ISO 13485 - Chapter 3

Original text

Expert opinion

For the purposes of this document, the terms and definitions given in ISO 9000:2015 and the following apply.
 
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: Issuance of an advisory notice can be required to comply with applicable regulatory requirements.
Based on ISO 9000:2015, terms are inherited and additional terms are defined specific to the nature of the quality management system for medical devices.
 
The term advisory notice defines some advise and supplementary information in the use of a medical device other than information represented in the Instructions for Use, of a modification of a medical device, return and/or desctruction instructions.
 
Some member states do require advisory notices to be issued in order to claim compliance to local regulations.

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]
Authorized representatives, marked by EC REP, do act on behalf of the manufacturer in the EU and have to represent the manufacturer. In this case, the EC REP further is responsible for the product placed on the EU market.
The Standard demands that such a mandate is given in writing.
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]
Clinical evaluation is the written procedure to discuss both favourable as well as un-favourable clinical data.
Clinical data should only be taken into account for the intended use as defined by the manufacturer and off-label use data should not be represented in the evaluation.
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: This definition of “complaint” differs from the definition given in ISO 9000:2015.
A complaint is any received feedback on a product or service that can be understood as a deficiency of the listed characteristics.
 
Please be adviced that any feedback received should be evaluated whether it qualifies for a complaint. Sources of feedback can be anyting, e.g. a feedback from a friend over the weekend regarding the performance of an implant, an email from a patient asking about the name of a product which is illegible on the label, a feedback on a post of the manufacturer in social media, etc.
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: More than one distributor may be involved in the supply chain.
 
Note 2: 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]
Distributor are any company or person that distributes a medical device in the market. Noteworthy here is, that a company or person only qualifies for a distributor if the distribution is done in its own behalf and not on behalf of another person or company.
 
Thus, any transportation company or parcel service is not understood as distributors unless they “sell” the medical device in its own name.
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: This definition of implantable medical device includes active implantable medical device.
Any medical device which is fully or partially implanted into the human body is understood as an implantable medical device. There is no difference for the sake of the term whether the implantation is done surgically or via a body orifice.
In addition to these products, replacement of ephithelial or eye surface is understood as an implant as well.
Please note that the products above have to remain in the body for at least 30 days to qualify for an implant.
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].
Importer is any company or person that imports a medical device for the first time into the market. Noteworthy here is, that a company or person only qualifies for an importer if not marketed or otherwise modified. Thus, importers physically bring the product into the market, but not legally.
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]
Labelling is the entirety of the information provided to the user on, in or about the medical device. Excluded from that are commercial documentation, such as invoices, shipping documentation or border declarations.
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]
The entire life span of a medical device is understood to coin the term life-cycle. Please note that conception and disposal of the medical device are phases as well and must be included and defined in the life-cycle.
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: 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.
[SOURCE: GHTF/SG1/N055:2009, 5.1]

The manufacturer is any company or person that holds the following responsibilities:

  • Responsibility for the design and/or manufacturing of a medical device.
  • Markets the product under its name
  • Makes available for use under its name

 

The manufacturer is ultimately responsible for the medical device, even thought it has not been physically design or manufactured in its premisses.

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: 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]

The definition of a medical includes any physical or digital product which has an in-vitro use or physical mode of action with a specific medical purpose.

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

Same basic desing and characteristics in relation to the safe and effective use of the medical device provided by the same manufacturer can be grouped into a medical device family.

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.

The performance evaluation is used to verify by data that the intended use is achieved.

Only when the intended use can be achieved, the medical device might receive market approval.

3.14 post-market surveillance
 
systematic process to collect and analyse experience gained from medical devices that have been placed on the market

To monitor the performance and safety of a medical device on the market, surveillance of the product has to be carried out.

To fulfil this requirement, a written procedure has to be established and the experience gained on the market has to be collected and analyzed systematically.

3.15 product

 
result of a process
 

Note 1: 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: 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: This definition of “product” differs from the definition given in ISO 9000:2015.
[SOURCE: ISO 9000:20052, 3.4.2, modified]

To monitor the performance and safety of a medical device on the market, surveillance of the product has to be carried out.

To fulfil this requirement, a written procedure has to be established and the experience gained on the market has to be collected and analyzed systematically.

3.16 purchased product
 
product provided by a party outside the organization’s quality management system
 
Note: The provision of product does not necessarily infer a commercial or financial arrangement.

A purchased product is a product bought from a third party supplier. The third party is not belonging ot the same QMS.

3.17 risk
 
combination of the probability of occurrence of harm and the severity of that harm
 
Note: This definition of “risk” differs from the definition given in ISO 9000:2015.
[SOURCE: ISO 14971:2007, 2.16]

The definition for risk, which is the product of probability of occurence x severity of harm, differs from ISO 9000. This due to the fact, that ISO 14971 is the standard for risk mangement for medical devices and thus, applicable to this term and IOS 13485.

3.18 risk management
 
systematic application of management policies, procedures and practices to the tasks of analysing, evaluating, controlling and monitoring risk
[SOURCE: ISO 14971:2007, 2.22]
The entirety of analyzing, evaluating, controlling and monitoring risks is summarized under the term risk management.
For medical devices, all plans, evaluations and results are summarized in the risk management report, based on the risk management process.
3.19 sterile barrier system
 
minimum package that prevents ingress of microorganisms and allows aseptic presentation of the product at the point of use
[SOURCE: ISO 11607‑1:2006, 3.22]
For sterile medical devices, a barrier system must be available up to point of use. This because contamination with microorganisms can bear a harm to patients.

3.20 sterile medical device

medical device intended to meet the requirements for sterility
 
Note: The requirements for sterility of a medical device can be subject to applicable regulatory requirements or standards.
 
 
Some medical device can have the requirement for being delivered sterile to the point of use. Specifically, this is the case for implants and other medical devices crossing the dermis barrier and/or having an affect, if not sterile, on potential ingress of microorganisms.

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