Kontaktieren Sie uns: +49 251 978240-0
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 clinical investigation /performance study, whether or not related to the investigational device /device for performance studyand whether anticipated or unanticipated.(Def. acc. to MDR /IVDR/ISO 14155:2020)
Conscious, deliberate act or deliberate omission of an act that is counter to or violates normal use and is also beyond any further reasonable means of user interface-related risk control by the manufacturer. For example: Reckless use or sabotage or deliberate disregard of information for safety.(Def. acc. to IEC 62366-1:2015)
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).(Def. acc. to IVDR)
„Briefly describe how benchmarks for safety and performance have been identified by the manufacturer in terms of the state of the art. Benchmarks will normally be based on aggregate data from several devices considered to have acceptable performance (e.g. systematic reviews or registry analysis); if individual devices are selected as benchmarks for safety and performance, a suitable rationale should be provided.“
(Def. acc. to MDCG 2020-13)
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).
(Def. acc. to IVDR)
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).
(Def. acc. to MDR)
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).
(Def. acc. to MDR)
Materials accompanying a medical device and containing information for the user or those accountable for the installation, use, maintenance, decommissioning and disposal of the medical device, particularly regarding safe use.
Accompanying documents can consist of the IFU, technical description, installation manual, quick reference guide, etc.
Accompanying documents is not necessarily a written or printed document but could involve auditory, visual, or tactile materials and multiple media types.
(Def. acc. to ISO 14971:2019 / IEC 62366-1:2015)
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.
(Def. acc. to MDR)
Adverse event related to the use of an investigational medical device.
This definition includes adverse events resulting from insufficient or inadequate IFU, deployment, implantation, installation, or operation, or any malfunction of the investigational medical device.
(Def. acc. to ISO 14155:2020)
For the purpose of the definition of nanomaterial, means 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.
(Def. acc. to MDR)
For the purpose of the definition of nanomaterial, means a particle comprising of strongly bound or fused particles.
(Def. acc. to MDR)
The ability of a device to correctly detect or measure a particular analyte.
(Def. acc. to IVDR)
An effect which by its nature, incidence, severity or outcome has been identified in the risk assessment.
(Def. acc. to ISO 14155:2020)
Systematic examination of activities and documents related to a clinical investigation performed by (an) independent person(s), to determine whether these activities were conducted, and the data recorded, analyzed and accurately reported, according to the CIP, standard operating procedures, this document and applicable regulatory requirements.
(Def. acc. to ISO 14155:2020)
Any form of electronically accessible information supplied by the manufacturer related to a medical device.
(Def. acc. to ISO 1041:2013-12)
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 the MDR / IVDR.
(Def. acc. to MDR / IVDR)
Defined amount of material or a number of devices, including finished product and accessories, that is processed in one process or a series of related processes.(Def. acc. to ISO 1041:2013-12)
Unique identifier associated with a single batch or lot.
(Def. acc. to ISO 1041:2013-12)
Positive impact or desirable outcome of the use of a medical device on the health of an individual, or a positive impact on patient management or public health.
Benefits can include positive impact on clinical outcome, the patient’s quality of life, outcomes related to diagnosis, positive impact from diagnostic devices on clinical outcomes, or positive impact on public health.(Def. acc. to ISO 14971:2019)
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.
(Def. acc. to MDR / IVDR)
A measurement reference material used in the calibration of a device.
(Def. acc. to IVDR)
Set of printed, optical or electronic documents for each subject on which information to be reported to the sponsor is recorded, as required by the CIP.
(Def. acc. to ISO 14155:2020)
Process of obtaining chemical information, accomplished either with information gathering or by information generation, for example, by literature review or chemical testing.
(Def. acc. to ISO 10993-18:2020)
Qualitative and quantitative, if applicable, knowledge related to the configuration, composition, and production of the medical device and/or its materials of construction, thereby establishing the identities and amounts of constituents present in the materials and device.
Chemical information can be used to establish the hypothetical worst-case release of chemicals from a medical device, predicated on the circumstances that all chemicals present in the device are released from the device under its clinical conditions of use.
(Def. acc. to ISO 10993-18:2020)
A marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in the MDR / IVDR and other applicable Union harmonization legislation providing for its affixing.
(Def. acc. to MDR / IVDR)
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.
(Def. acc. to MDR)
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.
(Def. acc. to IVDR)
Information concerning safety and 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.
(Def. acc. to MDR)
A systematic and planned process to continuously generate, collect, analyze, 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.
(Def. acc. to MDR)
Clinical data and clinical evaluation / performance evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is sage and achieves the intended clinical benefit(s), when used as intended by the manufacturer.
(Def. acc. to MDR / IVDR)
A document that describes the rationale, objectives, design and pre-specified analysis, methodology, monitoring, statistical considerations, organization, and conduct and record-keeping of a clinical investigation.
