3 Terms and definitions Flashcards
3.1
advisory notice
3.1
advisory notice
notice issued by the organization, subsequent to delivery of the medical device, to provide supplementary
information or to advise on action to be taken in the:
— use of a medical device,
— modification of a medical device,
— return of the medical device to the organization that supplied it, or
— destruction of a medical device
Note 1 to entry: Issuance of an advisory notice can be required to comply with applicable regulatory requirements.
3.2
authorized representative
3.2
authorized representative
natural or legal person established within a country or jurisdiction who has received a written mandate
from the manufacturer to act on his behalf for specified tasks with regard to the latter’s obligations
under that country or jurisdiction’s legislation
[SOURCE: GHTF/SG1/N055:2009, 5.2]
3.3
clinical evaluation
3.3
clinical evaluation
assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and
performance of the device when used as intended by the manufacturer
[SOURCE: GHTF/SG5/N4:2010, Clause 4]
3.4
complaint
3.4
complaint
written, electronic or oral communication that alleges deficiencies related to the identity, quality,
durability, reliability, usability, safety or performance of a medical device that has been released from
the organization’s control or related to a service that affects the performance of such medical devices
Note 1 to entry: This definition of “complaint” differs from the definition given in ISO 9000:2015.
3.5
distributor
3.5
distributor
natural or legal person in the supply chain who, on his own behalf, furthers the availability of a medical device to the end user
Note 1 to entry: More than one distributor may be involved in the supply chain.
Note 2 to entry: Persons in the supply chain involved in activities such as storage and transport on behalf of the manufacturer, importer or distributor, are not distributors under this definition.
[SOURCE: GHTF/SG1/N055:2009, 5.3]
3.6
implantable medical device
3.6
implantable medical device
medical device which can only be removed by medical or surgical intervention and which is intended to:
— be totally or partially introduced into the human body or a natural orifice, or
— replace an epithelial surface or the surface of the eye, and
— remain after the procedure for at least 30 days
Note 1 to entry: This definition of implantable medical device includes active implantable medical device
3.7
importer
3.7
importer
natural or legal person in the supply chain who is the first in a supply chain to make a medical device, manufactured in another country or jurisdiction, available in the country or jurisdiction where it is to be marketed
[SOURCE: GHTF/SG1/N055:2009, 5.4]
3.8
labelling
3.8
labelling
label, instructions for use, and any other information that is related to identification, technical description, intended purpose and proper use of the medical device, but excluding shipping documents
[SOURCE: GHTF/SG1/N70:2011, Clause 4]
3.9
life-cycle
3.9
life-cycle
all phases in the life of a medical device, from the initial conception to final decommissioning and disposal
[SOURCE: ISO 14971:2007, 2.7]
3.10
manufacturer
3.10
manufacturer
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 to entry: 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 to entry: 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 to entry: “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 to entry: 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 to entry: 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 to entry: 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 entry: 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.
[SOURCE: GHTF/SG1/N055:2009, 5.1]
3.11
medical device
3.11
medical device
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 to entry: 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.
[SOURCE: GHTF/SG1/N071:2012, 5.1]
3.12
medical device family
3.12
medical device family
group of medical devices manufactured by or for the same organization and having the same basic design and performance characteristics related to safety, intended use and function
3.13
performance evaluation
3.13
performance evaluation
assessment and analysis of data to establish or verify the ability of an in vitro diagnostic medical device to achieve its intended use
3.14
post-market surveillance
3.14
post-market surveillance
systematic process to collect and analyse experience gained from medical devices that have been placed
on the market
3.15
product
3.15
product
result of a process
Note 1 to entry: There are four generic product categories, as follows:
— services (e.g. transport);
— software (e.g. computer program, dictionary);
— hardware (e.g. engine mechanical part);
— processed materials (e.g. lubricant).
Many products comprise elements belonging to different generic product categories. Whether the product is then called service, software, hardware or processed material depends on the dominant element. For example, the offered product “automobile” consists of hardware (e.g. tyres), processed materials (e.g. fuel, cooling liquid), software (e.g. engine control software, driver’s manual), and service (e.g. operating explanations given by the
salesman).
Note 2 to entry: Service is the result of at least one activity necessarily performed at the interface between the
supplier and customer and is generally intangible. Provision of a service can involve, for example, the following:
— an activity performed on a customer-supplied tangible product (e.g. automobile to be repaired);
— an activity performed on a customer-supplied intangible product (e.g. the income statement needed to
prepare a tax return);
— the delivery of an intangible product (e.g. the delivery of information in the context of knowledge
transmission);
— the creation of ambience for the customer (e.g. in hotels and restaurants).
Software consists of information and is generally intangible and can be in the form of approaches, transactions
or procedures.
Hardware is generally tangible and its amount is a countable characteristic. Processed materials are generally
tangible and their amount is a continuous characteristic. Hardware and processed materials often are referred
to as goods.
Note 3 to entry: This definition of “product” differs from the definition given in ISO 9000:2015.
[SOURCE: ISO 9000:20052), 3.4.2, modified]
