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Copyright © 2014 BSI. All rights reserved. 1
BSI 2014 Medical Device Mini-Roadshow
Risk Management and the Impact of EN ISO 14971:2012 Annex Z
Ibim Tariah Ph.D Technical Director, Healthcare Solutions
Copyright © 2014 BSI. All rights reserved. 2
• Overview of ISO 14971:2007 • EN ISO 14971:2012
• Harmonized Standard – Differences from ISO Standard and 2009 version
• Deviations – Presumption of Conformity
• BSI Audits • FAQs Regarding EN ISO 14971:2012*
Risk Management - Impact of Annex Z
* Included in presentation materials but not discussed
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ISO 14971:2007 – Medical Devices – Application of Risk Management to Medical Devices
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Definitions
Risk = Combination of the probability of occurrence of harm and the severity of that harm
Harm = Physical injury or damage to the health of people, or damage to property, or the environment
Severity Low High No harmDeath / Serious Injury
Occurrence Improbable Frequent < X% Y – Z% (Sometimes factor of occurrence of hazard x % of harm / hazard)
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1 Scope 2 Terms and definitions 3 General requirements for risk management
3.1 Risk management process 3.2 Management responsibilities 3.3 Qualification of personnel 3.4 Risk management plan 3.5 Risk management file
ISO 14971 – Main body (Clauses 1-3)
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Clause 4: Risk analysis
Clause 5: Risk evaluation
Clause 6: Risk control
Clause 7: Residual risk evaluation
Clause 8: Risk management report
Clause 9: Post-production information
ISO 14971 – Main body (Clauses 4-9)
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Annex A (informative) Rationale for requirements Annex B (informative) Overview of the risk management process for
medical devices Annex C (informative) Questions that can be used to identify medical
device characteristics that could impact on safety Annex D (informative) Risk concepts applied to medical devices Annex E (informative) Examples of hazards, foreseeable sequences of
events and hazardous situations
ISO 14971 – Overview of Annexes
probability
risk control
qualitative analysis benefit estimation
“ALARP”
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Annex F (informative) Risk management plan Annex G (informative) Information on risk management techniques Annex H (informative) Guidance on risk management for in vitro
diagnostic (IVD) medical devices Annex I (informative) Guidance on risk analysis process for biological
hazards Annex J (informative) Information for safety and information about
residual risk
ISO 14971 – Overview of Annexes
FMEA HAZOP
FTA PHA
HACCP
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Risk Management – EU Requirements • MDD • AIMDD • IVDD
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Medical Devices – EU Risk Requirements
Benefits
Risks
Benefits > Risks
Risks > Benefits
R R B
B
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The Directives – Where is ‘Risk’?
MDD 93/42/EEC
AIMDD 90/385/EEC
IVDD 98/79/EC
“Risk” ERs: 1 2 6 7.2, 7.4, 7.5, 7.6 8.1, 8.6 9.2, 9.3 11.2, 11.4 12.1, 12.5, 12.6,
12.7 13.5, 13.6
ERs: 1 5 8 9 10 11 15
ERs: A – 1 2 B – 1.2 2.1, 2.2, 2.5, 2.7 3.2, 3.3, 3.4 5.3 6.2, 6.3, 6.4 7.1 8.6, 8.7
Total 41 18 24
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EN ISO 14971:2012
• EU harmonized standard for Risk Management • Allows the presumption of conformity to MDD, AIMD, and IVD
• Published July 2012 & harmonized as of 30 August 2012.
http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/medical-devices/index_en.htm
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What is the difference?
ISO
149
71:2
007 • The current
International Standard
EN I
SO 1
4971
:200
9 • The previous version of the European Harmonized Standard
• Obsolete as of
30 August 2012
EN I
SO 1
4971
:201
2 • The current European Harmonized Standard
• Changes within Foreword & Annex Zs only
• No change to requirements (Normative Text)
• i.e. clauses or requirements of the standard are exactly the same
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Why was EN ISO 14971:2012 created? • A solution to formal objections raised by Swedish
Competent Authority & European Commission on the harmonized status of a number of European Standards
• Revision of Annex Z’s was made to provide greater clarity on applicability & alignment of ISO 14971 clauses with requirements of AIMDD, MDD & IVDD
Copyright © 2014 BSI. All rights reserved. 15 Copyright © 2014 BSI. All rights reserved.
EN ISO 14971:2012 – Z Annexes
•“Explains to which requirements, under which conditions and to what extent presumption of conformity can be claimed.”
Example – Annex ZA (MDD)
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(Now Obsolete) • Compliance with all the requirement clauses in
this standard will ensure that general aspects of medical devices related to patient risk and safety have been addressed.