(Def. acc. to MDR / ISO 14155:2020)
Document describing the design, execution, statistical analysis and results of a clinical investigation.
(Def. acc. to ISO 14155:2020)
Medical device, component, or material of construction which has been used extensively for specified and established clinical uses for which biocompatibility has been established.
(Def. acc. to ISO 10993-18:2020)
The ability of a device, resulting from any direct or indirect medical effects which stem from its technical or functional characteristics, including diagnosis 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.
(Def. acc. to MDR)
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.
(Def. acc. to IVDR)
Behavior of a medical device and response of the subject(s) to that medical device in relation to its intended use, when correctly applied to appropriate subject(s).
Clinical performance can be defined under national regulations.
(Def. acc. to ISO 14155:2020)
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.
(Def. acc. to MDR / IVDR)
A device which is essential for the safe and effective use of a corresponding medicinal product to:
Identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or
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.
(Def. acc. to IVDR)
Medical device, therapy (e.g., active treatment, normal clinical practice), placebo or no treatment, used in the control group in a clinical investigation.
(Def. acc. to ISO 14155:2020)
The ability of a device, including software, when used together with one or more other devices in accordance with its intended purpose, to:
Perform without losing or compromising the ability to perform as intended, and/or
Integrate and/or operate without the need for modification or adaption of any part of the combined device, and/or
Be used together without conflict/interference or adverse reaction.
(Def. acc. to MDR / IVDR)
Item which forms one part of a medical device, but is not itself a medical device.
(Def. acc. to ISO 10993-18:2020)
The process demonstrating whether the requirements of the MDR / IVDR relating to a device have been fulfilled.
(Def. acc. to MDR / IVDR)
A body that performs third-party conformity assessment activities including calibration, testing, certification, and inspection.
(Def. acc. to MDR / IVDR)
Chemical that is present in a finished medical device or its materials of construction.
Constituents may be intentionally present (e.g., an additive such as an antioxidant) or unintentionally present (e.g., an impurity or degradant).
(Def. acc. to ISO 10993-18:2020)
Person or organization contracted by the sponsor to perform one or more of the sponsor’s clinical investigation-related duties and functions.
(Def. acc. to ISO 14155:2020)
Group of subjects that receives the comparator.
(Def. acc. to ISO 14155:2020)
A substance, material or article intended by its manufacturer to be used to verify the performance characteristics of a device.
(Def. acc. to IVDR)
Investigator who is appointed by the sponsor to assist in coordinating the work in a multicenter clinical investigation.
(Def. acc. to ISO 14155:2020)
Action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation.
(Def. acc. to MDR / IVDR)
Normal use without use error.
(Def. acc. to IEC 62366-1:2015)
Any device specifically made in accordance with a written prescription of any person authorized 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 authorized person shall not be considered to be custom-made devices.
(Def. acc. to MDR)
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.
(Def. acc. to MDR)
Instance of failure to follow, intentionally or unintentionally, the requirements of the CIP.
(Def. acc. to ISO 14155:2020)
Any inadequacy in the identity, quality, durability, reliability, usability, safety or performance of an investigational device / a device for performance study, including malfunction, use errors, or inadequacy in information supplied by the manufacturer including labelling.
(Def. acc. to MDR / IVDR / ISO 14155:2020)
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.
(Def. acc. to IVDR)
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.
(Def. acc. to IVDR)
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 healthcare professional.
(Def. acc. to IVDR)
The ability of a device to identify the presence of a target marker associated with a particular disease or condition.
(Def. acc. to IVDR)
The ability of a device to recognize the absence of a target marker associated with a particular disease or condition.
(Def. acc. to IVDR)
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.
(Def. acc. to MDR / IVDR)
A manufacturer, an authorized representative, an importer, a distributor (or the person referred to in Art. 22 (1) and (3) MDR).
(Def. acc. to MDR / IVDR)
Achievement of a clinically significant intended result in a defined portion of the target population when the investigational medical device is used within its intended uses and according to its instructions for use, the investigator’s brochure and the CIP, as determined by documented scientific evidence.
(Def. acc. to ISO 14155:2020)
Accuracy and completeness with which users achieve specific goals.
(Def. acc. to IEC 62366-1:2015)
Resources expended in relation to effectiveness.
(Def. acc. to IEC 62366-1:2015)
Indicator(s) used for providing the evidence for clinical performance, effectiveness or safety in a clinical investigation.
(Def. acc. to ISO 14155:2020)
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 the MDR / IVDR , taking into account the views of lay persons, in particular patients or patients’ organizations.
(Def. acc. to MDR / IVDR)
Independent body whose responsibility it is to review clinical investigations in order to protect the rights, safety, and well-being of human subjects participating in a clinical investigation.
