Medical Device Regulatory Glossary

The FDA's Quality System Regulation (QSR) that establishes current Good Manufacturing Practice (cGMP) requirements for medical device manufacturers in the United States.

A premarket submission made to the FDA to demonstrate that a medical device is substantially equivalent to a legally marketed predicate device.

A public document summarizing the 510(k) substantial equivalence determination submitted to the FDA.

A streamlined FDA 510(k) submission pathway that relies on FDA guidance documents, special controls, or recognized consensus standards to demonstrate substantial equivalence.

Any undesirable experience associated with the use of a medical device, including patient harm, injury, malfunction, or near-miss incidents that must be reported to regulatory authorities.

Medical devices that incorporate artificial intelligence or machine learning algorithms to analyze data, support clinical decisions, or perform diagnostic functions.

A defined set of rules, calculations, or computational procedures used by medical device software to process input data and generate outputs for clinical purposes.

The Brazilian Health Regulatory Agency responsible for health product regulation, including medical devices, pharmaceuticals, and food safety.

A systematic, independent examination of a Quality Management System to determine whether quality activities and results comply with planned arrangements and whether these arrangements are implemented effectively.

A legal entity designated by non-EU manufacturers to act on their behalf for EU MDR compliance and serve as a point of contact with regulatory authorities.

A systematic evaluation comparing the clinical benefits of a medical device against its risks to determine acceptability for intended use.

The ability of a medical device material to perform with an appropriate host response in a specific application, without causing unacceptable adverse biological effects.

An FDA program designation for medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

A Brazilian legal entity required to hold medical device registrations on behalf of foreign manufacturers with ANVISA.

A systematic approach to investigating, correcting, and preventing quality problems in medical device manufacturing and operations.

The FDA center responsible for regulating medical devices and radiation-emitting products in the United States.

A mandatory conformity marking for medical devices sold in the European Economic Area, indicating compliance with EU health, safety, and environmental requirements.

A comprehensive document required under EU MDR that evaluates and documents clinical data to demonstrate a medical device's safety and performance.

A risk-based system for categorizing medical devices that determines the level of regulatory control and the pathway to market authorization.

A systematic study conducted on human subjects to assess the safety and performance of a medical device, required under EU regulations for certain devices before CE marking.

The Mexican Federal Commission for Protection Against Health Risks, responsible for regulating medical devices, pharmaceuticals, and food safety in Mexico.

National regulatory bodies in EU member states responsible for implementing and enforcing the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

A systematic process for receiving, reviewing, investigating, and responding to customer complaints about medical device quality, safety, or performance issues.

The systematic process under EU MDR to demonstrate that a medical device meets all applicable requirements and is safe and performs as intended.

The protection of medical devices from cyber threats and unauthorized access through systematic risk management, secure design principles, and ongoing vulnerability monitoring and mitigation.

An FDA regulatory pathway for novel, low-to-moderate risk medical devices that have no predicate device for 510(k) comparison.

A formal written statement by the manufacturer that a medical device meets all applicable EU MDR requirements and is ready for CE marking.

FDA requirements under 21 CFR 820.30 that establish procedures for controlling the design of medical devices to ensure they meet user needs and intended uses.

Testing and evidence that confirms a medical device meets user needs and intended uses under actual or simulated use conditions.

Testing and evidence that confirms design outputs meet design inputs through objective testing and analysis.

FDA requirement for manufacturers and initial distributors to list all medical devices they have in commercial distribution with the agency.

A compilation of records describing the design history of a finished medical device, required by FDA 21 CFR Part 820.

A broad category of technologies that use computing platforms, connectivity, software, and sensors to support healthcare and health-related applications.

An entity in the supply chain that makes medical devices available on the market without changing their intended purpose.

A compilation of records containing the complete manufacturing procedures and specifications for a finished medical device.

A legal entity established in the European Union appointed by a non-EU manufacturer to act on their behalf for regulatory matters under EU MDR.

Any natural or legal person in the medical device supply chain who is involved in making devices available on the market, including manufacturers, authorized representatives, importers, and distributors.

Requirements and testing standards to ensure medical electrical equipment does not present electrical hazards to patients, operators, or surroundings during normal use and fault conditions.

Testing to ensure medical devices do not emit harmful electromagnetic interference and can operate correctly in their intended electromagnetic environment without degradation of performance.

The European Union Medical Device Regulation (2017/745) that governs the approval, manufacturing, and post-market surveillance of medical devices in the EU.

An FDA emergency authorization pathway that allows unapproved medical products to be used during public health emergencies when no adequate approved alternatives exist.

