Basic Terms in Medical Device Industry
We can’t emphasize enough how important is to understand the language of medical devices. To meet the requirements and the Regulations it’s essential to understand what is meant by keywords and phrases.
Standardized classification and nomenclature of medical devices will serve as a common language for recording and reporting medical devices across the whole health system at all levels of health care for a whole range of uses. This article will cover those most commonly used terms in the medical device world.
And let us start with the basic one!
A medical device is any device intended to be used for medical purposes down below you’ll find a complete description of it.
21 CFR Part 11
Title 21 CFR Part 11: of the Code of Federal Regulations. Deals with FDA guidelines on electronic records and electronic signatures. Commonly referred to as “Part 11,” it defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.
21 CFR part 820
21 CFR Part 820, also known as the Quality System Regulation QSR outlines Current Good Manufacturing Practice (CGMP) regulations that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices
510(K)
Application for clearance required by the FDA in order to market a medical device intended for human use, when a Premarket Approval (PMA) is not required. Also called a “premarket notification” (PMN).
BOM – Bill of Material
List of raw materials, components, and subassemblies that make a product.
CA – Conformity Assessment
In the EU conformity with required regulatory standards can be self-assessed or carried out by a Notified Body, depending on the classification of the device in question. Conformity Assessment must be successfully carried out before a CE marking can be awarded and a product sold in the EU.
CAPA – Corrective Action Preventive Action
CAPA requirement is the regulatory demands ensuring a developer has clearly documented procedures for correcting and preventing existing and future nonconformities in their products, processes, and QMS.
CE Marking – European Conformity Marking
A CE is a certification mark that indicates conformity with medical device standards for products sold within the European Economic Area. You cannot legally sell the device in the EU without this marking.
Clinical Trial
Clinical Trials are conducted to allow safety and efficacy data to be collected for health interventions (e.g., drugs, diagnostics, devices, therapy protocols). These trials can take place only after satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place.
Contract Manufacturer
It manufactures a finished device to another establishment’s specifications.
DHF – Design History File
A design history file is respiratory for all records that demonstrate how your medical device was developed in accordance with an approved design plan. ISO 13485 and the FDA require developers to maintain a DHF for each type of device in their portfolio.
DHR – Design History Record
A combination of records containing the entire production history of a finished medical device.
DMR – Device Master Record
A Device Master Record is a compilation of the instructions, drawings, documented specifications, labeling and packaging requirements that must be used to produce your medical device. It is the definitive instruction manual for the safe and effective production of your device.
De Novo process
It provides a pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device. De Novo classification is a risk-based classification process.
DQ – Design Qualification
Documented verification that the proposed design of the device is suitable for the intended purpose.
EU IVDR - In Vitro Device Regulation
The EU Medical Device regulation governs the development of general medical devices for sale in the European Area.
EU MDR – Medical Device Regulation
The EU MDR governs the development of general medical devices for sale in the European Area.
FDA
U.S. Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, medical devices, etc.
FMEA – Failure Mode Effects Analysis
FMEA is a structured approach to discovering potential failures that may exist within the design of a medical device product or process. It is a model used to prioritize potential defects of a medical device based on their severity, expected occurrence and likelihood of detection.
GMP - Good Manufacturing Practices
current GMP requirements for medical devices are incorporated into a quality system regulation. The quality system regulation includes requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices intended for human use. This action is necessary to add preproduction design controls and to achieve consistency with quality system requirements worldwide. This regulation sets forth the framework for device manufacturers to follow and gives them greater flexibility in achieving quality requirements.
Hazard Identification
Identification of potential conditions, events or circumstances that could lead to or contribute to an unplanned or undesirable event.
IFU – Instruction for Use
Information provided by the manufacturer to inform the device user of the medical device’s intended purpose and proper use and of any precautions to be taken.
IVD - In Vitro Diagnostic
In-Vitro diagnostics are tests that can detect diseases, conditions, or infections. Some tests are used in a laboratory or other health professional settings and other tests are for consumers to use at home.
IP – Intellectual Property
Intangible property is the result of creativity, such as patents, copyrights, designs, inventions, etc.
ISO 13485:2016
Standard that is recognized as Quality Management standard for medical device regulators around the world.
ISO 14971:2019
risk management system for medical devices that determine safety during the product life cycle.
MDD – Medical Device Directive
The abbreviation for the EU Medical Device Directive which is now being superseded. It was intended to harmonize the laws relating to medical devices within the European Union. The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.
MDF – Medical Device File
In ISO 13485, Medical Device Files are documents that include a description of design records, manufacturing processes, product specifications, device usage guides, quality measurement criteria, as well as, servicing and installation records and their guidelines. A medical device file must be kept for every device in your portfolio.
Medical Device
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component part, or accessory, which is – (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (2) intended for use in the diagnosis of a disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
NB – Notified Body
A notified body is an organization designated by an EU country to assess the conformity of certain medical devices. Notified Bodies carry out conformity assessment procedures set out in the legislation when a third party is required to do so.
Nonconformity
It’s the non-fulfillment of a specified requirement.
PMA – Premarket Approval
Premarket approval is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class lll medical device. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use.
PMS - Post-Market Surveillance
Medical device manufacturers, as well as other firms involved in the distribution of devices, must follow certain requirements and regulations once devices are on the market. These include such things as tracking systems, reporting of device malfunctions, serious injuries or deaths, and registering the establishments where devices are produced or distributed.
Quality Control
Activities intended to ensure a manufactured product meets acceptance criteria.
Quality Audit
It’s a systematic, independent examination of a manufacturer’s quality system that is performed at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures, that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives.
QMS – Quality Management System
A QMS formally documents the processes, procedures, and responsibilities for achieving quality policies and objectives in the development and management of your medical device. A QMS can be a paper-based or digital system.
Risk Analysis
The systematic use of available information to identify hazards and eliminate risk.
Risk Management Plan
A documented plan for the systematic application of management policies, procedures, and practices to the tasks of analyzing, controlling and monitoring risk.
SOP – Standard Operating Procedure
A detailed written instruction to achieve uniformity of the performance of a specific function.
Technical Documentation
The EU MDR and IVDR require ‘technical documentation’ to be maintained and auditable for every device in your portfolio. It can be used to prove that a product has been designed according to the requirements of a quality management system and the relevant regulation.
Verification
Verification is a process that is used to evaluate whether a product, service, or system complies with regulations, specifications, or conditions imposed at the start of a development phase.
Validation
Validation is used to provide assurance that an activity or phase has been completed in an acceptable manner and that the next activity or phase can begin. Encompasses verification and extends the assessment to address whether devices produced in accordance with the design actually satisfy user needs and intended uses.
Why Knowing Medical Terminology is Important
Understanding terminology in the medical device industry can improve your job performance or make you more competitive and allows all medical and regulatory professionals to understand each other and communicate effectively.