(Def. acc. to ISO 14155:2020)
Time period specified by the manufacturer during which the medical device us expected to remain safe for use (i.e. maintain basic safety and essential performance).
Maintenance can be necessary during the expected service life.
(Def. acc. to IEC 62366-1:2015)
Substance that is released form a medical device or material of construction when the medical device or material is extracted using laboratory extraction conditions and vehicles.
(Def. acc. to ISO 10993-18:2020)
Medium (solution or solvent) which is used to extract (or leach) a test article for the purpose of establishing the test article’s extractables or leachables profile.
It is preferred that extraction vehicles be analytically expedient.
For some medical devices (e.g., infusion systems) that are labelled for use with a drug, the most appropriate extraction medium may be the drug product vehicle.
(Def. acc. to ISO 10993-18:2020)
Any device with a false presentation of its identity and/or 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.
(Def. acc. to MDR / IVDR)
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.
(Def. acc. to MDR / IVDR)
A communication sent by a manufacturer to users or customers in relation to a field safety corrective action.
(Def. acc. to MDR / IVDR)
User interface evaluation conducted with the intent to explore user interface design strengths, weaknesses, and unanticipated use errors.
Formative evaluation if generally performed iteratively throughout the design and development process, but prior to summative evaluation, to guide user interface design as necessary.
(Def. acc. to IEC 62366-1:2015)
For the purpose of the definition of manufacturer, means 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 the MDR / IVDR, combined with the assignment of a new lifetime to the refurbished device.
(Def. acc. to MDR / IVDR)
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.
(Def. acc. to MDR / IVDR)
Injury or damage to the health of people, or damage to property or the environment.
(Def. acc. to ISO 14971:2019)
A European standard as defined in point (1)(c) of Art. 2 of Regulation (EU) No 1025/2012.
(Def. acc. to MDR / IVDR)
Potential source of harm.
(Def. acc. to ISO 14971:2019)
Circumstances in which people, property or the environment is/are exposed to one or more hazards.
(Def. acc. to ISO 14971:2019)
Use scenario that could lead to a hazardous situation or harm.
A hazard-related use scenario can often be linked to a potential use error and is not related to a failure of the medical device, unless the medical device failure was caused by a use error.
(Def. acc. to IEC 62366-1:2015)
An organization the primary purpose of which is the care or treatment of patients or the promotion of public health.
(Def. acc. to MDR / IVDR)
Testable statement, derived from the objective of the clinical investigation to draw a conclusion about this objective, based on a pre-specified statistical test.
The primary hypothesis is formulated based on the pre-defined primary endpoint and is usually used to calculate the sample size.
(Def. acc. to ISO 14155:2020)
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.
(Def. acc. to MDR)
Any natural or legal person established within the Union that places a device from a third country on the Union market.
(Def. acc. to MDR / 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 undesirable side-effect / 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.
(Def. acc. to MDR / IVDR)
Not involved in the development of the investigational device or the conduct of a clinical investigation, except for their specifically assigned responsibilities, in order to avoid bias or a conflict of interest.
(Def. acc. to ISO 14155:2020)
Refers to the clinical condition that is to be diagnosed, prevented, monitored, treated, alleviated, compensated for, replaced, modified or controlled by the medical device. It should be distinguished from ‘intended purpose/intended use’, which describes the effect of a device. All devices have an intended purpose/intended use, but not all devices have an indication (e.g. medical devices with an intended purpose of disinfection or sterilization of devices).
(Def. acc. to MDCG 2020-6)
All material, however provided, relating to the identification, technical description and use of a medical device that is intended to ensure the safe, effective an compliant use of the device.
Shipping documents and promotional material are excluded from this definition when identification, technical description and use of a medical device are not intended to ensure the safe, effective and compliant use of the device.
(Def. acc. to ISO 1041:2013-12)
A subject’s free and voluntary expression of his or her willingness to participate in a particular clinical investigation / performance study, after having been informed of all aspects of the clinical investigation / performance study that are relevant to the subject’s decision to participate or, in the case of minors and of incapacitated subjects, an authorization or agreement from their legally designated representative to include them in the clinical investigation / performance study.
(Def. acc. to MDR / IVDR)
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.
(Def. acc. to MDR / 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 and as specified by the manufacturer in the clinical evaluation/ performance evaluation.
(Def. acc. to MDR / IVDR)
Use for which a product, process or service is intended according to the specifications, instructions and information provided by the manufacturer.
The intended medical condition, patient population, part of the body or type of tissue interacted with, user profile, use environment, and operating principle are typical elements of the intended use.
(Def. acc. to ISO 14971:2019)
The MDR defines ‘intended purpose’, but not ‘intended use’. ‘intended use’ should be considered to have the same meaning as ‘intended purpose’.
