MedTech Glossary
Go to glossary to look up MedTech regulatory terminology and definitions
for EU MDR, IVDR and FDA.
#
2017/746
Regulation (EU) 2017/746 (also known as the IVDR) details the essential requirements manufacturers and importers must meet to apply the CE marking and legally market or sell their in vitro diagnostic devices in the EU. The IVDR entered into force on May 25, 2017, and will replace the IVDD on May 26, 2022.
483
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that, in their judgment, may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related acts. Observations are made when, in the investigator’s judgment, conditions or practices observed would indicate that any food, drug, device, or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.
510(K)
A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is as safe and effective—that is, substantially equivalent—to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval.
513(G)
Section 513(g) of the Federal Food, Drug, and Cosmetic Act provides a means for device manufacturers to obtain information about the Food and Drug Administration’s views regarding the classification of a device.
90/385/EEC
Directive (EU) 90/385/EEC (also known as the Active Implantable Medical Devices Directive) specifies the essential requirements manufacturers and importers must meet to apply the CE marking and legally market or sell active implantable medical devices in the EU. The new EU Medical Device Regulation, (MDR (EU) 2017/745) replaced the EU directive on active implantable medical devices (90/385/EEC).
93/42/EEC
Directive (EU) 93/42/EEC (also known as the Medical Devices Directive – MDD) details the essential requirements manufacturers and importers must meet to apply the CE marking and legally market or sell their devices in the EU. The new EU Medical Device Regulation, (MDR (EU) 2017/745) replaced the Medical Device Directive (93/42/EEC) and the EU’s directive on active implantable medical devices (90/385/EEC).
98/79/EC
In vitro diagnostic medical devices (IVDs) are subject to European Directive 98/79/EC (IVDD). The EU IVDR will replace the IVDD on May 26, 2022.
A
ACCESSORY FOR A MEDICAL DEVICE
An accessory for a medical device is an article that is intended 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).
ACTIVE DEVICE
An active device is 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.
ACTIVE IMPLANTABLE MEDICAL DEVICE DIRECTIVE
The Active Implantable Medical Device Directive, 90/385/EEC of the European Union (EU), specifies the essential requirements manufacturers and importers must meet to apply the CE marking and legally market or sell active implantable medical devices in the EU. The new EU Medical Device Regulation, (MDR (EU) 2017/745) replaced the EU directive on active implantable medical devices (90/385/EEC).
ADVERSE EVENT
An adverse event is 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.
AGGLOMERATE
For the purposes of the definition of nanomaterial, aggregate means a particle comprising of strongly bound or fused particles.
AGGREGATE
An adverse event is 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.
ANALYTICAL EVALUATION THRESHOLD
Threshold below which the analyst need not identify or quantify leachables or extractables or report them for potential toxicological assessment.
ANALYTICAL PERFORMANCE
Analytical performance is the ability of a device to correctly detect or measure a particular analyte.
AUTHORISED REPRESENTATIVE
Authorized representative means any natural or legal person established within the European Union who has received and accepted a written mandate from a manufacturer—located outside the EU—to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations.
B
BENCHMARK DEVICE
A benchmark device is a device that has an identical ‘Intended purpose’ and ‘operating principles’ to the target device. The the differences are not significant in terms of clinical performance or safety outcomes. The three characteristics used to determine the benchmark for EU MDR 2017/745 are intended purpose, operating principles, and indication.
BENEFIT
A benefit is a 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.
BENEFIT-RISK DETERMINATION
Benefit-risk determination means 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.
BREXIT
Brexit is the term for the withdrawal of the United Kingdom from the European Union.
C
CHANGE NOTIFICATION/NOTICE
Application to the NB to apply significant changes to the device.
CE MARKING
CE marking is an indicator by which a manufacturer demonstrates that a device is in conformity with the applicable requirements set out in the MDR or IVDR and other applicable EU harmonization legislation providing for its affixing.
CLINICAL BENEFIT
Clinical benefit is 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.
CLINICAL DATA
Clinical data is information concerning safety or performance that is generated from the use of a device and is sourced from clinical investigation, published reports, or post-market surveillance of the device or equivalent devices.
CLINICAL EVALUATION
Clinical evaluation is 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.
CLINICAL EVALUATION PLAN
Under MDR, manufacturers must establish and update a clinical evaluation plan to show how the conformity route will be met. The CEP shall include: an identification of the general safety and performance requirements that require support from relevant clinical data; a specification of the intended purpose of the device; a clear specification of intended target groups with clear indications and contraindications; a detailed description of intended clinical benefits to patients with relevant and specified clinical outcome parameters; a specification of methods to be used for examination of qualitative and quantitative aspects of clinical safety with clear reference to the determination of residual risks and side effects; an indicative list and specification of parameters to be used to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio for the various indications, and for the intended purpose or purposes of the device; an indication of how benefit-risk issues relating to specific components such as use of pharmaceutical, nonviable animal or human tissues, are to be addressed; and a clinical development plan indicating progression from exploratory investigations, such as first-in-man studies, feasibility and pilot studies, to confirmatory investigations, such as pivotal clinical investigations, and a PMCF. The plan must also identify available clinical data relevant to the device and its intended purpose and any gaps in clinical evidence through a systematic scientific literature review, appraise all relevant clinical data by evaluating their suitability for establishing the safety and performance of the device, generate any new or additional clinical data necessary to address outstanding issues, and analyze all relevant clinical data in order to reach conclusions about the safety and clinical performance of the device including its clinical benefits.
