manufacturer must also demonstrate sufficient access to the other device’s data.",MDR Annex XIV Part A point 3; MDCG 2020-5,EU,EU MDR,,Clinical ethics committee,Ethics committee,"An independent body established in a Member State in accordance with the law of that Member State and empowered to give opinions for the purposes of this Regulation, taking into account the views of laypersons, in particular patients or patients' organisations.",MDR Article 2(56); IVDR Article 2(59),EU,EU MDR; EU IVDR,,Clinical EUDAMED,European database on medical devices,"The Commission-run database bringing together registration of devices and economic operators, the UDI database, notified bodies and certificates, clinical investigations or performance studies, vigilance and post-market surveillance, and market surveillance. Parts of it are public.",MDR Article 33; IVDR Article 30,EU,EU MDR; EU IVDR,,Registration EURL,European Union reference laboratory,"A laboratory designated under the IVDR to verify the performance of class D devices and check batches, and to provide scientific and technical assistance to the Commission and Member States. There is no direct MDR equivalent.",IVDR Article 100,EU,EU IVDR,IVD,Conformity assessment Expert panel,Expert panel,"A body of independent experts appointed to give scientific, technical and clinical opinions, including views on clinical evaluation under the consultation procedure and on common specifications.",MDR Article 106,EU,EU MDR,,Conformity assessment falsified device,Falsified device,Any device with a false presentation of its identity and/or of its source and/or its CE marking certificates or documents relating to CE marking procedures. This definition does not include unintentional non-compliance and is without prejudice to infringements of intellectual property rights.,MDR Article 2(9); IVDR Article 2(10),EU,EU MDR; EU IVDR,,Device types field safety corrective action,Field safety corrective action,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.,MDR Article 2(68); IVDR Article 2(71),EU,EU MDR; EU IVDR,,Vigilance field safety notice,Field safety notice,A communication sent by a manufacturer to users or customers in relation to a field safety corrective action.,MDR Article 2(69); IVDR Article 2(72),EU,EU MDR; EU IVDR,,Vigilance fully refurbishing,Fully refurbishing,"For the purposes of the definition of manufacturer, 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 this Regulation, combined with the assignment of a new lifetime to the refurbished device.",MDR Article 2(31); IVDR Article 2(24),EU,EU MDR; EU IVDR,,Economic operators Gap assessment,Gap assessment,"A structured comparison of existing technical documentation and processes against the requirements that now apply, producing a list of what must change. An industry practice rather than a regulatory requirement, most often run when moving a device from the directives to the regulations.",,EU,EU MDR; EU IVDR,,Transition generic device group,Generic device group,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.,MDR Article 2(7); IVDR Article 2(8),EU,EU MDR; EU IVDR,,Device types Grandfathering,Grandfathering,"Carrying a device’s existing approval forward into a new regulatory framework without reassessment. The MDR contains no such mechanism: devices certified under the directives must be assessed against the regulation, with the transitional provisions governing only how long the old certificates remain valid.",,EU,EU MDR,,Transition GSPR,General safety and performance requirements,"The set of requirements every device must meet before it can be CE marked, covering general safety, design and manufacture, and the information supplied with the device. Compliance is demonstrated requirement by requirement, and the evidence sits in the technical documentation. Requirements that do not apply to a given device must be justified rather than ignored.",MDR Annex I; IVDR Annex I,EU,EU MDR; EU IVDR,,Technical documentation harmonised standard,Harmonised standard,A European standard as defined in point (1)(c) of Article 2 of Regulation (EU) No 1025/2012.,MDR Article 2(70); IVDR Article 2(73),EU,EU MDR; EU IVDR,,Conformity assessment health institution,Health institution,An organisation the primary purpose of which is the care or treatment of patients or the promotion of public health.,MDR Article 2(36); IVDR Article 2(29),EU,EU MDR; EU IVDR,,Economic operators 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.",MDR Article 5(5); IVDR Article 5(5),EU,EU MDR; EU IVDR,,Market access HRI,Human readable interpretation,A legible interpretation of the data characters encoded in the UDI carrier.,MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1,EU,EU MDR; EU IVDR,,Traceability 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.",,EU,EU MDR; EU IVDR,,Conformity assessment Implant