• For particular medical devices or for particular safety aspects, additional specific requirements may need to be complied with in order to meet the essential requirements.
EN ISO 14971:2009 – Z Annexes
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EN ISO 14971:2012 – Content Deviations
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EN ISO 14971:2012 – Content Deviations Essential Requirements (ERs)
Impacted
Deviation MDD AIMDD IVDD
1 – Treatment of negligible risks 1, 2, 6, 7.1 1, 5, 9 A.1, A.2, B.1.1
2 – Discretionary power of mfr as to acceptability of risks
1, 2, 6, 7.1 1, 5, 9
A.1, A.2, B.1.1
3 – Risk reduction “as far as possible” vs. “as low as reasonably practicable”
1, 2, 6, 7.1 1, 5, 6, 9
A.1, A.2, B.1.1
4 – Discretion as to whether a risk- benefit analysis needs to take place
1, 6, 7.1 5 & 9
A.1 & B.1.1
5 – Discretion as to the risk control options / measures
2 & 7.1 - A.2 & B.1.1
6 – Deviation as to the first risk control option
2 & 7.1 - A.2 & B.1.1
7 – Information of the users influencing the residual risk
2 & 7.1 - A.2 & B.1.1
Copyright © 2014 BSI. All rights reserved. 19
‘...all risks, regardless of their dimension, need to be reduced as much as possible (and need to be balanced,
together with all other risks, against the benefit of the
device).’
‘D.8.2 ...the manufacturer may discard
negligible risks.’
Deviation No. 1
ISO 14971
MDD (AIMDD) IVDD
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Failure Mode
Cause of Failure
Local Effect
System Effect
Initial Rating
Risk Control Measure(s)
Risk Level
SEV
PRO
RPN
Hip Stem
Surgeon implants a stem that is wrongly sized
No tool available to determine needed size
Unstable Implant
Revision 8 1 8 X-ray templates provided for each implant size; implants marked with size; clinical history of safety / performance
Acceptable & reduced as far as possible
Were all risks considered for mitigation?
It is not sufficient just to determine that the risks are acceptable. It is also necessary to determine whether they have been reduced as far as possible. This can
be stated line-by-line or categorically as a whole.
Broadly Acceptable
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Deviation No. 2
‘....all risks have to be reduced as far as possible (and that all risks combined, regardless of
any "acceptability" assessment, need to be balanced, together with all other risks, against the
benefit of the device).’
‘5, 6.4, 6.5 & 7 ...manufacturers have the freedom to decide
upon the threshold for risk acceptability.’
‘D.6.1 …only non-acceptable risks have to be integrated into
the overall risk-benefit analysis.’
ISO 14971
MDD (AIMDD) IVDD
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Are all risks reduced as far as possible? Extent of damage
10
Pro
babi
lity
of o
ccu
rren
ce
9
8
7
6
5
4
3
2
1
1 2 3 4 5 6 7 8 9 10
Some risks cannot be categorically ignored if
risk can be reduced further. All risks must be
reduced as far as possible.
Broadly Acceptable
Management Review Required - ALARP
Unacceptable
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Deviation No. 3
ISO 14971
MDD AIMD IVD
‘....risks to be reduced "as far as possible" without there being room for
economic considerations.’
‘3.4 & D.8 …contains the concept of reducing
risks "as low as reasonably practicable.”
The ALARP concept contains an element of
economic consideration.’
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Are all risks reduced as far as possible? Extent of damage
10
Pro
babi
lity
of o
ccu
rren
ce
9
8
7
6
5
4
3
2
1
1 2 3 4 5 6 7 8 9 10
There must be another step – ALARP concept
should not allow economic factors to
hinder mitigation, risks must be reduced as far as possible within state-
of-the-art
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Failure Mode
Cause of Failure
Local Effect
System Effect
Initial Rating
Risk Control Measure(s)
Risk Level
SEV
PRO
RPN
Hip Stem
Surgeon implants a stem that is wrongly sized
No tool available to determine needed size
Unstable Implant
Revision 8 5 40 X-ray templates provided for every-other implant size; implants marked with size
ALARP
Were risks reduced as far as possible?
It is not reasonable in this example not to provide templates for each size. The economic impact of this should not be considered if this can reduce the risk. To make this determination, the state-of-the-art and
available technology should be considered.
Copyright © 2014 BSI. All rights reserved. 26
Deviation No. 4
ISO 14971
MDD AIMDD (IVDD)
‘....an overall risk-benefit analysis must take place in any case, regardless of the criteria
established in the mgmt plan of the mfr . . . (and requires undesirable side effects to
"constitute an acceptable risk when weighed against the performance intended“).’