(Def. acc. to MDCG 2020-6)
The ability of two or more devices, including software from the same manufacturer or from different manufacturers, to:
Exchange information and use the information that has been exchanged for the correct execution of a specific function without changing the content of the data, and/or
Communicate with each other, and/or
Work together as intended.
(Def. acc. to MDR / IVDR)
A clinical performance study where the test results may influence patient management decisions and/or may be used to guide treatment.
(Def. acc. to IVDR)
Any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body.
(Def. acc. to MDR)
Institution or site where the clinical investigation is carried out.
(Def. acc. to ISO 14155:2020)
Medical device being assessed for clinical performance, effectiveness, or safety in a clinical investigation.
This includes medical devices already on the market that are being evaluated for new intended uses, new populations, new materials or design changes.
This includes medical devices already on the market that are being evaluated within their intended use in a post-market clinical investigation (interventional or non-interventional).
(Def. acc. to ISO 14155:2020)
An individual responsible for the conduct of a clinical investigation / performance study at a clinical investigation / performance study site.
(Def. acc. to MDR / IVDR)
Individual member of the investigation site team designated and supervised by the principal investigator at an investigation site to perform clinical investigation-related procedures or to make important clinical investigation-related and medical treatment decisions.
An individual member of the investigation site team can also be called “sub-investigator” or “co-investigator”.
(Def. acc. to ISO 14155:2020)
Compilation of the current clinical and non-clinical information on the investigational medical device(s), relevant to the clinical investigation.
(Def. acc. to ISO 14155:2020)
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:
Concerning a physiological or pathological process or state;
Concerning congenital physical or mental impairments;
Concerning the predisposition to a medical condition or a disease;
To determine the safety and compatibility with potential recipients;
To predict treatment response or reactions;
To define or monitoring therapeutic measures.
Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices.
(Def. acc. to IVDR)
Device, whether used alone or in combination, intended by the manufacturer for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnosis, monitoring or compatibility purposes and including reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles.
(Def. acc. to ISO 14971:2019)
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.
(Def. acc. to IVDR)
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.
(Def. acc. to MDR / IVDR)
An individual who does not have formal education in a relevant field of healthcare or medical discipline.
(Def. acc. to MDR / IVDR)
Substance that is released from a medical device or material during its clinical use.
(Def. acc. to ISO 10993-18:2020)
This is considered to include all devices previously CE marked under the European Medical Devices Directive 93/42/EEC (MDD) or Active Implantable Medical Devices Directive 90/385/EEC (AIMDD).
(Def. acc. to MDCG 2020-6)
Individual, judicial, or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject’s participation in a clinical investigation.
(Def. acc. to ISO 14155:2020)
This terminology is used in the MDR with respect to requirements for demonstration of conformity with the relevant GSPR and overall benefit-risk. It is understood to encompass the amount and quality of evidence (i.e. its characterization by quality, quantity, completeness and statistical validity, etc.) required to demonstrate safety, performance and the benefit-risk conclusion of a medical device. It should not be confused with the term ‘levels of evidence’ (as used in evidence-based medicine) which is used to rank study designs, and is only a part of the concept ‘level of clinical evidence’.
(Def. acc. to MDCG 2020-6)
Series of all phases in the life of a medical device, from the initial conception to final decommissioning and disposal.
(Def. acc. to ISO 14971:2019)
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.
(Def. acc. to IVDR)
The condition by which substances remain in a specific site without being distributed into the body via the blood and/or
lymphatic system (MDCG 2021-24)
Any supply of a device, other than an investigational device / 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.
(Def. acc. to MDR / IVDR)
Failure of an investigational medical device to perform in accordance with its intended purpose when used in accordance with the instructions for use or CIP, or IB.
(Def. acc. to ISO 14155:2020)
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.
(Def. acc. to MDR / IVDR)
The natural or legal person has ultimate legal responsibility for ensuring compliance with all applicable regulatory requirements for the medical device in the countries or jurisdiction where it is intended to be made available or sold, unless this responsibility is specifically imposed on another person by the Regulatory Authority within that jurisdiction.
The manufacturer’s responsibilities are described in GHFT guidance documents. These responsibilities include meeting both pre-market requirements and post-market requirements, such as adverse event reporting and notification of corrective actions.
“Design and/or manufacture” may include specification development, production, fabrication, assembly, processing, packaging, repackaging, labelling, relabelling, sterilization, installation, or remanufacturing of a medical device; or putting a collection of devices, and possibly other products, together for a medical purpose.
Any person who assembles or adapts a medical device that has already been supplied by another person for an individual patient, in accordance with the IFU, is not the manufacturer, provided the assembly or adaptation does not change the intended use of the medical device.
