FprCEN ISO/TR 20416

SLOVENSKI STANDARD
kSIST-TP FprCEN ISO/TR 20416:2020
01-april-2020
Medicinski pripomočki - Nadzor proizvajalcev po dajanju v promet (ISO/PRF TR
20416:2020)

Medical devices - Post-market surveillance for manufacturers (ISO/PRF TR 20416:2020)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Purpose of post-market surveillance process ....................................................................................................................... 2

5 Planning of post-market surveillance ............................................................................................................................................ 3

5.1 General ........................................................................................................................................................................................................... 3

5.2 Scope of the post-market surveillance plan ................................................................................................................... 4

5.3 Objective of the post-market surveillance plan .......................................................................................................... 5

5.4 Responsibilities and authorities .............................................................................................................................................. 7

5.5 Data collection ......................................................................................................................................................................................... 7

5.5.1 Data sources ......................................................................................................................................................................... 7

5.5.2 Defining data collection methods ...................................................................................................................... 8

5.5.3 Developing the data collection protocol ...................................................................................................... 9

5.6 Data analysis ............................................................................................................................................................................................. 9

5.6.1 General...................................................................................................................................................................................... 9

5.6.2 Considerations concerning planning the data analysis .................................................................. 9

5.6.3 Methods for data analysis ........................................................................................................................................ 9

5.7 Report on data analysis ................................................................................................................................................................10

5.8 Interface with other processes ...............................................................................................................................................11

6 Review of the post-market surveillance plan ......................................................................................................................12

6.1 Purpose of the review ....................................................................................................................................................................12

6.2 Criteria ........................................................................................................................................................................................................12

6.3 Review .........................................................................................................................................................................................................13

Annex A (informative) Examples of data sources .................................................................................................................................14

Annex B (informative) Examples of data analysis methods ......................................................................................................25

Annex C (informative) Examples of post-market surveillance plans ...............................................................................31

Bibliography .............................................................................................................................................................................................................................43

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This document was prepared by Technical Committee 210, Quality management and corresponding

Any feedback or questions on this document should be directed to the user’s national standards body. A

As medical devices are designed, developed, manufactured and distributed on the global market, a

residual risk with regard to the medical device’s safety and performance remains throughout the

product life cycle. This is due to a combination of factors, such as product variability, factors affecting

the medical device’s use environment, the different end user interaction, as well as unforeseen medical

device failure or misuse. Design and development activities of medical devices ensures that the residual

risk is acceptable before product release (i.e. pre-market). However, it is important to collect and analyse

information on the medical device during production and post-production to meet requirements for

monitoring of product and processes and ensure the residual risk remains acceptable. Appropriate

processes for collecting and analysing the information on the production and post-production feedback

allows for early detection of any undesirable effects. These processes can also reveal opportunities for

improvement, as specified in ISO 13485, or possible relevance to safety, as specified in ISO 14971.

Post-market surveillance is the process to enable manufacturers to perform such monitoring, by

collecting data from actual use of medical devices, analysing these data and then using the information

from post-market surveillance in the appropriate processes, such as product realization, risk

management, communicating to regulatory authorities or product improvement. The extent of a post-

market surveillance process needs to be appropriate and proportionate to the medical device and its use.

The intent of this document is to provide guidance to manufacturers who are planning and executing

their post-market surveillance activities. Other organizations, such as importers, distributors and

reprocessors, that are connected to the manufacturer in the product lifecycle and who play a role in

post-market surveillance activities, can also utilize the guidance in this document for their activities.

In the rest of this document, the term organization will be used instead of manufacturer, as far as

The guidance on the post-market surveillance process described in this document is complimentary

to requirements in ISO 13485 and ISO 14971 for production and post-production activities to conduct

Figure 1 — Inter-relationship of ISO TR 20416 with ISO 13485 and ISO 14971 standards

Decisions and actions, based on the information collected and analysed by application of this document,

are described in other standards, such as ISO 13485 and ISO 14971, and are therefore not included

in this document. The organization may be required to perform post-market surveillance activities

to fulfil applicable regulatory requirements for medical devices. While regulatory requirements

are not described here, this document can be helpful for organizations in fulfilling those regulatory

requirements. This TR uses the definition of post-market surveillance from ISO 13485. Users of this

standard should note that the use of terms with respect to post-production data can vary in different

jurisdictions and define different activities and responsibilities, for example market surveillance.

This document provides guidance on the post-market surveillance process and is intended for use

by medical device manufacturers. This post-market surveillance process is consistent with relevant

international standards, in particular ISO 13485 and ISO 14971. This document describes a proactive

and systematic process that manufacturers can use to collect and analyse appropriate data, to provide

information for the feedback processes and use this to meet applicable regulatory requirements to gain

experience from the post-production activities. The output of this process can be used:

This document does not address market surveillance activities to be performed by regulatory

authorities. Neither does it specify a manufacturer’s actions required by the applicable regulatory

requirements resulting from their production or post-production activities, nor reporting to regulatory

authorities. This document is not intended to replace or change applicable regulatory requirements for

For the purpose of this document, the definitions given in ISO 14971:2019 and ISO 13485:2016 and the

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

study carried out following marketing approval intended to answer specific questions relating to

clinical safety or performance (i.e. residual risks) of a medical device when used in accordance with its

Note 1 to entry: These may examine issues such as long-term performance, the appearance of clinical events

(such as delayed hypersensitivity reactions or thrombosis), events specific to defined patient populations, or the

performance of the medical device in a more representative population of providers and patients.