‘6.5 ...an overall risk-benefit analysis does
not need to take place if the overall residual risk is judged acceptable
when using the criteria established in the risk
mgmt plan. D.6.1 "A risk/benefit
analysis is not required by this Int’l Std for
every risk.“’
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The Directives – Where is ‘Benefit’?
MDD 93/42/EEC
AIMDD 90/385/EEC
IVDD 98/79/EC
“Benefit” ERs: 1 7.4 11.2
ERs: 10
ERs: A – 1
Total 3 1 1
“Risk” 41 18 24
MEDDEV 2.7.1 – Guidelines on Clinical Evaluation Report also discusses Risk / Benefit Analysis
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Conduct Risk v Benefit
Risk / benefit analysis done for all risks?
Occasional
Frequent
Improbable
Probable
Remote
Acceptable
Consider Risk v Benefit 4
3
6
3
2
2
There must be a risk benefit analysis for all
risks and an overall risk benefit analysis – not just unacceptable risks
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Documentation of Risk / Benefit Analysis
• Risk Management File o Combination of risk assessment / risk management report
• Clinical Evaluation Report (Frequently addressed here)
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‘....”to select the most appropriate solutions”.....by applying
cumulatively what has been called "control options” or "control
mechanisms" in the standard.’
‘6.2 ...obliges the mfr to "use one or more of the following risk control options in the priority order
listed.’ ‘6.4 …indicates that further risk control measures do not
need to be taken if, after applying one of the options, the risk is judged acceptable according to the criteria of
the risk mgmt plan.’
Deviation No. 5
ISO 14971
MDD IVDD
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Failure Mode
Cause of Failure
Local Effect
System Effect
Initial Rating Risk Control Measure(s)
Risk Level
SEV
PRO
RPN
Intra-cranial Pressure Monitor
High pressure undetected
Monitor does not indicate high pressure situation
Brain damage
Death 10 4 40 Monitor provides continuous digital display of ICP; operates on AC & for up to 3 hrs on battery
ALARP
All appropriate controls utilized?
No control measures mentioned about alarms / warnings for high pressure situation. The current
mitigation is not considered to be sufficient as preventive measures could mitigate the risk.
Copyright © 2014 BSI. All rights reserved. 32
Deviation No. 6
ISO 14971
MDD (IVDD)
‘..."eliminate or reduce risks
as far as possible (inherently safe design and
construction)".’
‘6.2.... obliges the manufacturer to "use one or more of the
following risk control options in the priority
order listed: (a) inherent safety by
design . . .” without determining what is meant by this
term.’
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Failure Mode
Cause of Failure
Local Effect
System Effect
Initial Rating
Risk Control
Measure(s)
Risk Level
SEV
PRO
RPN
Mesh Mesh frays and suture pulls out
Design of mesh / cutting edge
Failed repair
Revision 7 5 35
Acceptable & reduced as far as possible
Warp knit mesh design prevents fraying after cut; multiple sizes available; suture pullout testing
Were risks designed out if possible?
Risks must be designed out if possible. All risk control options must be applied until risks have been reduced
as much as possible and any additional control option(s) do not improve the safety
IFU instructs not to cut mesh and not to place sutures closer than 5 mm to edge
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‘....users shall be informed about the residual risks. This indicates that....the information given to the users does not reduce the
(residual) risk any further.’
‘2.15 & 6.4 …residual risk is defined as the risk remaining after application of risk control measures.’
‘6.2 …regards "information for safety" to be a control option.’
Deviation No. 7
ISO 14971
MDD (IVDD)
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Residual risks incorrectly reduced?
Device Failure Mode
Effect Initial Rating
Risk Control
Updated Rating
SEV
PRO
RPN
SEV
PRO
RPN
Implant Emboli Death 4 3 12 IFU warning
4 1 4
A warning does not reduce the probability of occurrence of an
emboli.
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Residual risks incorrectly reduced? Device Failure
Mode Effect Initial
Rating Risk Control Updated
Rating
SEV
PRO
RPN
SEV
PRO
RPN
Mesh with Barrier Membrane
Device implanted upside-down
Adhesions 4 3 12 IFU contains pictures / instructions on how to correctly orient device with marked side down
4 1 4
Instructions on how to use the device properly may mitigate the risk
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BSI Audits
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Conformity Assessment
Quality System n=70 Americas
n=50 EMEA n=40 Asia-
Pacific
Microbiologist n=20
Technical Specialist
n=80
External Resource
n=as needed
Copyright © 2014 BSI. All rights reserved. 39
• Are you aware of EN ISO
14971:2012? • How are you ensuring you meet
the directive requirements?
• Have you reviewed your existing Risk Management files, if needed? • Is there a plan in place to do so?
BSI Audit – Key Questions
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• Have all risks been reduced as far
as possible?