A person who changes the intended use of, or modifies, a medical device without acting on behalf of the original manufacturer and who makes it available for use under his own name, should be considered the manufacturer of the modified medical device.
An authorized representative, distributor or importer who only adds its own address and contact details to the medical device or the packaging, without covering or changing the existing labelling, is not considered a manufacturer.
Listing of the constituents that are contained in a material (qualitative) and the amount of each substance in the material (quantitative).
A material’s composition establishes the hypothetical situation in which the total amount of all substances present in a medical device are released during clinical use. These amounts can be derived directly from known composition; experimentally, they can be derived from digestion, dissolution, and, in many cases, exhaustive extraction studies.
(Def. acc. to ISO 10993-18:2020)
Any instrument, apparatus, appliance, software, implant, reagent for in vitro use, material or other similar or related 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, any injury or disability,
Investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
Supporting or sustaining life,
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 sterilization of devices as referred to in Art. 1 (4) (MDR) and of those referred to in the first paragraph of this definition.
(Def. acc. to MDR and ISO 14971:2019)
Act of overseeing the progress of a clinical investigation to ensure that it is conducted, recorded, and reported in accordance with the CIP, written procedures, this document, and the applicable regulatory requirements.
Centralized monitoring is a remote evaluation of accumulated data and compliance to provide additional monitoring capabilities that can complement or reduce the extent and frequency of on-site monitoring.
(Def. acc. to ISO 14155:2020)
Clinical investigation that is conducted according to a single CIP and takes place at two or more investigation sites.
(Def. acc. to ISO 14155:2020)
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.
(Def. acc. to MDR)
The ability of a device to separate true negative results from false negative results for a given attribute in a given population.
(Def. acc. to IVDR)
Having no potential for metabolism or multiplication.
(Def. acc. to MDR)
Operation, including routine inspection and adjustments by any user, and stand-by, according to the instructions for use or in accordance with generally accepted practice for those medical devices provided without instructions for use.
Normal use should not be confused with intended use. While both include the concept of use as intended by the manufacturer, intended use focuses on the medical purpose while normal use incorporates not only the medical purpose, but maintenance, transport, etc. as well.
Use error can occur in normal use.
(Def. acc. to IEC 62366-1:2015)
Main purpose for conducting the clinical investigation.
(Def. acc. to ISO 14155:2020)
A conformity assessment body designated in accordance with the MDR / IVDR.
(Def. acc. to MDR / IVDR)
Data supporting the existence or verity of something.
Objective evidence can be obtained through observation, measurement, test or by other means.
(Def. acc. to ISO 14971:2019)
For the purpose of the definition of nanomaterial, means a minute piece of matter with defined physical boundaries.
(Def. acc. to MDR)
Living being (person) undergoing a medical, surgical or dental procedure. A patient can be a user.
(Def. acc. to IEC 62366-1:2015)
The ability of a device to achieve its intended purpose as stated by the manufacturer.
(Def. acc. to MDR)
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.
(Def. acc. to IVDR)
An assessment and analysis of data to establish or verify the scientific validity, the analytical and, where applicable, the clinical performance of a device.
(Def. acc. to IVDR)
A study undertaken to establish or confirm the analytical or clinical performance of a device.
(Def. acc. to IVDR)
A document that describes the rationale, objective, design methodology, monitoring, statistical considerations, organization and conduct of a performance study.
(Def. acc. to IVDR)
The first making available of a device, other than an investigational device / a device for performance study, on the Union market.
(Def. acc. to MDR / IVDR)
The ability of a device to separate true positive results from false positive results of a given attribute in a given population.
(Def. acc. to IVDR)
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.
(Def. acc. to MDR / IVDR)
Part of the life cycle of the medical device after the design has been completed and the medical device has been manufactured.
Example: Transportation, storage, installation, product use, maintenance, repair, product changes, decommission, and disposal.
(Def. acc. to ISO 14971:2019)
The probability that a person with a positive device test results has a given condition under investigation, or that a person with a negative device test result does not have a given condition.
(Def. acc. to IVDR)
Function that involves user interaction that is related to the safety of the medical device. Often a primary operating function is interacted with by a series of tasks that can be broken down into a series of user interactions.
(Def. acc. to IEC 62366-1:2015)
Qualified person responsible for conducting the clinical investigation at an investigation site.
If a clinical investigation is conducted by a team of individuals at an investigation site, the principle investigator is responsible for leading the team.
Whether this is the responsibility of an individual or an institution can depend on national regulations.
(Def. acc. to ISO 14155:2020)
Specified way to carry out an activity or a process.
Procedures can be documented or not.
(Def. acc. to ISO 14971:2019)
A combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose.
(Def. acc. to MDR)
Set of interrelated or interacting activities that use inputs to deliver an intended result.
Whether the “intended result” of a process is called output, product or service depends on the context of the reference.