CLINICAL EVALUATION REPORT
Under MDR, the results of the clinical evaluation and the clinical evidence on which it is based shall be documented in a clinical evaluation report which shall support the assessment of the conformity of the device. The clinical evidence together with nonclinical data generated from nonclinical testing methods and other relevant documentation shall allow the manufacturer to demonstrate conformity with the general safety and performance requirements and shall be part of the technical documentation for the device in question. Both favorable and unfavorable data considered in the clinical evaluation shall be included in the technical documentation.
CLINICAL EVIDENCE
Clinical evidence is clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s) when used as intended by the manufacturer.
CLINICAL INVESTIGATION
Clinical investigation is any systematic investigation involving one or more human subjects undertaken to assess the safety or performance of a device.
CLINICAL INVESTIGATION PLAN
A clinical investigation plan is a document that describes the rationale, objectives, design, methodology, monitoring, statistical considerations, organization, and conduct of a clinical investigation.
CLINICAL PERFORMANCE
Clinical performance is 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.
CLINICAL TRIAL
Clinical trials are voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, medical devices, other therapies, or new ways of using existing treatments.
CLINICAL TRIAL SPONSOR
A clinical trial sponsor is an entity that takes responsibility for and initiates a clinical trial. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator.
CLINICALLY ESTABLISHED
Medical device, component, or material of construction which has been used extensively for specified and established clinical uses for which biocompatibility has been established. ISO10993-1:2018
Leachable – a chemical substance that is released from a device during its clinical use.
Extractable – substance that is released from a medical device or material of construction when the medical device or material is extracted using laboratory extraction conditions and vehicles.
COMBINATION PRODUCT
A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product.
COMMON SPECIFICATIONS
Common specifications are 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. Common specifications are being issued by the European Commission under the MDR and IVDR.
COMPANION DIAGNOSTIC
A companion diagnostic is a device that is essential for the safe and effective use of a corresponding medicinal product to identify patients who are most likely to benefit and patients most likely to be at risk of serious adverse reactions.
COMPATIBILITY
Compatibility is the ability of a device, including software, when used together with one or more other devices in accordance with its intended purpose to perform as intended, integrate without the need for modification, and be used together without conflict or adverse reaction.
COMPETENT AUTHORITY
The European Medicines Agency works closely with the national competent authorities of the Member States of the European Union (EU) and the European Economic Area (EEA) responsible for human medicines. Competent authorities are primarily responsible for the authorization of medicines available in the EU that do not pass through the centralized procedure.
CONFORMITY
Conformity, or conformance itself, is the fulfilment of a requirement or specifications, whereas non-conformity is defined as the non-fulfilment of a requirement or specifications.
CONFORMITY ASSESSMENT
Conformity assessment means the process demonstrating whether the requirements of the MDR or IVDR relating to a device have been fulfilled.
CONFORMITY ASSESSMENT BODY
Conformity assessment body means a body that performs third-party conformity assessment activities including calibration, testing, certification, and inspection.
CONTRACT RESEARCH ORGANIZATION
Contract research organization means a person that assumes—as an independent contractor with the sponsor—one or more of the obligations of a sponsor (e.g., design of a protocol, selection or monitoring of investigations, evaluation of reports, and preparation of materials to be submitted to the Food and Drug Administration).
CORRECTIVE ACTION
Corrective action is any action taken to eliminate the cause of a potential or actual nonconformity or other undesirable situation.
CUSTOM-MADE DEVICE
A custom-made device is any device specifically made in accordance with a written prescription that describes specific design characteristics and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.
D
DATE OF APPLICATION
Date of Application (DoA) means the date the EU MDR is active. This date was 26 May 2021, when the MDR took effect. DoA has an impact on MDR compliant devices and legacy devices under Article 120, and it dictates obligations of PMS.
DERIVATIVE
A derivative is 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.
DESIGNATED MARKETING AUTHORIZATION HOLDER
Japan’s Pharmaceuticals and Medical Devices Act (PMD Act) defines the Marketing Authorization Holder (MAH) as the legal manufacturer in Japan. Foreign manufacturers assign a Japanese company that has a Marketing Authorization Holder license as the Designated Marketing Authorization Holder (DMAH). Then the foreign manufacturer makes and submits an application for approval/certification through the DMAH company. In this case, the foreign manufacturer owns the approval/certification, and the DMAH company works as an agent in Japan.
