risk management and the impact of en iso 14971:2012 · pdf fileiso 14971:2007 is the current...

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


• 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

Presenter

Presentation Notes

Hope you will find this valuable and address some of your questions.


ISO 14971:2007 – Medical Devices – Application of Risk Management to Medical Devices

Presenter

Presentation Notes

ISO 14971:2007 is the current version of the international standard for the Application of Risk Management to Medical Devices.


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)

Presenter

Presentation Notes

In the standard, Risk and Harm are defined as shown here. Severity and Occurrence can be defined qualitatively or quantitatively. Often see only the occurrence of the hazard with no characterization of harm (except perhaps through the definition of the severity ratings) Also often see same hazard with different harms (i.e. hazard may cause death in few cases but may also cause injury in many cases). In this case, it is important to determine the risk for each scenario. Different controls may be warranted for each situation.

Copyright © 2014 BSI. All rights reserved. 5 Copyright © 2014 BSI. All rights reserved.

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)

Presenter

Presentation Notes

As a reminder, the normative part of the standard (the main body) consists of 9 sections. The first 3 clauses discuss the scope, definitions, and general requirements for risk management.


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)

Presenter

Presentation Notes

Whereas clause 4 – 9 go into the detail of how to actually do risk management.


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”

Presenter

Presentation Notes

Following that, there are 10 annexes which are all informative that provide background and examples of how different portions of the process could be done.

http://www.sodahead.com/entertainment/katie-couric-to-interview-manti-teo-biggest-televised-celeb-interview-ever/question-3471087/


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


Risk Management – EU Requirements • MDD • AIMDD • IVDD


Medical Devices – EU Risk Requirements

Benefits

Risks

Benefits > Risks

Risks > Benefits

R R B

B

Presenter

Presentation Notes

Bottom line . . . benefit must outweigh the risk!


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


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

Presenter

Presentation Notes

Key Point – No transition period for implementation. As of July 2012, EN ISO 14971:2009 ceases to give presumption of conformity with the ERs.


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


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


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)

Presenter

Presentation Notes

Basically this is saying that clauses 1 -9 of the standard represent a tool that can be used to generate the information to demonstrate conformity to ER 1. However, the standard does not directly cover ER 1. Then it identifies where there are deviations to specific points. There is a Z Annex for each of the directives for medical devices.


(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

Presenter

Presentation Notes

Compare this to the Z Annexes from the 2009 version. In the past, it was generally regarded that if compliance was demonstrated with EN ISO 14971:2009, then it was presumed that conformity with ERs associated with risk was demonstrated. This is no longer the case.


EN ISO 14971:2012 – Content Deviations


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

Presenter

Presentation Notes

There are 7 deviations for MDD and IVDD and 4 for AIMDD that impact a handful of ERs. For the most part, they are common for the different directives. I am going to walk through each one of these and give a quick example to demonstrate the deviation. MDD 1. The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety. This shall include: — reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and — consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users). 2. The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknowledged state of the art. In selecting the most appropriate solutions, the manufacturer must apply the following principles in the following order: — eliminate or reduce risks as far as possible (inherently safe design and construction), — where appropriate take adequate protection measures including alarms if necessary, in relation to risks that cannot be eliminated, — inform users of the residual risks due to any shortcomings of the protection measures adopted. 6. Any undesirable side-effect must constitute an acceptable risk when weighed against the performances intended. 7.1. The devices must be designed and manufactured in such a way as to guarantee the characteristics and performances referred to in Section I on the ‘General requirements’. Particular attention must be paid to: — the choice of materials used, particularly as regards toxicity and, where appropriate, flammability, — the compatibility between the materials used and biological tissues, cells and body fluids, taking account of the intended purpose of the device, — where appropriate, the results of biophysical or modelling research whose validity has been demonstrated beforehand. AIMD 1. The devices must be designed and manufactured in such a way that, when implanted under the conditions and for the purposes laid down, their use does not compromise the clinical condition or the safety of patients. They must not present any risk to the persons implanting them or, where applicable, to other persons. 5. Any side effects or undesirable conditions must constitute acceptable risks when weighed against the performances intended. 9. The devices must be designed and manufactured in such a way as to guarantee the characteristics and performances referred to in I. ‘General requirements’, with particular attention being paid to: — the choice of materials used, particularly as regards toxicity aspects, — mutual compatibility between the materials used and biological tissues, cells and body fluids, account being taken of the anticipated use of the device, — compatibility of the devices with the substances they are intended to administer, — the quality of the connections, particularly in respect of safety, — the reliability of the source of energy, — if appropriate, that they are leakproof, — proper functioning of the programming and control systems, including software. For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification. IVDD A1. The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise, directly or indirectly, the clinical condition or the safety of the patients, the safety or health of users or, where applicable, other persons, or the safety of property. Any risks which may be associated with their use must be acceptable when weighed against the benefits to the patient and be compatible with a high level of protection of health and safety. A2. The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknowledged state of the art. In selecting the most appropriate solutions, the manufacturer must apply the following principles in the following order: - eliminate or reduce risks as far as possible (inherently safe design and construction), - where appropriate take adequate protection measures in relation to risks that cannot be eliminated, inform users of the residual risks due to any shortcomings of the protection measures adopted. B1.1. The devices must be designed and manufactured in such a way as to achieve the characteristics and performances referred to in section A on the 'General requirements`. Particular attention must be paid to the possibility of impairment of analytical performance due to incompatibility between the materials used and the specimens (such as biological tissues, cells, body fluids and micro-organisms) intended to be used with the device, taking account of its intended purpose.