Inputs to a process are generally the outputs of other processes and outputs of a process are generally the inputs to other processes.
Two or more interrelated and interacting processes in series can also be referred to as a process.
(Def. acc. to ISO 14971:2019)
The stage at which a device, other than an investigational device / 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.
(Def. acc. to MDR / IVDR)
Process of establishing that an analytical method is suitable for its intended use.
(Def. acc. to ISO 10993-18:2020)
Planned and systematic actions that are established to ensure that the clinical investigation is performed, and the data are generated, documented (recorded), and reported in compliance with the standard and the applicable regulatory requirement(s).
(Def. acc. to ISO 14155:2020)
Operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the clinical investigation-related activities have been fulfilled.
(Def. acc. to ISO 14155:2020)
Process of assigning a concentration to an analyte present in a sample.
(Def. acc. to ISO 10993-18:2020)
Process of assigning subjects to the investigational medical device or control groups using an established recognized statistical method using an element of chance to determine the unforeseeable assignment in order to reduce bias.
(Def. acc. to ISO 14155:2020)
Use of a product or system in a way not intended by the manufacturer, but which can result from readily predictable human behavior.
Readily predictable human behavior includes the behavior of all types of users, e.g., lay and professional users.
Reasonably foreseeable misuse can be intentional or unintentional.
(Def. acc. to ISO 14971:2019)
Any measure aimed at achieving the return of a device that has already been made available to the end user.
(Def. acc. to MDR / IVDR)
Document stating results achieved or providing evidence of activities performed.
Records can be used, for example, to formalize traceability and to provide evidence of verification, preventive actions, and corrective actions.
(Def. acc. to ISO 14971:2019)
Active efforts to identify subjects who can be suitable for enrolment into the clinical investigation.
(Def. acc. to ISO 14155:2020)
A process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilization, and related procedures, as well as testing and restoring the technical and functional safety of the used device.
(Def. acc. to MDR)
Risk remaining after risk control measures have been implemented.
(Def. acc. to ISO 14971:2019)
Entity accountable for the use and maintenance of a medical device or combination of medical devices. The accountable entity can be, for example, a hospital, an individual clinician or a lay person. In home use applications, the patient, user and responsible organization can be one and the same person.
Education and training are included in “use”.
(Def. acc. to IEC 62366-1:2015)
The combination of the probability of occurrence of harm and the severity of that harm.
(Def. acc. to MDR / IVDR and ISO 14971:2019)
Systematic use of available information to identify hazards and to estimate the risk.
(Def. acc. to ISO 14971:2019)
Overall process comprising risk analysis and risk evaluation.
(Def. acc. to ISO 14971:2019)
Process in which decisions are made and measures implemented by which risks are reduced to, or maintained within, specified levels.
(Def. acc. to ISO 14971:2019)
Process used to assign values to the probability of occurrence of harm and the severity of that harm.
(Def. acc. to ISO 14971:2019)
Process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk.
(Def. acc. to ISO 14971:2019)
Systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk.
(Def. acc. to ISO 14971:2019)
Set of records and other documents that are produced by risk management.
(Def. acc. to ISO 14971:2019)
Freedom of unacceptable risk.
(Def. acc. to ISO 14971:2019)
Threshold which a leachable (or an extractable as a probable leachable) has a dose so low that it presents a negligible safety concern from carcinogenic and non-carcinogenic toxic effects.
(Def. acc. to ISO 10993-18:2020)
This terminology is used in the MDR in reference to clinical data planning, evaluation and conclusions. Clinical evaluations must follow a “defined and methodologically sound procedure”, for which expectations of scientific validity are implicit. Embedded in the term ‘scientific validity’ are concepts including adequacy of study design and controls for bias, appropriateness and relevance of research questions, adequacy of sample sizes and statistical analyses, completeness of data, adequacy of follow up period, and appropriateness of conclusions on the basis of objective evidence.
Section 9.3.1 of MEDDEV 2.7/1 rev. 4 provides guidance for the evaluation of methodological quality and scientific validity under the MDD/AIMDD which are equally valid under the MDR which can be considered to apply when referencing ‘scientific validity’.
(Def. acc. to MDCG 2020-6)
The association of an analyte with a clinical condition of a physiological state.
(Def. acc. to IVDR)
Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event.
(Def. acc. to ISO 14155:2020)
Any adverse event that led to any of the following:
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,
Death,
Serious deterioration in the health of the subject / individual being tested or the recipient of tested donations or materials, that resulted in any of the following:
Life-threatening illness or injury,
Permanent impairment of a body structure or a body function,
Hospitalization of prolongation of patient hospitalization,
Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,
Chronic disease,
Foetal distress, foetal death or a congenital physical or mental impairment or birth defect.