card,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.",MDR Article 18,EU,EU MDR,Implantable,Labelling implantable device,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.",MDR Article 2(5),EU,EU MDR,Implantable,Device types importer,Importer,Any natural or legal person established within the Union that places a device from a third country on the Union market.,MDR Article 2(33); IVDR Article 2(26),EU,EU MDR; EU IVDR,,Economic operators in vitro diagnostic medical device,In vitro diagnostic medical device,"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.",IVDR Article 2(2),EU,EU IVDR,IVD,Device types incident,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.",MDR Article 2(64); IVDR Article 2(67),EU,EU MDR; EU IVDR,,Vigilance 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.",MDCG 2020-6,EU,EU MDR,,Performance informed consent,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.",MDR Article 2(55); IVDR Article 2(58),EU,EU MDR; EU IVDR,,Clinical instructions for use,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.,MDR Article 2(14); IVDR Article 2(14),EU,EU MDR; EU IVDR,,Labelling intended purpose,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.",MDR Article 2(12); IVDR Article 2(12),EU,EU MDR; EU IVDR,,Performance Intended use,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.",MDCG 2020-6,EU,EU MDR,,Performance interoperability,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.",MDR Article 2(26); IVDR Article 2(19),EU,EU MDR; EU IVDR,,Performance interventional clinical performance study,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.,IVDR Article 2(46),EU,EU IVDR,IVD,Clinical invasive device,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.",MDR Article 2(6),EU,EU MDR,,Device types investigational device,Investigational device,A device that is assessed in a clinical investigation.,MDR Article 2(46),EU,EU MDR,,Device types investigator,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.,MDR Article 2(54); IVDR Article 2(48),EU,EU MDR; EU IVDR,,Clinical kit,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.",IVDR Article 2(11),EU,EU IVDR,IVD,Device types label,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.",MDR Article 2(13); IVDR Article 2(13),EU,EU MDR; EU IVDR,,Labelling lay person,Lay person,An individual who does not have formal education in a relevant field of healthcare or medical discipline.,MDR Article 2(38); IVDR Article 2(31),EU,EU MDR; EU IVDR,,Economic operators 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.",IVDR Article 5(5),EU,EU IVDR,IVD,Market access Legacy device,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.",MDCG 2020-6,EU,EU MDR,,Transition likelihood ratio,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.,IVDR Article 2(54),EU,EU IVDR,IVD,Performance making available on the market,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.",MDR Article 2(27); IVDR Article 2(20),EU,EU MDR; EU IVDR,,Market access manufacturer,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.",MDR Article 2(30); IVDR Article 2(23),EU,EU MDR; EU IVDR,,Economic operators market surveillance,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.",MDR Article 2(61); IVDR Article 2(64),EU,EU MDR; EU IVDR,,Post-market 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.",,EU,EU MDR,,Clinical MDCG,Medical Device Coordination Group,"The group of Member State experts that advises and assists the Commission, issues guidance on the application of both regulations, and contributes to notified body designation and scrutiny. Its guidance documents are not legally binding.",MDR Article 103,EU,EU MDR,,Conformity assessment MDD,Medical Devices Directive 93/42/EEC,"The directive that governed most medical devices in the EU before the MDR, repealed by the MDR subject to transitional provisions. Devices certified under it are referred to in guidance as legacy devices.",MDR Article 122,EU,EU MDR,,Transition 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.",MDCG 2019-11,EU,EU MDR; EU IVDR,Software,Device types MEDDEV,MEDDEV guidance,"The series of European consensus guidance documents produced under the directives, of which MEDDEV 2.7/1 revision 4 on clinical evaluation is the most used. Not legally binding and not written for the MDR, but still referenced in practice where MDCG guidance has not replaced it.",,EU,EU MDR,,Clinical medical device,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. Under the IVDR: ‘medical device’ as defined in point (1) of Article 2 of Regulation (EU) 2017/745.",MDR Article 2(1); IVDR Article 2(1),EU,EU MDR; EU IVDR,,Device types 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.",MDR Article 87; IVDR Article 82,EU,EU MDR; EU IVDR,,Vigilance 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.",MDR Article 42; IVDR Article 38,EU,EU MDR; EU IVDR,,Conformity assessment