DEVICE DEFICIENCY
Device deficiency is 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.
DEVICE FOR NEAR-PATIENT TESTING
A device for near-patient testing is 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.
DEVICE FOR SELF-TESTING
A device for self-testing is any device intended by the manufacturer to be used by laypersons, including devices used for testing services offered to laypersons by means of information society services.
DIAGNOSTIC SENSITIVITY
Diagnostic sensitivity is the ability of a device to identify the presence of a target marker associated with a particular disease or condition.
DIAGNOSTIC SPECIFICITY
Diagnostic specificity is the ability of a device to recognize the absence of a target marker associated with a particular disease or condition.
DIRECT REFERENCE PROGRAM
Direct reference is a situation whereby the relevant FDA center grants the districts authority to issue a warning letter, enjoin firms, or seize products without direct center review and approval.
DISTRIBUTOR
Distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market up until the point of putting it into service.
E
EC REP
A European authorised representative (EC Rep) serves as a legal entity designated by non-European Union (EU) manufacturers to represent them in the EU and ensure their compliance with the European directives.
ECONOMIC OPERATOR
Economic operator means a manufacturer, an authorised representative, an importer, a distributor or the person referred to in Article 22(1) and 22(3) of EU MDR 2017/745.
ETHICS COMMITTEE
An Ethics Committee is an independent body established in a Member State in accordance with the law of that Member Sate and empowered to give opinions for the purposes of the EU MDR, taking into account the views of laypersons, in particular patients or patients’ organisations.
EUROPEAN ECONOMIC AREA
The European Economic Area includes the 27 European Union member states plus Iceland, Liechtenstein, and Norway.
EUROPEAN ECONOMIC COMMUNITY
The European Economic Community, also referred to as the European Community, has now become part of the European Union.
EUROPEAN FREE TRADE ASSOCIATION
The European Free Trade Association is a free trade organization between four European countries (Iceland, Liechtenstein, Norway, and Switzerland) that operates parallel to the European Union.
EUROPEAN STANDARDS
European standards (ENs) are documents that have been ratified by one of the three European standardization organizations (CEN, CENELEC, or ETSI) recognized as competent in the area of voluntary technical standardization as for the EU Regulation 1025/2012.
EUROPEAN UNION
The European Union is an economic and political union of 27 member states.
EUDAMED
EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
F
FALSIFIED DEVICE
A falsified device has 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 noncompliance and is without prejudice to infringements of intellectual property rights.
FDA ESTABLISHMENT IDENTIFIER
The FEI number is a unique identifier assigned by the FDA to identify firms associated with FDA regulated products.
FIELD SAFETY CORRECTIVE ACTION
Field safety corrective action is corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market.
FIELD SAFETY NOTICE
A field safety notice is a communication sent by a manufacturer to users or customers in relation to a field safety corrective action.
FOOD AND DRUG ADMINISTRATION
The Food and Drug Administration (FDA) is a U.S. government agency established in 1906 with the passage of the Federal Food and Drugs Act. The agency is separated into divisions that oversee a majority of the organization’s obligations involving food, drugs, cosmetics, animal food, dietary supplements, medical devices, biological goods, and blood products.
FULLY REFURBISHING
Fully refurbishing, for the purposes 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 this Regulation, combined with the assignment of a new lifetime to the refurbished device.
G
GENERIC DEVICE GROUP
A generic device group is 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.
GOOD CLINICAL PRACTICE
Good Clinical Practice (GCP) is defined as a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials.
GOOD MANUFACTURING PRACTICE
Good Manufacturing Practices (GMP, also referred to as cGMP or current Good Manufacturing Practice) is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.
GOST
GOST standards are regional standards administered by the Euro-Asian Council for Standardization, Metrology and Certification (EASC).
H
HARM
Harm is the injury or damage to the health of people or damage to property or the environment.
HARMONISED STANDARD
A harmonised standard is a European standard developed by a recognised European Standards Organisation: CEN, CENELEC, or ETSI.
HAZARD
A hazard is a potential source of harm.
HEALTH CANADA
Health Canada is the department of the Government of Canada responsible for national health policy.
HEALTH INSTITUTION
Health institution means an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health.
I
IMPLANTABLE DEVICE
An implantable device is 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.
IMPORTER
Importer means any natural or legal person established within the EU that places a device from a third country on the EU market.
IN VITRO DIAGNOSTIC DEVICE DIRECTIVE
European Directive 98/79/EC, also known as the In Vitro Diagnostic Device Directive (IVDD), is the current regulatory standard for the market access, use, and market surveillance of in vitro diagnostic medical devices.
IN VITRO DIAGNOSTIC DEVICE REGULATION
Regulation (EU) 2017/746 (also known as the IVDR) details the essential requirements manufacturers and importers must meet to apply the CE marking and legally market or sell their in vitro diagnostic devices in the EU. The IVDR entered into force on May 25, 2017, and will replace the IVDD on May 26, 2022.