(Def. acc. to MDR / IVDR)
Signal from any adverse event or device deficiency that indicates an imminent risk of death or a serious deterioration in the health in subjects, users or other persons, and that requires prompt remedial action for other subjects, users or other persons.
This would include events that are of significant and unexpected nature such that they become alarming as a potential serious health hazard or possibility of multiple deaths occurring at short intervals.
(Def. acc. to ISO 14155:2020)
Any incident that directly or indirectly led, might have led or might lead to any of the following:
The death of a patient, user or other person,
The temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health.
A serious public health threat.
(Def. acc. to MDR / IVDR)
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.
(Def. acc. to MDR / IVDR)
Measure of the possible consequences of a hazard.
(Def. acc. to ISO 14971:2019)
‘side effect’ is an effect other than the intended effect of a device while using the device as intended. Side effects can be harmful or beneficial. Example: allergies, pain
(PL internal definition)
An ‘undesirable side-effect’ under the MDR should be understood as any unintended and unwanted medical manifestation in the human body, as a consequence of the normal use of a medical device. Undesirable side-effects are not the result of a malfunction, deterioration in the characteristics or performance of the medical device, or an inadequacy in the information supplied by the manufacturer. It should be noted that the terms ‘undesirable side-effects’ and ‘side-effects’ are used synonymously in the MDR
(Def. acc. to MDCG 2023-3 Rev. 1)
Devices belonging to the same generic device group. The MDR defines this as 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.
(MDCG 2020-6)
All information in original records, certified copies of original records of clinical findings, observations, or other activities in a clinical investigation, necessary for the reconstruction and evaluation of the clinical investigation.
This includes source data initially recorded in an electronic format.
(Def. acc. to ISO 14155:2020)
Original or certified copy of printed, optical or electronic document containing source data. For example: hospital records, laboratory notes, radiographs, records kept at the investigation site, …
(Def. acc. to ISO 14155:2020)
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.
(Def. acc. to IVDR)
IMDRF/GRRP WG/N47 provides the following definition:
Developed stage of current technical capability and/or accepted clinical practice at a given time in regard to products, processes, services, and patient management, based on the relevant consolidated findings of science, technology and experience.
Note: The state-of-the-art embodies what is currently and generally accepted as good practice in technology and medicine. The state-of-the-art does not necessarily imply the most technologically advanced solution. The state-of-the-art described here is sometimes referred to as the “generally acknowledged state-of the-art.
(Def. acc. to MDCG 2020-6 and ISO 14971:2019)
The state of the art embodies what is currently and generally accepted as good practice in technology and medicine. The state of the art does not necessarily imply the most technologically advanced solution. The state of the art described here is sometimes referred to as the “generally acknowledged state of the art”.
(Def. acc. to ISO 14971:2019)
An individual who participates in a clinical investigation.
(Def. acc. to MDR)
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 for control purposes.
(Def. acc. to IVDR)
User interface evaluation conducted at the end of the user interface development with the intent to obtain objective evidence that the user interface can be used safely. Summative evaluation relates to validating the safe use of the user interface.
(Def. acc. to IEC 62366-1:2015)
Person or company who manufactures or provides the materials of construction or components to be used in the manufacture of a medical device.
(Def. acc. to ISO 10993-18:2020)
A combination of products, either packaged together or not, which are intended to be inter-connected or combined to achieve a specific medical purpose.
(Def. acc. to MDR)
One or more user interactions with a medical device to achieve a desired result.
A task description should include the allocation of activities and operational steps between the user and the medical device. Tasks should not be described solely in terms of the functions or features provided by the medical device.
(Def. acc. to IEC 62366-1:2015)
Level of exposure for constituents, below which there would be no appreciable risk to human health.
(Def. acc. to ISO 10993-18:2020)
Person or group of people who directs and controls a manufacturer at the highest level.
(Def. acc. to ISO 14971:2019)
Serious adverse device effect which by its nature, incidence, severity or outcome has not been identified in the current risk assessment.
Anticipated serious adverse device effect is an effect which by its nature, incidence, severity or outcome has been identified in the risk assessment.
(Def. acc. to ISO 14155:2020)
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.
(Def. acc. to MDR / IVDR)
User interface or part of a user interface of a medical device previously developed for which adequate records of the usability engineering process of the usability standard are not available.
(Def. acc. to IEC 62366-1:2015)
Characteristics of the user interface that facilitates use and thereby establishes effectiveness, efficiency and user satisfaction in the intended use environment.
All aspects of usability, including effectiveness, efficiency and user satisfaction, can either increase or decrease safety.
(Def. acc. to IEC 62366-1:2015)
Application of knowledge about human behavior, abilities, limitations, and other characteristics to the design of medical devices (including software), systems and tasks to achieve adequate usability.