nanomaterial,Nanomaterial,"A natural, incidental or manufactured material containing particles in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm; Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall also be deemed to be nanomaterials.",MDR Article 2(18),EU,EU MDR,,Materials negative predictive value,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.,IVDR Article 2(53),EU,EU IVDR,IVD,Performance non-viable,Non-viable,Having no potential for metabolism or multiplication.,MDR Article 2(16),EU,EU MDR,,Materials notified body,Notified body,A conformity assessment body designated in accordance with this Regulation.,MDR Article 2(42); IVDR Article 2(34),EU,EU MDR; EU IVDR,,Conformity assessment 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.",MDR Article 16(1)(a); IVDR Article 16(1)(a),EU,EU MDR; EU IVDR,,Economic operators Orphan device,Orphan device,"A device specifically intended to benefit patients with a disease or condition presenting in no more than 12,000 individuals in the EU per year, where there is an insufficiency of available alternatives or where clinical data cannot reasonably be generated in the usual way. A guidance concept affecting the clinical evidence expected.",MDCG 2024-10,EU,EU MDR,,Device types packaging levels,Packaging levels,"The various levels of device packaging that contain a defined quantity of devices, such as a carton or case.",MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1,EU,EU MDR; EU IVDR,,Traceability particle,Particle,"For the purposes of the definition of nanomaterial in point (18), a minute piece of matter with defined physical boundaries.",MDR Article 2(19),EU,EU MDR,,Materials 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.",IVDR Annex XIII Part A point 1.1,EU,EU IVDR,IVD,Clinical 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.",IVDR Annex XIII Part A point 1.3.2,EU,EU IVDR,IVD,Clinical performance,Performance,The ability of a device to achieve its intended purpose as stated by the manufacturer.,MDR Article 2(22),EU,EU MDR,,Performance performance evaluation,Performance evaluation,"An assessment and analysis of data to establish or verify the scientific validity, the analytical and, where applicable, the clinical performance of a device.",IVDR Article 2(44),EU,EU IVDR,IVD,Clinical performance of a device,Performance of a device,"The ability of a device to achieve its intended purpose as claimed by the manufacturer. It consists of the analytical and, where applicable, the clinical performance supporting that intended purpose.",IVDR Article 2(39),EU,EU IVDR,IVD,Performance performance study,Performance study,A study undertaken to establish or confirm the analytical or clinical performance of a device.,IVDR Article 2(42),EU,EU IVDR,IVD,Clinical performance study plan,Performance study plan,"A document that describes the rationale, objectives, design methodology, monitoring, statistical considerations, organisation and conduct of a performance study.",IVDR Article 2(43),EU,EU IVDR,IVD,Clinical placing on the market,Placing on the market,"The first making available of a device, other than an investigational device, on the Union market. Under the IVDR: the first making available of a device, other than a device for performance study, on the Union market.",MDR Article 2(28); IVDR Article 2(21),EU,EU MDR; EU IVDR,,Market access PMCF,Post-market clinical follow-up,"The continuous process of proactively collecting and evaluating clinical data from a device already on the market, in order to confirm safety and performance across its expected lifetime, identify previously unknown side effects, and check that the benefit-risk position still holds. It is a planned activity, not a reaction to complaints.",MDR Annex XIV Part B,EU,EU MDR,,Post-market PMCF evaluation report,Post-market clinical follow-up evaluation report,"The manufacturer’s analysis of the findings of PMCF activities. It forms part of both the clinical evaluation report and the technical documentation, and its conclusions feed back into the clinical evaluation and the benefit-risk determination.",MDR Annex XIV Part B point 7,EU,EU MDR,,Post-market PMCF plan,Post-market clinical follow-up plan,"The document specifying the methods, rationale and time schedule for PMCF activities, including the general and specific methods to be used, references to the relevant parts of the clinical evaluation report, and the objectives the activities are meant to address.",MDR Annex XIV Part B point 6,EU,EU MDR,,Post-market PMPF,Post-market performance follow-up,"The IVDR counterpart to PMCF: a continuous process of updating the performance evaluation using data gathered from the device in routine use, addressed in a PMPF plan and reported in a PMPF evaluation report that forms part of the performance evaluation report.",IVDR Annex XIII Part B,EU,EU IVDR,IVD,Post-market PMS