Glossary

combination of all technical and associated administrative actions intended to retain an item at/or restore it to a state in which it can perform its required function

[ISO 17665-1:2006]

Note: Routine servicing is any regularly scheduled maintenance of a device, including the replacement of parts at the end of their normal life expectancy, e.g., calibration, replacement of batteries, and responses to normal wear and tear. Repairs of an unexpected nature, replacement of parts earlier than their normal life expectancy, or identical repairs or replacements of multiple units of a device are not routine servicing.

[FDA 21CFR806]

natural or legal person with responsibility for design and/or manufacture of a medical device with the intention of making the medical device available for use, under his name; whether or not such a medical device is designed and/or manufactured by that person himself or on his behalf by another person(s)

Note 1: This "natural or legal person" has ultimate legal responsibility for ensuring compliance with all applicable regulatory requirements for the medical devices in the countries or jurisdictions where it is intended to be made available or sold, unless this responsibility is specifically imposed on another person by the Regulatory Authority (RA) within that jurisdiction.
Note 2: The manufacturer’s responsibilities are described in other GHTF guidance documents. These responsibilities include meeting both pre-market requirements and post-market requirements, such as adverse event reporting and notification of corrective actions.
Note 3: "Design and/or manufacture", as referred to in the above definition, may include specification development, production, fabrication, assembly, processing, packaging, repackaging, labelling, relabelling, sterilization, installation, or remanufacturing of a medical device; or putting a collection of devices, and possibly other products, together for a medical purpose.
Note 4: Any person who assembles or adapts a medical device that has already been supplied by another person for an individual patient, in accordance with the instructions for use, is not the manufacturer, provided the assembly or adaptation does not change the intended use of the medical device.
Note 5: Any person who changes the intended use of, or modifies, a medical device without acting on behalf of the original manufacturer and who makes it available for use under his own name, should be considered the manufacturer of the modified medical device.
Note 6: An authorized representative, distributor or importer who only adds its own address and contact details to the medical device or the packaging, without covering or changing the existing labelling, is not considered a manufacturer.
Note 7: To the extent that an accessory is subject to the regulatory requirements of a medical device, the person responsible for the design and/or manufacture of that accessory is considered to be a manufacturer.

[ISO 13485:2016, ISO 14971:2019]

any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions

[FDA 21CFR820]

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

[EU MDR 2017/745, EU IVDR 2017/746]

any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedure. The term includes any person who either:
(1) Repackages or otherwise changes the container, wrapper, or labeling of a device in furtherance of the distribution of the device from the original place of manufacture;
(2) Initiates specifications for devices that are manufactured by a second party for subsequent distribution by the person initiating the specifications;
(3) Manufactures components or accessories that are devices that are ready to be used and are intended to be commercially distributed and intended to be used as is, or are processed by a licensed practitioner or other qualified person to meet the needs of a particular patient; or
(4) Is the U.S. agent of a foreign manufacturer.

[FDA 21CFR803]

[organization that] makes by chemical, physical, biological, or other procedures, any article that meets the definition of "device" in Section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act

[FDA website: Who Must Register...]

any material or substance used in or used to facilitate the manufacturing process, a concomitant constituent, or a byproduct constituent produced during the manufacturing process, which is present in or on the finished device as a residue or impurity not by design or intent of the manufacturer

[FDA 21CFR820]

a correction or removal of a distributed device that involves a minor violation of the act that would not be subject to legal action by FDA or that involves no violation of the act, e.g., normal stock rotation practices

[FDA 21CFR806]

synthetic or natural polymer, metal or alloy, ceramic, or composite, including tissue rendered non-viable, used as a medical device or any part thereof

[ISO 10993-1:2018]

instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific medical purpose(s) of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease;
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
- investigation, replacement, modification, or support of the anatomy or of a physiological process;
- supporting or sustaining life;
- control of conception,
- disinfection of medical devices;
- providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means

Note 1: Products which may be considered to be medical devices in some jurisdictions but not in others include:
- disinfection substances;
- aids for persons with disabilities;
- devices incorporating animal and/or human tissues;
- devices for in vitro fertilization or assisted reproduction technologies.

[ISO 13485:2016]

Note 2: Products which may be considered to be medical devices in some jurisdictions but not in others include:
— items specifically intended for cleaning or sterilization of medical devices;
— pouches, reel goods, sterilization wrap and reusable containers for packaging of medical devices for sterilization.

[ISO 11139:2018]

Note 3: Medical devices include dental devices.

[ISO 10993-1:2018]

any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: — diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, — diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, — investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, — providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

Note: The following products shall also be deemed to be medical devices:
— devices for the control or support of conception;
— products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.

[EU MDR 2017/745]

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 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. The term "device" does not include software functions excluded pursuant to section 360j(o) of this title.

[OLRC 21USC9]

file containing or referencing documents generated to demonstrate conformity to the requirement of this International Standard and compliance with applicable regulatory requirements

Note: The content of the file(s) shall include, but not limited to:
a) General description of the medical device, intended use/purpose, and labelling, including any instructions for use
b) specifications for product;
c) specifications or procedures for manufacturing, packaging, storage, handling and distribution;
d) procedures for measuring and monitoring;
e) as appropriate, requirements for installation;
f) as appropriate, procedures for servicing.

[ISO 13485:2016 derived]

report submitted to FDA of suspected device-associated deaths, serious injuries and/or malfunctions

[FDA website: Medical Device Reporting (MDR)...]

software system that has been developed for the purpose of being incorporated into the medical device being developed or that is intended for use as a medical device

Note: This includes a medical device software product, which then is a medical device in its own right.

[IEC 62304:2015]

system containing at least one medical device