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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.
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.
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.
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.
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).
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).
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.
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).
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.
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).
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 performance is the ability of a device to correctly detect or measure a particular analyte.
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.
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 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 is the term for the withdrawal of the United Kingdom from the European Union.
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 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 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 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.
Under MDR, manufacturers must establish and update a clinical evaluation plan, which 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.
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 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 is any systematic investigation involving one or more human subjects undertaken to assess the safety or performance of a device.
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 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 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.
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.
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 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.
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 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.
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 assessment means the process demonstrating whether the requirements of the MDR or IVDR relating to a device have been fulfilled.
Conformity assessment body means a body that performs third-party conformity assessment activities including calibration, testing, certification, and inspection.
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 is any action taken to eliminate the cause of a potential or actual nonconformity or other undesirable situation.
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.
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 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.
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.
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 is the ability of a device to identify the presence of a target marker associated with a particular disease or condition.
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 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 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.
A European authorized 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 means a manufacturer, an authorized representative, an importer, or a distributor.
The European Economic Area includes the 27 European Union member states plus Iceland, Liechtenstein, and Norway.
The European Economic Community, also referred to as the European Community, has now become part of the European Union.
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 (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.
The European Union is an economic and political union of 27 member states.
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.
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.
The FEI number is a unique identifier assigned by the FDA to identify firms associated with FDA regulated products.
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.
A field safety notice is a communication sent by a manufacturer to users or customers in relation to a field safety corrective action.
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.
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 (GCP) is defined as a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials.
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 standards are regional standards administered by the Euro-Asian Council for Standardization, Metrology and Certification (EASC).
Harm is the injury or damage to the health of people or damage to property or the environment.
A hazard is a potential source of harm.
Health Canada is the department of the Government of Canada responsible for national health policy.
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 means any natural or legal person established within the EU that places a device from a third country on the EU market.
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.
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.
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.
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.
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 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.
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 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.
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.
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.
An investigational device is a device that is assessed in a clinical investigation.
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).
An investigator is an individual responsible for the conduct of a clinical investigation at a clinical investigation site.
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 is the standard designed for risk management and corresponding general aspects for medical devices.
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.
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.
Labeling 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 labeling that is brought together with the device after shipment or delivery for shipment in interstate commerce.
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.
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 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.
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.
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.
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.
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.
The Medicines and Healthcare Products Regulatory Agency regulates medicines, medical devices, and blood components for transfusion in the U.K.
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 is the ability of a device to separate true negative results from false negative results for a given attribute in a given population.
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.
Performance means the ability of a device to achieve its intended purpose as stated by the manufacturer.
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.
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 favorable and unfavorable 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.
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.
A performance study is a study undertaken to establish or confirm the analytical or clinical performance of a device.
A performance study plan is a document that describes the rationale, objectives, design methodology, monitoring, statistical considerations, organization, and conduct of a performance study.
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.
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 (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.
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.
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.
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 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 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 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 (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.
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.
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.
A quality management system (QMS) is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
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.
Reasonable 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 behavior.
A recall is any measure aimed at achieving the return of a device that has already been made available to the end user.
This is the FDA classification for dangerous or defective products that predictably could cause serious health problems or death.
This is the FDA classification for products that might cause a temporary health problem or pose only a slight threat of a serious nature.
This is the FDA classification for products that are unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws.
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.
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.
Residual risk is the risk remaining after risk control measures have been implemented.
Risk means the combination of the probability of occurrence of harm and the severity of that harm.
Risk analysis is the systematic use of available information to identify hazards and to estimate the risk.
Risk assessment is the overall process comprising a risk analysis and a risk evaluation.
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 is a process used to assign values to the probability of occurrence of harm and the severity of that harm.
Risk evaluation is the process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk.
Risk management is the systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk.
A risk management file is the set of records and other documents that are produced by risk management.
Scientific validity of an analyte means the association of an analyte with a clinical condition or a physiological state.
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.
A serious adverse event is any adverse event that led to death or serious deterioration in the health of the subject.