Note 2 to entry: For in-vitro diagnostics, a similar type of studies exists, e.g. post-market performance follow-up

systematic process to collect and analyse experience gained from medical devices that have been placed

In accordance with the requirements outlined in ISO 13485:2016 Clause 8 and ISO 14971:2019 Clause 10,

the organization documents one or more processes for collecting and analysing data from production

and post-production activities. This information can then be used as input into product realization,

risk management processes, determination of achievement of quality objectives or other actions for

Post-market surveillance can also identify new opportunities for improvement associated with the

medical device in accordance with ISO 13485. It also provides the input to risk management process

in accordance to ISO 14971. Furthermore, it provides input into the design and development change

— Monitoring medical device safety and performance: Post-market surveillance links to other processes

established in the quality management system, including but not limited to feedback, analysis of

data, improvement, design and development processes, including design and development inputs,

risk management, clinical evaluation or performance evaluation. Post-market surveillance activities

help to ensure that available data are analysed and utilized to help make determinations about the

— Meeting regulatory requirements: This document contains suggestions and techniques that can be

used to meet the applicable regulatory requirements. This can include analysing and reviewing

information to gain specific experience from production and post-production activities, trending

of processes and product, as well as feedback to the organisation for improvement activities, as

— Contributing to life cycle management: Post-market surveillance can also identify if the medical

device is not current state of the art based on the information from medical devices used for similar

purposes, the evolution to the state of the art, or alternative medical treatment procedures. These

signals can trigger a design modification, a change in intended use or purpose, a new medical device

design or removal of the medical device from the market. Post-market surveillance can generate

real world information that can be leveraged either to obtain new marketing authorizations for the

medical device (new markets, new indications supported by actual use of the medical device), or of

Figure 2 explains the position of post-market surveillance in the quality management system and its

NOTE Figure 2 is a more detailed representation of phases I and II from Figure 4 provided in the

The post-market surveillance plan defines how the organization intends to actively collect and analyse

relevant data from the use of the medical device throughout the life cycle. Figure 2 outlines how the

post-market surveillance process interacts with other processes in a quality management system.

NOTE If a quality management system is not established, the same principles apply, although the processes

The organization should ensure post-market surveillance activities are carried out in line with

documented methods and that the results of such activities are evaluated and reported to top

The post-market surveillance activities should be planned before the first placing on the market of the

medical device and updated as necessary during product life cycle (see Clause 6).

The extent of post-market surveillance activities will depend upon several factors, such as the risks

associated with the medical device, the chosen data sources or the expected robustness of the available

The post-market surveillance plan provides details on how the following clauses of this document

are addressed for the medical device or medical device family subject to the plan. The post-market

surveillance plan also addresses the methods used to collect and analyse available data in order to

The plan, as well as any data, information and reports generated according to the plan are considered

An approved post-market surveillance plan should be contained within one or more documents

within the quality management system and may include references to other documents or procedures

Post-market surveillance plans should consider input from a cross-functional team, see 5.4.

The scope of the post-market surveillance plan depends on the type of the medical device. The following

— expected lifetime of the medical device, expected number of uses or usage frequency of the medical

— the available data related to safety and performance of the medical device, including clinical data;

— life cycle stage with regard to product and technology maturity in relation to state of the art.

By considering these examples and appropriately scoping the plan, the amount of resulting information

Regardless of the extent of design and development verification and validation activities, there will

always be some uncertainty about the safety and performance of the medical device during its life

cycle. The objectives of the post-market surveillance plan include reducing the identified uncertainty

The post-market surveillance plan sets the objectives for the post-market surveillance activities in

relation with the medical device life cycle, the specification of the medical device, the intended use or

application and the applicable regulatory requirements in different markets. The plan should identify

the type and adequacy of information to be collected in order to satisfy the objectives. They can address

various aspects of the medical device, such as safety and performance including usability, labelling,

On defining the objectives of the post-market surveillance plan, the organization should specify the

associated measurable criteria, alert and action levels, as appropriate (see also 5.6).

— Has any new hazard or hazardous situation been identified for the medical device or similar medical

— Does the medical device meet the user’s needs after medium/long term clinical use?

— Are there any unforeseen side effects for the medical device or similar medical devices?

— Has state of the art changed after design and development of the medical device?

— Does the patient’s average age at medical device implantation, affect the medical device lifetime?

— Are indications or contra-indications appropriate to ensure safety and effectiveness for the intended

— Can significant increasing/decreasing trends be identified for a specific medical device malfunction

Table 1 and the example plans in Annex C provide more specific examples of objectives. The examples

given in Table 1 illustrate how some situations can lead to different objectives of a post-market

Design and development A new medical device that has just Monitor the safety and performance

Risk management Commercial launch of a surgical Continue to monitor the safety, per-

Clinical evaluation/ perfor- An implantable medical device for Obtain information on the long-term

mance evaluation which a clinical investigation was safety and performance of the medi-

Regulatory Information from a user suggests that Invoke company feedback procedures

Improvement Medical device already on the market Monitor continued satisfaction of the

Marketing and sales An organization intends to market an Ensure appropriate usability data are

Annex C contains several detailed examples of post-market surveillance activities for different types of

Top management should define, assign and communicate responsibilities and authorities for post-

market surveillance activities and should ensure the availability of resources with the independence

and competence for post-market surveillance activities. The post-market surveillance team should

include cross-functional representatives, for example resources from design and development, risk

management, quality assurance, complaint handling, returned medical device analysis, product