IN VITRO DIAGNOSTIC MEDICAL DEVICE
An in vitro diagnostic medical device is any medical device that 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 a physiological or pathological process or state, a congenital physical or mental impairments, the predisposition to a medical condition or a disease, to determine the safety and compatibility with potential recipients, to predict treatment response or reactions, or to define or monitor therapeutic measures.
INCIDENT
An incident is any malfunction or deterioration in the characteristics or performance of a device made available on the market, including user error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side effect.
INJUNCTION
An injunction is a civil judicial process initiated by the FDA to stop or prevent violation of the law, such as to halt the flow of violative products in interstate commerce, and to correct the conditions that caused the violation to occur.
INSTRUCTIONS FOR USE
Instructions for use (IFU) are 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.
INFORMED CONSENT
Informed consent means 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.
INTENDED PURPOSE
The intended purpose is 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.
INTEROPERABILITY
Interoperability is the ability of two or more devices, including software, from the same manufacturer or from different manufacturers, to exchange information and use it for the execution of a specific function, communicate with each other, or work together as intended.
INTERVENTIONAL CLINICAL PERFORMANCE STUDY
An interventional clinical performance study is a clinical performance study where the test results may influence patient management decisions and/or may be used to guide treatment.
INVASIVE DEVICE
An invasive device is any device that, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body.
INVESTIGATIONAL DEVICE
An investigational device is a device that is assessed in a clinical investigation.
INVESTIGATIONAL DEVICE EXEMPTION
An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data, typically to support a premarket approval application of 510(k).
INDICATION
The term is often used in the medical device industry to refer to the specific condition, disease, or clinical situation for which a medical device is intended to be used, according to the manufacturer’s specifications. This provides more information on the patient population’s clinical status and expected clinical benefit.
INVESTIGATOR
An investigator is an individual responsible for the conduct of a clinical investigation at a clinical investigation site.
ISO 13485
ISO 13485 is the standard designed to be used by organizations involved in the design, production, installation, and servicing of medical devices and related services.
ISO 14971
ISO 14971 is the standard designed for risk management and corresponding general aspects for medical devices.
ISO 9001
ISO 9001 is defined as the international standard that specifies requirements for a quality management system. Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements.
L
LABEL
The label is the written, printed, or graphic information appearing either on the device itself, on the packaging of each unit, or on the packaging of multiple devices.
LABELLING
Labelling is all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers or accompanying such article at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce. The term “accompanying” is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, fillers, and so on. “Accompanying” also includes labelling that is brought together with the device after shipment or delivery for shipment in interstate commerce.
LAY PERSON
Lay person means an individual who does not have the formal education in a relevant field of healthcare or medical discipline.
LIFE CYCLE
The life cycle is the series of all phases in the life of a medical device from the initial conception to final decommissioning and disposal.
M
MAKING AVAILABLE ON THE MARKET
Making available on the market means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge.
MANUFACTURER
Manufacturer means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured, or fully refurbished, and markets that device under its name or trademark.
MARKET SURVEILLANCE
Market surveillance refers to the activities carried out and measures taken by competent authorities to ensure that devices comply with the requirements set out in the relevant EU harmonization legislation and do not endanger health, safety, or any other aspect of public interest protection.
MDA/MDN code
Code from MDCG 2021-17 guidance that is applied by your Notified Body as your sign your MDR Assessment contract. MDA/MDN pertains to device design and intended purpose; to be used for allocation of staff to review device technical documentation. These codes may target either a field of medical application or a device’s physical/technological principles. .
MDS code
Code from MDCG 2021-17 guidance that is applied by your Notified Body as your sign your MDR assessment contract. MDS is applicable to devices with specific characteristics; used for allocation of staff for technical documentation reviews as well as for auditing special processes in some cases.
MDT code
Code from MDCG 2021-17 guidance that is applied by your Notified Body as your sign your MDR Assessment contract. MDT is applicable to technologies and processes related to manufacturing of devices; used for allocation of manufacturing site auditors. MDT code assignment should be based on production processes for the device itself as well as upstream production processes.
MEDICAL DEVICE ESTABLISHMENT LICENSE
Issued by Health Canada, a Medical Device Establishment Licence is separate from a Medical Device Licence and is issued for the activities of importing and selling medical devices for human use in Canada.
MEDICAL DEVICE
A medical device is any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used—alone or in combination—for medical purposes in patients for diagnosis, prevention, monitoring, prediction, prognosis, therapy, treatment, or surgery.
MEDICAL DEVICE DIRECTIVE
Implemented in 1993, the Medical Device Directive (MDD) is Council Directive 93/42/EEC concerning medical devices. The MDD was replaced by the Medical Device Regulation in 2017.
MEDICAL DEVICE REGULATION
The Medical Device Regulation (MDR) is Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. This is the current regulation for medical devices in the EU.
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY
The Medicines and Healthcare Products Regulatory Agency regulates medicines, medical devices, and blood components for transfusion in the U.K.
N
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.
