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9 NOTABLE CHANGES WITH

ISO 14971:2019
THE MEDICAL DEVICE
RISK MANAGEMENT STANDARD
By Michael B. Checketts

The turn of the decade isn’t going unnoticed when it
comes to medical device standards. The long awaited
Risk Management standard (ISO 14971, 3rd Ed.) was
released for publication in late 2019. In addition, there
is a new companion guidance document released,
known as ISO/TR 24971:2019. Technical Reports (TR)
are one of the types of documents that ISO publishes.
A TR requires less international consensus than their
Standards. Also, it is close enough numerically to be
remembered as a companion, and not disassociated
with ISO14971:2019.
At first glance it seems a loss that the well-used &
familiar references (Annexes C, and F – J, see below)
were stripped from ISO 14971, and another standard
will need to be purchased in order to retain current
references. However, by drilling past the surface
information of this updated standard, a very logical
gold mine of information is provided for us, that hasn’t
been previously available.

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Annex C: Questions that can be used to ID medical device characteristics that could impact on safety

Annex F: Risk management plan

Annex G: Information on risk management techniques

Annex H: Guidance on risk management for in vitro diagnostic medical devices

Annex I: Guidance on risk analysis process for biological hazards

Annex J: Information for safety and information about residual risk

SO, LET’S REVIEW THE MAJOR CHANGES IN THIS NEW VERSION OF RISK
MANAGEMENT FOR MEDICAL DEVICE MANUFACTURING.

The “high level clause structure” of this standard now conforms to the ISO-mandated
1 ten clauses. All new or revised management system Standards published by ISO going
forward must use the same ten high level clause names, numbers and use specified
definitions and some common text. Those familiar with international standard formats
(within ISO/ANSI/AAMI), will have familiar ground when perusing
through ISO 14971:2019.

2 There is further alignment with changes being made to other national standards, such
as ISO/IEC directives in general and specifically Guide 63:2019 & 51:2014, ISO 18113-
1:2009, ISO 9000:2015, ISO 13485:2016, ISO 31000:2018, ISO 10993-1, IEC 60601-1,
IEC 62366-1:2015 and ISO 24971:2019. There are of course more, but these are of
particular interest.

3 Management Responsibilities for device makers have expanded in ISO14971:2019 to

include approaches for risk control wherein reducing risk as low as reasonably achievable
is now a direct responsibility. Reviewing production and postproduction information as
an input to the risk management process (clause 4.2) is now a requirement. Multiple
clarifications are also made in clause 9, to help in the Risk Management Review prior to
commercial release of product.

4 “Intended use of the medical device and reasonably foreseeable misuse” is now the
title of clause 5.2. There is no mistaking the manufacturer’s responsibilities in this
area, as it is now mentioned throughout the document especially when residual risk is
discussed (clauses 7.3 & 8).

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 5 Another area of clarification involves safety, and hazards & hazardous situations. The
sub-clauses of Clause 5 (Risk Analysis), now have separate sub-clauses related to
safety (5.3), and another for ID of hazards and hazardous situations (5.4). No longer
should these concepts be misconstrued.

6 Risk evaluation (clause 6) no longer asks the manufacturer to determine whether

risk reduction is required (the likelihood of a “NO” answer is pretty high). Instead, a
concerted effort must be made to evaluate the acceptability of the risk as defined in the
risk management plan, and put risk control measures into place appropriately. Specific
paragraphs deal with how to handle both “acceptable risk” and “unacceptable risk”
situations.

7 Within the purview of Risk Control (clause 7), “Risk reduction” is no longer a sub-clause.
Instead, “Risk control option analysis”, and “Implementation of risk control measures”
are used. The emphasis is now that some measure of control is required in all situations.
This is expounded upon, but is thematic throughout the clause.

8 Clause 8 is still concerned with residual risk, but has been rewritten based upon the
assumption that there will always be residual risk. However, if adequately controlled,
that risk may be acceptable based upon the method and criteria for acceptability
defined in the risk management plan. If it is found to be acceptable, the residual risk
shall be disclosed to the user through the device’s accompanying documentation (e.g.
IFU’s). If the residual risk is not found acceptable, either the device design, its intended
use or both must change.

9 The topic of Production and post-production information (clause 10) has been
completely rewritten, to expand on the responsibility of the manufacturer to actively
collect and review data relevant to all phases of the life cycle of the medical device.
Actions (10.4) must be taken based upon the feedback and whether residual risk has
changed. The degree to which change occurs will determine the actions taken. All of
this must be documented in the risk management file, and in other
appropriate documents.