The European Database on Medical Devices, a comprehensive EU-wide system for registration of economic operators, devices, certificates, clinical investigations, and vigilance reporting under EU MDR and IVDR.

The U.S. federal agency responsible for protecting public health by regulating food, drugs, medical devices, cosmetics, and other products.

A mandatory FDA requirement for all facilities involved in the production and distribution of medical devices intended for commercial distribution in the United States.

An action taken by a manufacturer to reduce a risk of death or serious deterioration in health associated with the use of a medical device that is already placed on the market.

A communication sent by a manufacturer to users and customers to inform them about a Field Safety Corrective Action (FSCA) being undertaken to reduce risks associated with a medical device.

An internationally recognized system for the accurate identification and classification of medical devices through standardized naming conventions and unique numeric codes.

A system of regulations, codes, and guidelines ensuring medical devices are consistently produced and controlled according to quality standards.

The process of aligning medical device regulatory requirements, standards, and procedures across different countries and regions to facilitate international trade and improve patient safety.

An FDA regulatory pathway for devices intended to benefit patients with rare diseases or conditions affecting fewer than 8,000 individuals per year in the United States.

Canada's federal health department responsible for regulating medical devices to ensure their safety, effectiveness, and quality for Canadian patients.

A United States federal law that establishes national standards for protecting sensitive patient health information from disclosure without patient consent or knowledge.

Singapore's national regulatory agency responsible for the registration, regulation, and surveillance of medical devices to ensure their safety, quality, and efficacy.

The scientific discipline focused on understanding human capabilities, limitations, and behaviors to optimize medical device design for safe and effective use.

The international standard that defines the lifecycle requirements for medical device software, including development, maintenance, risk management, and configuration management.

The international standard for health software product safety covering the entire lifecycle of standalone health software.

Instructions for Use - comprehensive documentation provided by the manufacturer that gives users the information necessary for safe and effective use of a medical device.

A natural or legal person who places a medical device from a third country onto the EU or US market, taking on specific regulatory responsibilities for compliance and post-market surveillance.

An FDA-specific term describing the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, along with the patient population for which the device is intended, required in 510(k) submissions.

The objective intent of the manufacturer regarding the use of a medical device, as reflected in specifications, instructions, and promotional materials, which determines regulatory classification and pathway.

A systematic, independent, and documented self-assessment process conducted by an organization to verify conformance of its quality management system to planned arrangements, regulatory requirements, and established procedures.

The ability of medical devices, systems, and software applications to exchange, interpret, and use health information to enable coordinated patient care.

Colombia's national regulatory agency responsible for the surveillance and control of medicines, medical devices, food, cosmetics, and other health-related products to protect public health.

The international standard for quality management systems specific to medical device organizations.

The international standard for the application of risk management to medical devices.

A medical device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening purposes.

The European Union regulation (EU 2017/746) that governs the safety and performance of in vitro diagnostic medical devices.

South Korea's Ministry of Food and Drug Safety, the regulatory authority responsible for medical device approval, registration, and post-market surveillance.

All written, printed, or graphic information appearing on the medical device, its packaging, or accompanying the device, including instructions for use and safety information.

A systematic and comprehensive search, appraisal, and analysis of published scientific and clinical literature to support clinical evaluation and demonstrate device safety and performance.

A periodic, systematic evaluation by top management of the quality management system to ensure its continuing suitability, adequacy, effectiveness, and alignment with the organization's strategic direction.

A mandatory report submitted to the FDA under 21 CFR Part 803 when a medical device may have caused or contributed to a death, serious injury, or experienced a malfunction that would be likely to cause or contribute to a death or serious injury if it were to recur.

A program that allows a single regulatory audit of a medical device manufacturer's quality management system to satisfy the requirements of multiple participating regulatory authorities.

The United Kingdom's regulatory authority responsible for ensuring that medicines and medical devices work and are acceptably safe, operating independently post-Brexit with the UKCA marking framework.

A mobile application that meets the definition of a medical device and is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.

China's national regulatory authority for drugs, medical devices, and cosmetics, formerly known as CFDA.

A failure to meet specified requirements in product design, manufacturing processes, quality management systems, or regulatory compliance within medical device operations.

An organization designated by an EU Member State to assess the conformity of medical devices before they are placed on the market.

Commercially available software components used in medical devices without modification by the device manufacturer.

An FDA regulatory mechanism that allows manufacturers of AI/ML-enabled medical devices to make pre-approved software modifications without submitting new marketing applications, provided changes fall within predetermined boundaries.