NATIONAL HEALTH SURVEILLANCE AGENCY
The National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) is an authority linked to the Brazilian National Health System’s Ministry of Health as the coordinator of the Brazilian Health Regulatory System (SNVS). The organization’s role is to promote the protection of the population’s health by executing sanitary control of the production, marketing, and use of products and services subject to health regulation, including related environments, processes, ingredients, and technologies, as well as the control in ports, airports, and borders.
NEGATIVE PREDICTIVE VALUE
Negative predictive value is the ability of a device to separate true negative results from false negative results for a given attribute in a given population.
NON CONFORMITY
A non-conformity is defined as a deviation from a specific procedure, standard, stated process, or system requirement. The ISO 13485 covers all phases of the medical device lifecycle and one that must be covered is also the control of nonconforming products. It’s a product or a medical device that does not fulfil its specified requirements like customer or regulatory requirements it’s considered a non-conformity.
NON CONFORMITY REPORT
A non-conformity report (NCR) can be either an internal report after an internal audit or QA findings, or an external report due to a Notified body audit.
NON VARIABLE
Non variable means having no potential for metabolism or multiplication.
NOTIFIED BODY
In the European Union, a notified body is an organization that has been accredited by a member state to assess whether a product meets certain standards. Assessment can include inspection and examination of a product, its design, and manufacturing processes.
MedTech Glossary
Look up MedTech regulatory terminology and definitions for EU MDR, IVDR and FDA
P
PARTICLE
For the purposes of the definition of nanomaterial in point (18), means a minute piece of matter with defined physical boundaries.
PERFORMANCE
Performance means the ability of a device to achieve its intended purpose as stated by the manufacturer.
PERFORMANCE EVALUATION
A performance evaluation is an assessment and analysis of data to establish or verify the scientific validity, the analytical and—where applicable—the clinical performance of a device.
PERFORMANCE EVALUATION PLAN
Under EU IVDR, manufacturers shall establish and update a performance evaluation plan to plan, continuously conduct, and document a performance evaluation. The performance evaluation plan shall specify the characteristics and the performance of the device and the process and criteria applied to generate the necessary clinical evidence. The performance evaluation shall be thorough and objective, considering both favourable and unfavourable data. As a general rule, the performance evaluation plan shall include: a specification of the intended purpose of the device; a specification of the characteristics of the device; a specification of the analyte or marker to be determined by the device; a specification of the intended use of the device; identification of certified reference materials or reference measurement procedures to allow for metrological traceability; a clear identification of specified target patient groups with clear indications, limitations and contraindications; an identification of the general safety and performance requirements that require support from relevant scientific validity and analytical and clinical performance data; a specification of methods, including the appropriate statistical tools, used for the examination of the analytical and clinical performance of the device and of the limitations of the device and information provided by it; a description of the state of the art, including an identification of existing relevant standards, CS, guidance, or best practices documents; an indication and specification of parameters to be used to determine, based on the state of the art in medicine; the acceptability of the benefit-risk ratio for the intended purpose or purposes and for the analytical and clinical performance of the device; for software qualified as a device, an identification and specification of reference databases and other sources of data used as the basis for its decision making; and an outline of the different development phases including the sequence and means of determination of the scientific validity, the analytical and clinical performance, including an indication of milestones and a description of potential acceptance criteria. Where any of the abovementioned elements are not deemed appropriate in the performance evaluation plan due to the specific device characteristics, a justification shall be provided in the plan.
PERFORMANCE EVALUATION REPORT
Under EU IVDR, the clinical evidence shall be documented in a performance evaluation report. This report shall include the scientific validity report, the analytical performance report, the clinical performance report, and an assessment of those reports allowing demonstration of the clinical evidence. The performance evaluation report shall, in particular, include: the justification for the approach taken to gather the clinical evidence; the literature search methodology and the literature search protocol and literature search report of a literature review; the technology on which the device is based, the intended purpose of the device and any claims made about the device’s performance or safety; the nature and extent of the scientific validity and the analytical and clinical performance data that has been evaluated; the clinical evidence as the acceptable performances against the state of the art in medicine; and any new conclusions derived from PMPF reports in accordance with Part B of this Annex.
PERFORMANCE STUDY
A performance study is a study undertaken to establish or confirm the analytical or clinical performance of a device.
PERFORMANCE STUDY PLAN
A performance study plan is a document that describes the rationale, objectives, design methodology, monitoring, statistical considerations, organization, and conduct of a performance study.
PERIODIC SAFETY UPDATE REPORT
Under MDR and IVDR, manufacturers shall prepare a periodic safety update report (PSUR) for each device summarizing the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan together with a rationale and description of any preventive and corrective actions taken. Throughout the lifetime of the device concerned, that PSUR shall set out the conclusions of the benefit-risk determination, the main findings of the PMCF/PMPF, and the volume of sales of the device and an estimate evaluation of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device.
PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE
Article 15 of the EU MDR and EU IVDR requires manufacturers to have at least one person responsible for regulatory compliance (PRRC) available within the organization to ensure the company meets the requirements of the MDR/IVDR.
PHARMACEUTICALS AND MEDICAL DEVICES AGENCY
Pharmaceuticals and Medical Devices Agency (PMDA) is the Japanese regulatory agency, working together with the Ministry of Health, Labour, and Welfare.
The organization’s role is to ensure the safety, efficacy, and quality of pharmaceuticals and medical devices through scientific reviews of marketing authorization applications for pharmaceuticals and medical devices, and monitoring post-marketing safety.
PLACING ON THE MARKET
Placing on the market means the first making available of a device, other than an investigational device, on the Union market.
POSITIVE PREDICTIVE VALUE
Positive predictive value is the ability of a device to separate true positive results from false positive results for a given attribute in a given population.
POST-MARKET CLINICAL FOLLOW-UP
Under MDR, post-market clinical follow-up (PMCF) is a continuous process that updates the clinical evaluation and shall be addressed in the manufacturer’s post-market surveillance (PMS) plan.
POST-MARKET PERFORMANCE FOLLOW-UP
Under IVDR, post-market performance follow-up (PMPF) is a continuous process that updates the performance evaluation and shall be addressed in the manufacturer’s post-market surveillance (PMS) plan.
POST-MARKET SURVEILLANCE
Post-market surveillance refers to 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.
POST-PRODUCTION
Post-production is part of the life cycle of a medical device after the design has been completed and the medical device has been manufactured.
PREDICTIVE VALUE
Predictive value is 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.
PREMARKET APPROVAL
Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.
PROCEDURE PACK
A procedure pack is a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose.
PUTTING INTO SERVICE
Putting into service means the stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose.
Q
QUALITY ASSURANCE
Quality assurance is the maintenance of a desired level of quality in a product, especially by means of attention to every stage of the process of delivery or production.
QUALITY MANAGEMENT SYSTEM
A quality management system (QMS) is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
QUALIFIED PERSON
The legal basis for the qualified person (QP) is defined in the Directive 2001/83/EC of the European Parliament and of the Council on the Community Code Relating to Medicinal Products for Human Use. In Article 48, Directive 2001/83 requests that EU member states have to assure that each holder of a manufacturing authorization has to have at least one QP who meets the defined requirements.
R
REASONABLY FORESEEABLE MISUSE
Reasonably foreseeable misuse is the use of a product or system in a way not intended by the manufacturer, but which can result from readily predictable human behaviour.
RECALL
A recall is any measure aimed at achieving the return of a device that has already been made available to the end user.
RECALL, CLASS I
This is the FDA classification for dangerous or defective products that predictably could cause serious health problems or death.
RECALL, CLASS II
This is the FDA classification for products that might cause a temporary health problem or pose only a slight threat of a serious nature.
RECALL, CLASS III
This is the FDA classification for products that are unlikely to cause any adverse health reaction but that violate FDA labelling or manufacturing laws.
REGULATORY AFFAIRS
Regulatory affairs (RA), also known as government affairs, is a profession within regulated industries, which includes pharmaceuticals and medical devices. Regulatory affairs professionals are typically responsible for ensuring companies comply with all relevant regulations and laws, working with federal, state, and local regulatory agencies on issues affecting their business, and advising companies on the regulatory aspects that would affect proposed activities.
REGISTERED CERTIFICATION BODY
In Japan, registered certification bodies (RCBs) are private certification bodies—similar to notified bodies in the EU—that monitor manufacturers and are authorized to perform third-party audits.
REPROCESSING
Reprocessing means a process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the technical and functional safety of the used device.
RESIDUAL RISK
Residual risk is the risk remaining after risk control measures have been implemented.
RISK
Risk means the combination of the probability of occurrence of harm and the severity of that harm.
RISK ANALYSIS
Risk analysis is the systematic use of available information to identify hazards and to estimate the risk.
RISK ASSESSMENT
Risk assessment is the overall process comprising a risk analysis and a risk evaluation.
RISK CONTROL
Risk control is a process in which decisions are made and measures implemented by which risks are reduced to, or maintained within, specified levels.
RISK ESTIMATION
Risk estimation is a process used to assign values to the probability of occurrence of harm and the severity of that harm.
RISK EVALUATION
Risk evaluation is the process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk.
RISK MANAGEMENT
Risk management is the systematic application of management policies, procedures, and practices to the tasks of analysing, evaluating, controlling, and monitoring risk.
RISK MANAGEMENT FILE
A risk management file is the set of records and other documents that are produced by risk management.
S
SAFETY CONCERN THRESHOLD
Threshold below 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. ISO10993-1:2018
SCIENTIFIC VALIDITY OF AN ANALYTE
Scientific validity of an analyte means the association of an analyte with a clinical condition or a physiological state.
SEIZURE
A seizure is an action brought against an FDA-regulated product because it is adulterated and/or misbranded. The purpose of such an action is to remove goods from commerce.