plan,Post-market surveillance plan,"The plan describing how the manufacturer will collect and analyse experience from devices on the market, what indicators and thresholds will be used, and how complaints, trends and field data feed into corrective action. It forms part of the technical documentation.",MDR Article 84 and Annex III; IVDR Article 79 and Annex III,EU,EU MDR; EU IVDR,,Post-market PMS report,Post-market surveillance report,"The lighter-touch reporting route for lower-risk devices, summarising the results and conclusions of post-market surveillance together with any preventive and corrective actions taken. It is updated as necessary and made available to authorities on request rather than routinely submitted.",MDR Article 85; IVDR Article 80,EU,EU MDR; EU IVDR,,Post-market positive predictive value,Positive predictive value,The ability of a device to separate true positive results from false positive results for a given attribute in a given population.,IVDR Article 2(52),EU,EU IVDR,IVD,Performance post-market surveillance,Post-market surveillance,"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.",MDR Article 2(60); IVDR Article 2(63),EU,EU MDR; EU IVDR,,Post-market predictive value,Predictive value,"The probability that a person with a positive device test result has a given condition under investigation, or that a person with a negative device test result does not have a given condition.",IVDR Article 2(51),EU,EU IVDR,IVD,Performance procedure pack,Procedure pack,A combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose.,MDR Article 2(10),EU,EU MDR,,Device types PRRC,Person responsible for regulatory compliance,"The individual a manufacturer must have available with defined qualifications or experience, responsible for release checks, technical documentation and the declaration of conformity, post-market surveillance obligations and vigilance reporting. Micro and small enterprises need not employ the person directly but must have one permanently at their disposal.",MDR Article 15; IVDR Article 15,EU,EU MDR; EU IVDR,,Economic operators PSUR,Periodic safety update report,"The recurring post-market report required for higher-risk devices, summarising surveillance findings, the conclusions of the benefit-risk determination, the main findings of post-market follow-up, and sales volume with an estimate of the population using the device. Update frequency depends on risk class.",MDR Article 86; IVDR Article 81,EU,EU MDR; EU IVDR,,Post-market putting into service,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 Union market for the first time for its intended purpose. Under the IVDR: the stage at which a device, other than a device for performance study, 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.",MDR Article 2(29); IVDR Article 2(22),EU,EU MDR; EU IVDR,,Market access QMS,Quality management system,"The documented system through which a manufacturer ensures ongoing compliance, proportionate to risk class and device type. The regulation lists the aspects it must cover, including regulatory compliance strategy, risk management, clinical evaluation or performance evaluation, product realisation, post-market surveillance and vigilance.",MDR Article 10(9); IVDR Article 10(8),EU,EU MDR; EU IVDR,,Quality system recall,Recall,Any measure aimed at achieving the return of a device that has already been made available to the end user.,MDR Article 2(62); IVDR Article 2(65),EU,EU MDR; EU IVDR,,Vigilance reprocessing,Reprocessing,"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.",MDR Article 2(39),EU,EU MDR,,Economic operators reprocessing of single-use devices,Reprocessing of single-use devices,"The process applied to a used device to allow safe reuse, permitted only where national law allows it and only in accordance with the regulation and the relevant common specifications. Anyone reprocessing a single-use device is treated as the manufacturer of the reprocessed device.",MDR Article 17,EU,EU MDR,,Economic operators RFID,Radio frequency identification,"A technology that uses communication through the use of radio waves to exchange data between a reader and an electronic tag attached to an object, for the purpose of identification.",MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1,EU,EU MDR; EU IVDR,,Traceability risk,Risk,The combination of the probability of occurrence of harm and the severity of that harm.,MDR Article 2(23); IVDR Article 2(16),EU,EU MDR; EU IVDR,,Risk Risk management,Risk management,"The continuous iterative process, run across the whole device lifecycle, of identifying hazards, estimating and evaluating risks, controlling them and monitoring the effectiveness of those controls. It must be established, documented, implemented and maintained, and updated with production and post-market information.",MDR Article 10(2) and Annex I