(Def. acc. to IEC 62366-1:2015)
Set of records and other documents that are produced by the usability engineering process.
(Def. acc. to IEC 62366-1:2015)
Method for exploring or evaluating a user interface with intended users within a specified intended use environment.
(Def. acc. to IEC 62366-1:2015)
Actual conditions and setting in which users interact with the medical device.
The conditions of use or attributes of the use environment can include hygienic requirements, frequency of use, location, lighting, noise, temperature, mobility, and degree of internationalization. Social attributes such as team versus individual, chaotic versus calm, stress level and length of shift can also play a role.
(Def. acc. to IEC 62366-1:2015)
User action or lack of user action while using the medical device that leads to a different result than that intended by the manufacturer or expected by the user
Use error includes the inability of the user to complete a task.
Use errors can result from a mismatch between the characteristics of the user, user interface, task or use environment.
Users might be aware or unaware that a use error has occurred.
An unexpected physiological response of the patient is not by itself considered a use error.
A malfunction of a medical device that causes an unexpected result is not considered a use error.
(Def. acc. to ISO 14155:2020 and ISO 14971:2019 / IEC 62366-1:2015)
Any healthcare professional or lay person who uses a device.
(Def. acc. to MDR / IVDR)
Person interacting with (i.e. operating or handling) the medical device. There can be more than one user of a medical device. Common users include clinicians, patients, cleaners, maintenance and service personnel.
(Def. acc. to IEC 62366-1:2015)
Any person, legal or natural, for whom the information supplied is intended.
(Def. acc. to ISO 1041:2013-12)
Subset of users who are differentiated from other users by factors that are likely to influence their interactions with the medical device.
Attributes of user groups can include age, culture, expertise.
(Def. acc. to IEC 62366-1:2015)
Means by which the user and the medical device interact.
Accompanying documentation is considered part of the medical device and its user interface.
User interface includes all the elements of the medical device with which the user interacts including the physical aspects of the medical device as well as visual, auditory, tactile displays and is not limited to a software interface.
A system of medical devices can be treated as a single user interface.
(Def. acc. to IEC 62366-1:2015)
Process by which the manufacturer explores or assesses the user interactions with the user interface.
A user interface evaluation may consist of one or more of the following techniques, amongst others, usability tests, expert reviews, heuristic analyses, design audits or a cognitive walk through.
User inter face evaluation is frequently performed iteratively throughout the design and development process (this is formative evaluation).
User interface evaluation is a part of the activities involved in verifying and validating the overall medical device design (this is summative evaluation).
(Def. acc. to IEC 62366-1:2015)
Collection of specifications that comprehensively and prospectively describe the user interface of a medical device.
(Def. acc. to IEC 62366-1:2015)
Summary of the mental, physical and demographic traits of a user group, as well as characteristics, such as knowledge, skills and abilities, which can have a bearing on design decisions.
(Def. acc. to IEC 62366-1:2015)
Specific sequence of tasks performed by specific users in a specific use environment and any resulting response of the medical device.
(Def. acc. to IEC 62366-1:2015)
Summary of the important characteristics related to the context of use of the medical device.
The intended medical indication, patient population, part of the body or type of tissue interacted with, user profile, use environment, and operating principle are typical elements of the use specification.
The use specification is an input to determining the intended use of ISO 14971:2019.
(Def. acc. to IEC 62366-1:2015)
Confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.
(Def. acc. to ISO 14155:2020)
Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.
(Def. acc. to ISO 14155:2020)
The objective evidence needed for a verification can be the result of an inspection or of other forms of determination such as performing alternative calculations or reviewing documents.
The activities carried out for verification are sometimes called a qualification process.
The word “verified” is used to designate the corresponding status.
(Def. acc. to ISO 14971:2019)
Individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response.
(Def. acc. to ISO 14155:2020)
This terminology is used in Article 52(5) and Article 61(8) of the MDR, but is not defined in these articles. The term is not restricted to the devices listed in Article 61(6b); Article 61(8) explicitly states that this includes devices similar to the exempted devices listed in Article 61(6b), which might be added to that list in future. The common features of the devices which are well-established technologies are that they all have:
relatively simple, common and stable designs with little evolution;
their generic device group has well-known safety and has not been associated with safety issues in the past;
well-known clinical performance characteristics and their generic device group are standard of care devices where there is little evolution in indications and the state of the art;
a long history on the market.
Therefore, any devices that meet all these criteria may be considered “well-established technologies”.
(Def. acc. to MDCG 2020-6)
Any measure at preventing a device in the supply chain from being further made available on the market.
(Def. acc. to MDR / IVDR)
Sie müssen den Inhalt von reCAPTCHA laden, um das Formular abzuschicken. Bitte beachten Sie, dass dabei Daten mit Drittanbietern ausgetauscht werden.
Mehr Informationen