A chart has been created within Annex B of ISO
14971, which delineates all the differences/changes
in this standard from the 2nd edition (2007) to the 3rd
edition (2019). A portion of that has been recreated
here within Table 1. However, only the Annexes are
shown, since the content of the actual standard has
been discussed throughout this article.
Each clause, sub-clause and note of ISO 14971:2019
have further background and guidance information
within the new ISO/TR 24971:2019. The clauses of
this TR document are the same as ISO14971:2019.
I have taken the liberty to include a listing of the
Annexes for ISO/TR 24971:2019 below:

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Annex A: ID of hazards and characteristics related to safety

Annex B: Techniques that support risk analysis

Annex C: Relation between & policy, criteria for risk acceptability risk control & risk evaluation

Annex D: Information for safety and information on residual risk

Annex E: Role of international standards in risk management

Annex F: Guidance on risks related to security

Annex G: Components and devices designed without using ISO 14971

Annex H: Guidance for in vitro diagnostic medical devices

There will be a webinar held on 05 Mar 2020, in which I will discuss these changes/updates in more detail.
It is likely there will be enough time for a Q & A wherein some of these items may be discussed in even
further detail. To join the webinar click here for further details and free webinar registration

TABLE 1
ISO 14971:2007 ISO 14971:2019

Annex A Rationale for requirements Annex A Same title, but updated for Ed 3

Similar title, but also contains a table

Overview of the risk management
Annex B Annex B comparing the 2007 version to the
process for medical devices
2019 version.
Questions that can be used to ID
Annex C medical device characteristics that Moved to ISO/TR 24971, Annex A
could impact on safety
Risk concepts applied to
Annex D
medical devices
Fundamental risk concepts, and;
Examples of hazards, foreseeable Annex C
Moved to ISO/TR 24971 Annex C
Annex E sequences of events and hazardous
situations

Annex F Risk management plan Moved to ISO/TR 4.4.8-4.4.1( 4.4 :24971)

Information on risk management

Annex G Moved to ISO/TR 24971, Annex B
techniques
Guidance on risk management for in
Annex H Moved to ISO/TR 24971, Annex H
vitro diagnostic medical devices
Guidance on risk analysis process for Relationship to Directive 42/93/EEC
Annex I Annex ZA
biological hazards [OJ L 169]
Information for safety and information Relationship to Directive 385/90/EEC
Annex J Annex ZB
about residual risk [OJ L 189]
Relationship to Directive 79/98/EC [OJ
Annex ZC
L 331]
Relationship to Regulation (EU)
Annex ZD
745/2017
Relationship to Regulation (EU)
Annex ZE
746/2017
MICHAEL CHECKETTS
Michael Checketts is a Senior Manager with extensive
Engineering, Quality and Regulatory management
experience. Whether it may be in Product Development,
Manufacturing, or Quality Management Systems, his
greatest desires are to improve manufacturability &
time to market. He also well understands the need
for reducing costs while continually improving quality
& compliance/conformance. Michael is a certified
Lead Auditor for ISO 13485:2016, ISO 14001:2015, ISO
17025:2017, and ISO 9001:2015.

Mr. Checketts has extensive experience in the Medical

Device industry, and served as a Manufacturing Engineer
& Engineering Manager for Abbott Laboratories, where
many products were successfully moved from R&D to
manufacturing. Improvements in manufacturability
became his forte. Michael transitioned into the Medical
Device startup company environment and utilized these
same techniques to provide superior manufacturability.
Utilizing tools such as SPC, and verification/validation
techniques (IQ/OQ/PQ, incorporating DOE and Process
Capability) was key to his success. These companies
were subsequently acquired by major medical device
companies (EP Technologies by Boston Scientific and
VidaMed by Medtronic). All facets of engineering have
been managed by Michael. Those disciplines include
R&D, Design/Drafting, Product Development, Industrial/
Manufacturing Engineering, Machine/Tool Design,
Rapid Prototyping, Tool & Mold Shops,
and Facilities.
In addition to his engineering expertise, Michael has
extensive Quality/Regulatory experience in the Medical
Device industry, with an OEM (VidaMed Inc.), and a Tier
1 supplier (TSE/AMETEK). As a Quality/Regulatory
manager he has initiated/updated 510(k)’s/PMA’s/
IDE’s, and generated/maintained Quality Management
Systems. Process validations have successfully been
completed by Michael in the areas of Cleanroom
Processing, Terminally Sterile Packaging, EO
Sterilization and Gamma Sterilization. Conformance
to ISO 9001 & 13485 standards have been initiated
and successfully certified. Multiple facilities with
their own QMS, have been harmonized under a single
“Global” corporate QMS, and successfully found
conforming. Each company has been compliant to
21CFR Parts 11 & 820.
Within multiple companies Michael has been
designated the “Management Representative”,
wherein he has interfaced directly with Registrars
and Regulatory Agencies. In all cases, registration
conformance and statutory compliance was
maintained and never lost. In many cases “potential
noncompliances” were re-designated as compliances
before the end of the audit by providing appropriate
documentation or successfully negotiating the correct
perspective of the standard or regulation. Whenever
a non-compliance or citation (483) was received,
each was mitigated and Verification of Effectiveness
accepted within the agreed upon timing. The
following QA/RA disciplines have been successfully
managed by Michael: Quality Engineering, Document
Control, Inspection, Maintenance/Calibration, Internal
Auditing, Supplier Quality, and Regulatory Affairs.
EDUCATION
Bachelor of Science, Manufacturing Engineering,
with a minor in Chemistry from Weber State
University, Ogden, UT.

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315 E. Eisenhower Parkway, Suite 214, Ann Arbor, MI 48108
Phone: (734) 761-4940 | Fax: (734) 761-4966 | Email: info@omnex.com | Web: www.omnex.com