Section 3; IVDR Article 10(2) and Annex I Section 3,EU,EU MDR; EU IVDR,,Risk RUO,Research use only,"A product not intended for in vitro diagnostic examination and therefore outside the IVDR, unless the manufacturer specifically intends it for diagnostic use in view of its characteristics. Labelling a product research use only does not exempt it if its intended purpose is diagnostic.",IVDR Article 1(3)(a),EU,EU IVDR,IVD,Market access SaMD,Software as a medical device,"The international term for software intended for a medical purpose that performs that purpose without being part of a hardware medical device. Broadly parallel to medical device software in EU guidance, but the definitions are not interchangeable and the EU term should be used in EU submissions.",IMDRF SaMD WG N41,EU,EU MDR; EU IVDR,Software,Device types Scientific validity,Scientific validity,"Used in the MDR in relation to how clinical data is planned, evaluated and concluded upon, without being defined there. Guidance treats it as covering adequacy of study design, control of bias, relevance of the research question, and the soundness of the methodology used to reach conclusions. Distinct from the IVDR term scientific validity of an analyte, which is defined and means something narrower.",MDCG 2020-6,EU,EU MDR,,Clinical scientific validity of an analyte,Scientific validity of an analyte,The association of an analyte with a clinical condition or a physiological state.,IVDR Article 2(38),EU,EU IVDR,IVD,Performance Scientific validity report,Scientific validity report,The report demonstrating the association between an analyte and the clinical condition or physiological state it is intended to identify. It is one of the three inputs the manufacturer assesses when establishing clinical evidence for an IVD.,IVDR Annex XIII Part A points 1.2.1 and 1.3.1,EU,EU IVDR,IVD,Clinical serious adverse event,Serious adverse event,"Any adverse event that led to any of the following: (a) death, (b) serious deterioration in the health of the subject, that resulted in any of the following: (i) life-threatening illness or injury, (ii) permanent impairment of a body structure or a body function, (iii) hospitalisation or prolongation of patient hospitalisation, (iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, (v) chronic disease, (c) foetal distress, foetal death or a congenital physical or mental impairment or birth defect. Under the IVDR: any adverse event that led to any of the following: (a) a patient management decision resulting in death or an imminent life-threatening situation for the individual being tested, or in the death of the individual's offspring, (b) death, (c) serious deterioration in the health of the individual being tested or the recipient of tested donations or materials, that resulted in any of the following: (i) life-threatening illness or injury, (ii) permanent impairment of a body structure or a body function, (iii) hospitalisation or prolongation of patient hospitalisation, (iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, (v) chronic disease, (d) foetal distress, foetal death or a congenital physical or mental impairment or birth defect.",MDR Article 2(58); IVDR Article 2(61),EU,EU MDR; EU IVDR,,Vigilance serious incident,Serious incident,"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.",MDR Article 2(65); IVDR Article 2(68),EU,EU MDR; EU IVDR,,Vigilance serious public health threat,Serious public health threat,"An event which could result in imminent risk of death, serious deterioration in a person's state of health, or serious illness, that may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time.",MDR Article 2(66); IVDR Article 2(69),EU,EU MDR; EU IVDR,,Vigilance shipping container,Shipping container,A container in relation to which traceability is controlled by a process specific to logistics systems.,MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1,EU,EU MDR; EU IVDR,,Traceability Similar device,Similar device,"A device in the same generic device group as the subject device. Similarity supports contextual understanding, such as state of the art or safety and performance objectives, but it is not equivalence and does not permit another device’s clinical data to be used as if it were the subject device’s.",MDCG 2020-6,EU,EU MDR,,Clinical single-use device,Single-use device,A device that is intended to be used on one individual during a single procedure. Under the IVDR: a device that is intended to be used during a single procedure.,MDR Article 2(8); IVDR Article 2(9),EU,EU MDR; EU IVDR,,Device types SOTA,State of the art,"The developed stage of current technical capability and accepted clinical practice for a product, process or approach to patient management, based on consolidated findings of science, technology and experience. It is what is generally accepted as good practice