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.
A single-use device is intended to be used on one individual during a single procedure.
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 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.
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.
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.
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.
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.
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.
A unique device identifier (UDI) is a unique numeric or alphanumeric code that generally consists of a device identifier, a mandatory, fixed portion of a UDI that identifies the labeler, and the specific version or model of a device.
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 means any healthcare professional or layperson who uses a device.
Used in quality controls, validation is the verification that a process consistently meets the requirements and leads to the expected results.
Verification is confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.
The FDA issues a warning letter to notify the industry about violations that have been documented during inspections or investigations.
Withdrawal is any measure aimed at preventing a device in the supply chain from being further made available on the market.
Adverse Clinical Event
Applied Clinical Trials
Agence Française de Sécurité Sanitaire des Produits de Santé (France)
Active Implantable Medical Device Directive
American National Standards Institute
Agência Nacional de Vigilância Sanitária (Portugal)
Approved Supplier List
American Society for Quality Control
Bill of Materials
British Standards Institute
Corrective and Preventive Action
Corrective Action Request or Corrective Action Record
Center for Biologics Evaluation and Research (United States)
Centers for Disease Control & Prevention (United States)
Center for Drug Evaluation and Research (United States)
Center for Devices and Radiological Health (United States)
Comité européen de normalisation (European Committee for Standardization)
Clinical Evaluation Plan
Clinical Evaluation Report
Code of Federal Regulations (United States)
Center for Food Safety and Applied Nutrition (United States)
Colony Forming Unit (used in Gamma validation)
Current Good Manufacturing Practices
Current Good Manufacturing Practice Regulations
Canadian Medical Devices Conformity Assessment System
Canadian Medical Device Regulation
Change Request Form
Contract Research Organization
Current Good Laboratory Practice (United States)
Customer Service Representative
Design Change Master Sheet
Device History File
Department of Health and Human Services (United States)
Device History Record
Deutsches Institut für Medizinische Dokumentation und Information (Germany)
Design Input Master Sheet
Device Master Record
Diagnosis Related Group
Design Review Master Sheet
Design Transfer Checklist
Design Verification Master Sheet
Design Validation Master Sheet
European Diagnostic Manufacturers Association
European Economic Area
European Economic Community
European Free Trade Association
European Confederation of Medical Associations
European Database on Medical Devices
Food and Drug Administration (United States)
Failure Mode and Effects Analysis
Freedom of Information Act (United States)
Fault Tree Analysis
Good Clinical Practice
Global Harmonization Task Force
Good Manufacturing Practice
Investigational Device Exemption
In Vitro Diagnostic
In Vitro Diagnostic Device Directive
In Vitro Diagnostic Device Regulation
Medical Device Directive
A Medical Device Establishment License
Medical Device Manufacturers Association
Medical Device Regulation (EU)
Medical Device Report (United States)
Medical Device User Fee and Modernization Act of 2002 (United States)
Medical Device Vigilance (EU)
The Medicines and Healthcare products Regulatory Agency (United Kingdom)
Medical Problem Report (Canada)
Material Safety Data Sheet
National Institutes of Health (United States)
No Action Indicated
New Product Risk Assessment
Official Action Indicated
Occupational Safety and Health Administration (United States)
Over the Counter
Performance Evaluation Plan
Performance Evaluation Report
Post-Market Clinical Follow-Up
Pharmaceutical and Medical Devices Agency
Post-Market Performance Follow-Up
Product Requirements Master Sheet
Person Responsible for Regulatory Compliance
Performance Study Plan
Periodic Safety Update Report
Quality Management System
Quality Policy Manual
Quality System Procedure
Quality System Regulations
Return Authorization. Can also refer to "Regulatory Affairs."
Standard Operating Procedure
Shipping Receiving Warehouse
Summary of Safety and Clinical Performance
Summary Technical Document
Therapeutic Goods Administration (Australia)
Unique Device Identifier
United States Pharmacopoeia
Voluntary Action Indicated
World Health Organization
World Trade Organization
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