• Has a risk benefit analysis been conducted for all risks?
• Have all risks been designed out if possible?
• Have risks been incorrectly reduced by warnings placed on IFUs or provided in training?
BSI Audit – Key Questions
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Questions
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FAQs Regarding EN ISO 14971:2012
1. If our procedures were written to comply with ISO 14971:2007, do we have to change them? The normative part of the standard is identical. Most likely. The Z Annexes (ZA, ZB, and ZC) discuss deviations from the standard relative to the ability to comply with the MDD, AIMD, and IVDD. Therefore, additional steps must usually be taken in order to demonstrate compliance with the Essential Requirements (ERs) within the directives. In many cases, changes will need to be made to address the following (at a minimum): ensuring that • ALL risks are reduced as far as possible; • a risk/benefit analysis was conducted and considers all individual and overall risks; • ALL risks have appropriate controls and the risks have been designed out if
possible (MDD & IVDD only); • risks have not been inappropriately reduced by labeling alone (MDD & IVDD only).
Copyright © 2014 BSI. All rights reserved. 44
FAQs Regarding EN ISO 14971:2012 2. Isn’t the point of risk management to focus on the
big risks? It is true that risk management activities have historically focused on identifying and reducing risks that have been unacceptable or were significant. However, the directives do not make distinctions in risk levels and simply refer to reducing ALL risks. Therefore, based on current thinking, in order to comply with the directives, the focus should be on reducing ALL risks.
3. As a manufacturer, how can we not take into account any economic considerations? It is understood that all risks cannot be eliminated and that the manufacturer is bound by the level of current technology and the state-of-the-art. It is also understood that a single device may not be intended for all individuals / applications and could be limited to certain populations. Therefore, the expectation is that if there are means to reduce risks for the intended use by available technologies and the state-of-the-art, that these measures should be taken. As risk management is also an active process that should continue to be evaluated post-production, if new technologies or the state-of-the-art change after the device was released, the question as to whether ALL risks have been reduced as far as possible should continue to be evaluated.
Copyright © 2014 BSI. All rights reserved. 45
FAQs Regarding EN ISO 14971:2012 4. Our QMS auditor said our RM procedures were
effective and met EN ISO 14971:2012. We don’t understand why the Technical Reviewer gave us a non-conformity for risk management.
The primary responsibility for the QMS auditor is to review the manufacturer’s procedures to ensure that they meet ISO 13485 and to sample records to ensure that the procedures have been executed appropriately. On the other hand, the primary responsibility for the Technical Reviewer is to review the output of the QMS system (i.e. Technical Documentation) and ensure that the product conforms to the applicable directive. Therefore, it is possible for the procedures and some of the records to have been updated to ensure compliance with EN ISO 14971:2012 but that the file(s) being reviewed by the Technical Reviewer do not demonstrate compliance with the directive.
Copyright © 2014 BSI. All rights reserved. 46
FAQs Regarding EN ISO 14971:2012
5. Do we have to change all our historical RM files or can we just address new product development and product changes?
All files should be reviewed (based on a risk commensurate plan) to ensure that they comply with the directives and updated accordingly. Demonstration of compliance is expected.
6. Does BSI expect a line-by-line risk/benefit analysis? No. The manufacturer is expected to consider all individual risks and the overall risk in a risk / benefit analysis. How that is done is up to the manufacturer. BSI expects that the manufacturer documents (procedurally) how they intend to do this and executes this procedure.
Copyright © 2014 BSI. All rights reserved. 47
FAQs Regarding EN ISO 14971:2012
7. We have used a “no-train, no-sale” policy to reduce the risk of issues. Could this be used to reduce the probability of occurrence? Potentially. Deviation 7 only addresses not using information given to the users (i.e. in the IFU or through training) to reduce risks further. Therefore, if the training program is being used to teach the user proper operation of the device, this would most likely not be considered providing information to address residual risk. However, if this is being used as a forum to convey residual risk about the device, this would not be considered an appropriate way to mitigate risk.
Copyright © 2014 BSI. All rights reserved. 48
FAQs Regarding EN ISO 14971:2012 8. BSI agreed at the last design exam certification
review that the RM files were acceptable and met the ERs. The device has not changed. Why is this not still acceptable?
Harmonized standards are used as a method to convey state-of-the-art thinking on how compliance with the clauses of the standard confer a presumption of conformity with the associated directive and EFTA regulations. The Z Annexes explain to which requirements, under which conditions, and to what extent presumption of conformity can be claimed. Publishing of EN ISO 14971:2012 changed the state-of-the art view of these conditions. Therefore, while previous submissions may have allowed full presumption of conformity with the directives, this is no longer possible unless additional information is provided to address the deviations.
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