now, not necessarily the most advanced technology available.",MDCG 2020-6; IMDRF GRRP WG N47,EU,EU MDR,,Clinical specimen receptacle,Specimen receptacle,"A device, whether of a vacuum-type or not, specifically intended by its manufacturer for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.",IVDR Article 2(3),EU,EU IVDR,IVD,Device types sponsor,Sponsor,"Any individual, company, institution or organisation which takes responsibility for the initiation, for the management and setting up of the financing of the clinical investigation. Under the IVDR: any individual, company, institution or organisation which takes responsibility for the initiation, for the management and setting up of the financing of the performance study.",MDR Article 2(49); IVDR Article 2(57),EU,EU MDR; EU IVDR,,Clinical SRN,Single registration number,"The identifier issued by a competent authority to a manufacturer, authorised representative or importer once its registration data has been verified. It is used when applying to a notified body and when accessing Eudamed.",MDR Article 31(2); IVDR Article 28(2),EU,EU MDR; EU IVDR,,Registration SSCP,Summary of safety and clinical performance,"A public-facing summary required for implantable and class III devices, other than custom-made or investigational devices. It is written for the intended user and, where relevant, the patient, is validated by the notified body during conformity assessment, and is published in Eudamed. The equivalent under the IVDR is the summary of safety and performance.",MDR Article 32,EU,EU MDR,,Clinical SSP,Summary of safety and performance,"The IVDR counterpart to the SSCP, required for class C and class D devices other than devices for performance studies. It is validated by the notified body, uploaded to Eudamed, and its location must be stated on the label or in the instructions for use.",IVDR Article 29,EU,EU IVDR,IVD,Clinical subject,Subject,An individual who participates in a clinical investigation. Under the IVDR: an individual who participates in a performance study and whose specimen(s) undergo in vitro examination by a device for performance study and/or by a device used for control purposes.,MDR Article 2(50); IVDR Article 2(47),EU,EU MDR; EU IVDR,,Clinical system,System,"A combination of products, either packaged together or not, which are intended to be interconnected or combined to achieve a specific medical purpose.",MDR Article 2(11),EU,EU MDR,,Device types TD,Technical documentation,"The manufacturer’s evidence file showing that a device meets the applicable requirements. Its contents are prescribed rather than optional: device description, design and manufacturing information, evidence against the general safety and performance requirements, risk management, verification and validation, and post-market surveillance documentation.",MDR Article 10(4) and Annexes II and III; IVDR Article 10(4) and Annexes II and III,EU,EU MDR; EU IVDR,,Technical documentation Trend reporting,Trend reporting,"The obligation to report any statistically significant increase in the frequency or severity of incidents that are not themselves serious, or of expected undesirable side-effects, where that increase could materially affect the benefit-risk determination.",MDR Article 88; IVDR Article 83,EU,EU MDR; EU IVDR,,Vigilance UDI,Unique Device Identifier,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.,MDR Article 2(15); IVDR Article 2(15),EU,EU MDR; EU IVDR,,Traceability UDI carrier,UDI carrier,"The means of conveying the UDI by using AIDC and, if applicable, its HRI. UDI carriers include, inter alia, ID/linear bar code, 2D/Matrix bar code, RFID. 2. General requirements 2.1. The affixing of the UDI is an additional requirement — it does not replace any other marking or labelling requirements laid down in Annex I to this Regulation. 2.2. The manufacturer shall assign and maintain unique UDIs for its devices. 2.3. Only the manufacturer may place the UDI on the device or its packaging. 2.4. Only coding standards provided by issuing entities designated by the Commission pursuant to Article 27(2) may be used. 3. The UDI 3.1. A UDI shall be assigned to the device itself or its packaging. Higher levels of packaging shall have their own UDI. 3.2. Shipping containers shall be exempted from the requirement in Section 3.1. By way of example, a UDI shall not be required on a logistics unit; where a healthcare provider orders multiple devices using the UDI or model number of individual devices and the manufacturer places those devices in a container for shipping or to protect the individually packaged devices, the container (logistics unit) shall not be subject to UDI requirements. 3.3. The UDI shall contain two parts: a UDI-DI and a UDI-PI. 3.4. The UDI-DI shall be unique at each level of device packaging. 