SERIOUS ADVERSE EVENT
A serious adverse event is any adverse event that led to death or serious deterioration in the health of the subject.
SERIOUS INCIDENT
A serious incident is any incident that directly or indirectly led, might have led, or might lead to death, temporary or permanent deterioration of health, or a serious public health threat.
SERIOUS PUBLIC HEALTH INCIDENT
Serious public health threat means an event which could result in imminent risk of death, serious deterioration in a person’s state of health, or serious illness, that may 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.
SINGLE-USE DEVICE
A single-use device is intended to be used on one individual during a single procedure.
SPONSOR
A sponsor is any individual, company, institution, or organization that takes responsibility for the initiation, management, and setting up of the financing of the clinical investigation.
STATE OF THE ART
State of the art is the developed stage of technical capability at a given time as regards products, processes, and services based on the relevant consolidated findings of science, technology, and experience.
SUMMARY OF SAFETY AND CLINICAL PERFORMANCE
Under MDR and IVDR, the manufacturer shall draw up a summary of safety and clinical performance (SSCP). The summary of safety and clinical performance shall be written in a way that is clear to the intended user and, if relevant, to the patient and shall be made available to the public via Eudamed. The draft of the summary of safety and clinical performance shall be part of the documentation to be submitted to the notified body involved in the conformity assessment. After its validation, the notified body shall upload the summary to Eudamed. The manufacturer shall mention on the label or instructions for use where the summary is available.
SUBJECT
A subject is an individual who participates in a clinical investigation.
SUMMARY TECHNICAL DOCUMENT
Created by the Global Harmonization Task Force (GHTF), a summary technical document (STED) is a standardized format for submitting information for regulatory approval of new devices.
SYSTEM
A system is a combination of products, either packaged together or not, which are intended to be interconnected or combined to achieve a specific medical purpose.
T
TECHNICAL DOCUMENTATION
To be in compliance with the EU MDR and IVDR, manufacturers must produce technical documentation that provides evidence of conformity with the relevant legislation before placing a medical device on the European market.
THERAPEUTIC GOODS ADMINISTRATION
The Therapeutic Goods Administration (TGA) is Australia’s regulatory authority for therapeutic goods. The organization performs a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard with the aim of ensuring that the Australian community has access, within a reasonable time, to therapeutic advances.
TOXICOLOGICAL RISK ASSESSMENT
Act of determining the potential of a chemical to elicit an adverse effect based on a specified level of exposure. ISO10993-1:2018
U
UNIQUE DEVICE IDENTIFIER
A unique device identifier (UDI) is a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards that allows unambiguous identification of specific devices on the market.
U.S. AGENT
Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (U.S. agent) for that establishment to act as a contact liaison with the U.S. FDA. A U.S. agent must be a resident of the United States or maintain a place of business in the U.S.
USER
User means any healthcare professional or layperson who uses a device.
V
VALIDATION
Used in quality controls, validation is the verification that a process consistently meets the requirements and leads to the expected results.
VERIFICATION
Verification is confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.
W
WARNING LETTER
The FDA issues a warning letter to notify the industry about violations that have been documented during inspections or investigations.
WITHDRAWAL
Withdrawal is any measure aimed at preventing a device in the supply chain from being further made available on the market.
Abbreviations Used in the Medical Device and In Vitro Diagnostics Industries
ACE
Adverse Clinical Event
ACT
Applied Clinical Trials
AET
Analytical Evaluation Threshold
AFSSAPS
Agence Française de Sécurité Sanitaire des Produits de Santé (France)
AIMDD
Active Implantable Medical Device Directive
ANSI
American National Standards Institute
ANVISA
Agência Nacional de Vigilância Sanitária (Portugal)
ASL
Approved Supplier List
ASQC
American Society for Quality Control
BEF
Biocompatibility Evaluation File (ISO 10993)
BEP
Biocompatibility Evaluation Plan (ISO 10993)
BER
Biocompatibility Evaluation Report (ISO 10993)
BOM
Bill of Materials
BSI
British Standards Institute
CA
Competent Authority
CAPA
Corrective and Preventive Action
CAR
Corrective Action Request or Corrective Action Record
CBER
Center for Biologics Evaluation and Research (United States)
CDC
Centers for Disease Control & Prevention (United States)
