ISO 13485 2016 Definitions in Plain English

ISO 13485 2016 Medical Device Definitions

Advisory Notice - Authorized Representative - Clinical Evaluation

Complaint - Distributor - Implantable Medical Device - Importer - Labeling

Life-Cycle - Manufacturer - Medical Device - Medical Device Family

Performance Evaluation - Postmarket Surveillance - Purchased Product

Risk - Risk Management - Sterile Barrier System - Sterile Medical Device

We’ve translated both the ISO 13485 2016 and the ISO 9000 2015 definitions

into plain English in order to make them easier to understand. We include both

sets of definitions because the new ISO 13485 standard expects you to use both.

Advisory notice

Organizations often issue advisory notices after their medical devices have
been delivered. These advisory notices provide supplementary information
about the device or specify actions that should be taken. Advisory notices
discuss the use, modification, destruction, or return of medical devices.

Authorized representative

An authorized representative is a natural or legal person who has received
a written mandate from a manufacturer to represent or to act on its behalf
within specified legal jurisdictions in all relevant regulatory matters.

Clinical evaluation

A clinical evaluation uses clinical evidence to assess and to analyze
a medical device in order to verify that it is safe and performs properly
whenever it is used as intended by the manufacturer of that device.

Complaint

A complaint is a negative communication about a medical device that
has been placed on the market. Communications can be oral, written,
or electronic. They allege that a medical device has a deficiency.

Complaints can be about the safety of a medical device.
Complaints can be about the quality of a medical device.
Complaints can be about the identity of a medical device.
Complaints can be about the usability of a medical device.
Complaints can be about the reliability of a medical device.
Complaints can be about the durability of a medical device.
Complaints can be about the performance of a medical device.

Complaints may also allege that a related service, that affects
the use of a medical device, has a deficiency.

Complaints can be about the safety of a related service.

Complaints can be about the quality of a related service.

Complaints can be about the identity of a related service.

Complaints can be about the usability of a related service.

Complaints can be about the reliability of a related service.

Complaints can be about the durability of a related service.

Complaints can be about the performance of a related service.

Distributor

A distributor is any natural or legal person who furthers the availability
of a medical device to the end user. Distributors are part of the supply
chain and act on their own behalf.

Implantable medical device

An implantable medical device is a medical device that is partly or
totally inserted into the human body or a natural orifice or is used to
replace an epithelial surface or the surface of the eye and is expected
to stay in use for 30 days or more and can only be removed through
medical or surgical intervention.

Importer

An importer is any natural or legal person who is responsible for taking
a medical device that is manufactured in one jurisdiction and being the
first to make it available in another specified jurisdiction.

Labelling

Labelling (or labeling) is written, printed, graphic, or electronic information
that is used to identify or describe a medical device, to specify its purpose,
or to explain how it should be used. Labelling can be attached to medical
devices, containers, or wrappers, or it may simply accompany a medical
device or be provided for a device by other means.

Life-cycle

The life-cycle of a medical device includes all phases from initial
concept and design to production and post-production and includes
final decommissioning and disposal.

Manufacturer

In the context of this standard, a manufacturer is any natural or legal
person who is responsible for designing or manufacturing a medical
device and making it available for use under its own name. It doesn’t
matter whether that person actually designs or manufactures the
medical device or has someone else do it on their behalf; they’re
still the manufacturer under this definition.

Also, anyone who modifies a medical device or changes its intended
use and makes it available for use under its own name, without acting
on behalf of the original manufacturer, becomes the manufacturer
of the modified medical device. Furthermore, anyone who designs or
manufactures an accessory automatically becomes a manufacturer
under this definition if applicable medical device regulations apply
to this accessory.

The term medical device manufacturer may also include anyone
involved in specification development, production, fabrication,
assembly, processing, packaging (or repackaging), labelling
(or relabelling), sterilization, installation, or remanufacturing.
It may also include anyone who puts a collection of medical
devices (or other products) together for medical purposes.

Manufacturers have the legal responsibility to comply with all relevant
regulatory requirements in every country or jurisdiction that intends to
purchase or use their medical device (unless a Regulatory Authority
assigns this responsibility to someone else).

Medical device

Instruments, appliances, implements, implants, machines, software,
materials, calibrators, apparatuses, in vitro reagents, and any similar
or related articles are defined as medical devices if manufacturers
intend them to be used (alone or in combination) for one or more
of the following purposes:

To deal with human disease.
- To prevent human disease.
- To diagnose human disease.
- To treat human disease.
- To alleviate human disease.
- To monitor human disease.
To care for human injuries.
- To diagnose human injuries.
- To treat human injuries.
- To alleviate human injuries.
- To monitor human injuries.
- To compensate for human injuries.
To meet human anatomical needs.
- To investigate human anatomical issues.
- To replace human anatomical structures.
- To modify human anatomical structures.
- To support human anatomical structures.
To maintain human physiological functions.
- To investigate human physiological functions.
- To replace human physiological functions.
- To modify human physiological functions.
- To support human physiological functions.
To examine specimens taken from human bodies.
To disinfect human medical devices.
To support or sustain human life.
To control human conception.

Medical device family

A medical device family is a group of medical devices that share the
same basic design, have the same basic intended use and the same
basic safety and functional performance characteristics, and were
manufactured by or for the same organization.

Performance evaluation

In the context of this standard, a performance evaluation uses data
to assess and analyze an in vitro diagnostic medical device in order
to establish or verify that it can achieve its intended use.

Postmarket surveillance

Postmarket surveillance is a systematic process that is used to collect
and to analyze data about the experience people are having with medical
devices which have been placed on the market.

Purchased product

A purchased product is a product that was provided by someone

that is outside an organization's quality management system.

Risk

According to ISO 13485, when the term risk is used it refers to the need
to think about what could potentially happen when a manufacturer fails
to meet product safety or performance requirements or fails to comply
with applicable regulatory requirements. According to the ISO 14971 risk
management standard for medical devices, the concept of risk combines
two variables: the probability of harm and the severity of harm.

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Updated on April 17, 2021. First published on June 30, 2015.
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