3.5. If a lot number, serial number, software identification or expiry date appears on the label, it shall be part of the UDI-PI. If there is also a manufacturing date on the label, it does not need to be included in the UDI-PI. If there is only a manufacturing date on the label, this shall be used as the UDI-PI. 3.6. Each component that is considered to be a device and is commercially available on its own shall be assigned a separate UDI unless the components are part of a configurable device that is marked with its own UDI. 3.7. Systems and procedure packs as referred to in Article 22 shall be assigned and bear their own UDI. 3.8. The manufacturer shall assign the UDI to a device following the relevant coding standard. 3.9. A new UDI-DI shall be required whenever there is a change that could lead to misidentification of the device and/or ambiguity in its traceability; in particular, any change of one of the following UDI database data elements shall require a new UDI-DI: (a) name or trade name, (b) device version or model, (c) labelled as single use, (d) packaged sterile, (e) need for sterilization before use, (f) quantity of devices provided in a package, (g) critical warnings or contra-indications: e.g. containing latex or DEHP. 3.10. Manufacturers that repackage and/or relabel devices, with their own label shall retain a record of the original device manufacturer's UDI. 4. UDI carrier 4.1. The UDI carrier (AIDC and HRI representation of the UDI) shall be placed on the label or on the device itself and on all higher levels of device packaging. Higher levels do not include shipping containers. 4.2. In the event of there being significant space constraints on the unit of use packaging, the UDI carrier may be placed on the next higher packaging level. 4.3. For single-use devices of classes I and IIa packaged and labelled individually, the UDI carrier shall not be required to appear on the packaging but it shall appear on a higher level of packaging, e.g. a carton containing several individually packaged devices. However, when the healthcare provider is not expected to have access, in cases such as in home healthcare settings, to the higher level of device packaging, the UDI shall be placed on the packaging of the individual device.",MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1,EU,EU MDR; EU IVDR,,Traceability UDI-DI,UDI device identifier,A unique numeric or alphanumeric code specific to a model of device and that is also used as the ‘access key’ to information stored in a UDI database.,MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1,EU,EU MDR; EU IVDR,,Traceability UDI-PI,UDI production identifier,"A numeric or alphanumeric code that identifies the unit of device production. The different types of UDI-PIs include serial number, lot number, software identification and manufacturing or expiry date or both types of date.",MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1,EU,EU MDR; EU IVDR,,Traceability Unit of Use DI,Unit of Use device identifier,"Serves to associate the use of a device with a patient in instances in which a UDI is not labelled on the individual device at the level of its unit of use, for example in the event of several units of the same device being packaged together.",MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1,EU,EU MDR; EU IVDR,,Traceability Up-classification,Up-classification,"A device moving to a higher risk class under the regulation than it held under the directives, usually because of a changed or newly added classification rule. The consequence is a different conformity assessment route and, often, notified body involvement where there was none before.",MDR Annex VIII,EU,EU MDR,,Classification user,User,Any healthcare professional or lay person who uses a device.,MDR Article 2(37); IVDR Article 2(30),EU,EU MDR; EU IVDR,,Economic operators Vigilance,Vigilance reporting,"The reporting of serious incidents and field safety corrective actions to competent authorities within prescribed deadlines, followed by investigation and, where needed, corrective action. Distinct from post-market surveillance, which is the wider ongoing data-gathering activity.",MDR Article 87; IVDR Article 82,EU,EU MDR; EU IVDR,,Vigilance WET,Well-established technology,"A mature technology for which extensive, long-standing experience exists. The MDR does not define the term, but uses the concept in two places: exempting certain class IIb implantable devices from device-by-device technical documentation assessment, and exempting certain implantable and class III devices from the requirement to conduct clinical investigations.",MDR Article 52(4) and Article 61(6)(b),EU,EU MDR,,Conformity assessment withdrawal,Withdrawal,Any measure aimed at preventing a device in the supply chain from being further made available on the market.,MDR Article 2(63); IVDR Article 2(66),EU,EU MDR; EU IVDR,,Vigilance