The FDA's most rigorous device marketing pathway, required for high-risk Class III medical devices to demonstrate safety and effectiveness.

A continuous process of collecting and evaluating clinical data for CE-marked medical devices to confirm safety and performance throughout the device lifecycle.

Japan's regulatory agency responsible for ensuring the safety, efficacy, and quality of pharmaceuticals and medical devices.

A proactive, systematic process to collect and analyze data about the performance and safety of medical devices after they are placed on the market.

A formal program allowing medical device manufacturers to obtain FDA feedback on regulatory, scientific, and clinical questions before submitting a 510(k), PMA, or De Novo application.

A legally marketed device used as a reference point for demonstrating substantial equivalence in a 510(k) premarket notification submission to the FDA.

Establishing documented evidence that a manufacturing process consistently produces a product that meets predetermined specifications and quality attributes.

An individual required by EU MDR to ensure a manufacturer's compliance with regulatory requirements.

A structured report summarizing post-market surveillance data for higher-risk medical devices, submitted periodically to the notified body under EU MDR Article 86.

A formalized system documenting processes, procedures, and responsibilities for achieving quality policies and objectives in medical device manufacturing.

The FDA's proposed Quality Management System Regulation that will align US medical device quality requirements with ISO 13485, replacing the current Quality System Regulation (QSR).

A corrective action taken to address a problem with a medical device that violates FDA law or could pose a risk to health, involving removal from the market or correction in the field.

The regulatory process of obtaining official authorization from a health authority to legally market and sell a medical device in a specific country or region.

A systematic process for identifying, analyzing, evaluating, and controlling risks associated with medical devices throughout their lifecycle to ensure patient and user safety.

Data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources outside of traditional clinical trial settings.

Software intended to be used for medical purposes that performs these purposes without being part of a hardware medical device.

The International Medical Device Regulators Forum (IMDRF) framework for classifying Software as a Medical Device based on the healthcare situation and significance of information provided to the healthcare decision.

A comprehensive, formally structured inventory of all software components, libraries, and dependencies used in a medical device, enabling transparency and management of software supply chain security and vulnerabilities.

Any malfunction or deterioration in characteristics or performance of a medical device, as well as any inadequacy in labeling or instructions that has led, or might have led, to death or serious deterioration in the state of health of a patient, user, or other person.

Software that is integral to a hardware medical device and cannot function independently from the device.

Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that particular requirements are consistently fulfilled.

Software that is already developed and generally available, whose provenance and development process are not directly controlled by the medical device manufacturer, but which is incorporated into a medical device.

A streamlined FDA 510(k) pathway for device modifications where the manufacturer uses design controls to demonstrate that design changes maintain substantial equivalence without raising new safety or effectiveness questions.

The developed stage of technical capability at a given time regarding products, processes, and services, based on the relevant consolidated findings of science, technology, and experience.

A validated process used to render medical devices free from viable microorganisms, ensuring patient safety for devices that contact sterile tissue or the vascular system.

The FDA's determination that a new medical device is as safe and effective as a legally marketed predicate device, based on comparison of intended use and technological characteristics.

Switzerland's regulatory agency for therapeutic products including medical devices, responsible for market authorization, post-market surveillance, and compliance enforcement.

A comprehensive set of documentation required by EU MDR that demonstrates a medical device meets safety and performance requirements, including design, manufacturing, and clinical evidence.

Australia's regulatory authority responsible for regulating therapeutic goods including medical devices, medicines, blood products, and biologicals to ensure they meet safety, quality, and performance standards.

FDA's comprehensive approach to regulating software and AI/ML-based medical devices throughout their entire lifecycle, from pre-market development through post-market monitoring and continuous improvement.

The ability to track and trace medical devices through the entire supply chain from manufacturing to end-user, enabling effective recalls, safety monitoring, and inventory management.

The systematic analysis and reporting of adverse event patterns and device malfunction trends that may indicate emerging safety issues, required by FDA and other regulators for proactive post-market surveillance.

A system to uniquely identify medical devices through distribution and use, using a standardized identifier on device labels and packages.

The systematic process of analyzing, designing, and evaluating user interfaces to minimize use errors and ensure medical devices are safe and effective for their intended users.

Confirmation through objective evidence that requirements for a specific intended use or application have been fulfilled.

Confirmation through objective evidence that specified requirements have been fulfilled.

The EU MDR system for reporting and investigating serious incidents and Field Safety Corrective Actions (FSCA) involving medical devices.

A formal enforcement action issued by the FDA notifying a company of serious violations of regulations, requiring corrective action within 15 business days.