CDP
Clinical Development Plan
CDER
Center for Drug Evaluation and Research (United States)
CDRH
Center for Devices and Radiological Health (United States)
CEN
Comité européen de normalisation (European Committee for Standardization)
CEP
Clinical Evaluation Plan
CER
Clinical Evaluation Report
CFR
Code of Federal Regulations (United States)
CFSAN
Center for Food Safety and Applied Nutrition (United States)
CFU
Colony Forming Unit (used in Gamma validation)
cGMP
Current Good Manufacturing Practices
cGMPR
Current Good Manufacturing Practice Regulations
CIP
Clinical Investigation Plan (ISO 14555)
CIR
Clinical Investigaiton Report (ISO 14555)
CMDCAS
Canadian Medical Devices Conformity Assessment System
CMDR
Canadian Medical Device Regulation
CR
Change Request
CRF
Change Request Form
CRO
Contract Research Organization
cGLP
Current Good Laboratory Practice (United States)
CS
Common Specifications
CSR
Customer Service Representative
DCMS
Design Change Master Sheet
DCT
Decentralised Clinical Trials (ISO 14155 in terms of clinical investigations)
DHF
Device History File
DHHS
Department of Health and Human Services (United States)
DHR
Device History Record
DIMDI
Deutsches Institut für Medizinische Dokumentation und Information (Germany)
DIMS
Design Input Master Sheet
DMP
Data Management Plan (ISO 14155)
DMR
Data Management Report (ISO 14155)
DMR
Device Master Record
DoA
Date of Application
DRG
Diagnosis Related Group
DRMS
Design Review Master Sheet
DTC
Design Transfer Checklist
DVerMS
Design Verification Master Sheet
DVMS
Design Validation Master Sheet
eConsent
Electronic Consent (ISO 14155 in terms of clinical investigations)
EDC
Electronic Data Capture (ISO 14155 in terms of clinical investigations)
EDMA
European Diagnostic Manufacturers Association
EEA
European Economic Area
EEC
European Economic Community
EFTA
European Free Trade Association
eIFU
Electronic Instructions For Use
EMC
Electromagnetic Compatibility
EOL
End of Life
Electronic Patient Reported Outcomes (ISO 14155 in terms of clinical investigations)
EU
European Union
EUCOMED
European Confederation of Medical Associations
EUDAMED
European Database on Medical Devices
FDA
Food and Drug Administration (United States)
FMEA
Failure Mode and Effects Analysis
FOIA
Freedom of Information Act (United States)
FTA
Fault Tree Analysis
GCP
Good Clinical Practice
GHTF
Global Harmonization Task Force
GMP
Good Manufacturing Practice
IB
Investigation Brochure (ISO 14555)
IDE
Investigational Device Exemption
IFU
Instructions For Use
IMDRF
International Medical Device Regulators Forum (hwww.imdrf.org/documents)
IVD
In Vitro Diagnostic
IVDD
In Vitro Diagnostic Device Directive
IVDD
In Vitro Diagnostic Device Regulation
MDD
Medical Device Directive
MDEL
A Medical Device Establishment License
MDMA
Medical Device Manufacturers Association
MDR
Medical Device Regulation (EU)
MDR
Medical Device Report (United States)
MDUFMA
Medical Device User Fee and Modernization Act of 2002 (United States)
MDV
Medical Device Vigilance (EU)
MHRA
The Medicines and Healthcare products Regulatory Agency (United Kingdom)
MPR
Medical Problem Report (Canada)
MR
Management Representative
MSDS
Material Safety Data Sheet
NCR
Non-Conformance Report
NIH
National Institutes of Health (United States)
NAI
No Action Indicated
NPRA
New Product Risk Assessment
OAI
Official Action Indicated
OSHA
Occupational Safety and Health Administration (United States)
OTC
Over the Counter
PEP
Performance Evaluation Plan
PER
Performance Evaluation Report
PMA
Premarket Approval
PMCF
Post-Market Clinical Follow-Up
PMDA
Pharmaceutical and Medical Devices Agency
PMPF
Post-Market Performance Follow-Up
PMS
Post-Market Surveillance
PO
Purchase Order
PRMS
Product Requirements Master Sheet
PRRC
Person Responsible for Regulatory Compliance
PSP
Performance Study Plan
PSUR
Periodic Safety Update Report
QA
Quality Assurance
QMS
Quality Management System
QP
Qualified Person
QPM
Quality Policy Manual
QSP
Quality System Procedure
QSR
Quality System Regulations
RA
Return Authorization. Can also refer to “Regulatory Affairs.”
RMA
Risk Management Analysis
RMF
Risk Management File
RMP
Risk Management Plan
RMR
Risk Management Report
SaMD
Software as a Medical Device (ISO 14555)
SAP
Statistical Analysis Plan (ISO 14555)
SCT
Safety Concern Threshold
SOP
Standard Operating Procedure
SRW
Shipping Receiving Warehouse
SSCP
Summary of Safety and Clinical Performance
STED
Summary Technical Document
TGA
Therapeutic Goods Administration (Australia)
TRA
Toxicological Risk Assessment (ISO 10993-17 and ISO 14971:2019)
UDI
Unique Device Identifier
UEF
Usability Evaluation File (ISO 62366)
UEP
Usability Evaluation Plan (ISO 62366)
UER
Usability Evaluation Report (ISO 62366)
USP
United States Pharmacopoeia
VAI
Voluntary Action Indicated
VMF
Validation Management File
VMP
Validation Master Plan
VMR
Validation Master Report
WHO
World Health Organization
WI
Work Instructions
WTO
World Trade Organization