‘...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

Presenter

Presentation Notes

AIMD deviation does not contain the parenthetical language.


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

Presenter

Presentation Notes

Here is a simple example of an aFMEA for a hip stem. You can see the failure mode, cause of the failure, the local and system effects with a risk rating and identification of control measures. Under ISO 14971:2007, it would be quite acceptable to identify this risk as broadly acceptable and not have to mitigate the risk any further because the risk is considered to be very low / negligible. Under EN ISO 14971:2012, this is not sufficient. It is also necessary to mitigate all risks if possible.


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

Presenter

Presentation Notes

AIMD deviation does not contain the parenthetical language. Deviation 2 is similar.


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


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.’


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

Presenter

Presentation Notes

In this example, the risks levels have been subdivided into 3 groups where the yellow group is defined as ALARP (as low as reasonable practicable). However, the directives use the words “reduced as far as possible” so economic factors should not hinder the further mitigation of risks if there are controls available within the state-of-the-art.


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.

Presenter

Presentation Notes

To demonstrate this deviation, I have gone back to the aFMEA scenario I discussed previously. In this case, however, I have modified the risk control measure because I was trying to save money.


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.“’

Presenter

Presentation Notes

IVDD deviation does not contain the parenthetical language.


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


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


Documentation of Risk / Benefit Analysis

• Risk Management File o Combination of risk assessment / risk management report

• Clinical Evaluation Report (Frequently addressed here)


‘....”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

Presenter

Presentation Notes

The rest of the deviations only apply to MDD and IVDD Priority Order: Inherent Safety by design Preventative Measures Information for Safety


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.

Presenter

Presentation Notes

There are many that argue that alarms by themselves do not actually mitigate risk if no one acts on them. However, in this example, this device is utilized in a highly monitored environment such as an ICU on patients with high risk so it is presumed that if an alarm were to go off, action would be taken.


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.’

Presenter

Presentation Notes

IVDD deviation does not contain the parenthetical language. 6.2: Mfr shall identify risk control measure(s) that are appropriate for reducing the risk(s) to an acceptable level. Deviation 6 is very similar to deviation 5. MDD & IVDD Control Options: Inherent safety by design Protective measures in the medical device itself or in the manufacturing process Information for safety


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

Presenter

Presentation Notes

This is an example of a mesh dFMEA. Here, control measures are identified but it does not indicate whether the risks have been designed out if possible.


‘....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)

Presenter

Presentation Notes

IVDD does not contain parenthetical language. Finally, deviation 7. This one has raised a lot of questions for manufacturers. The international version of the standard regards information for safety to be one of the 3 control options for mitigating risk. However, the harmonized version of the standard states that while the user should be informed about residual risks, they should not be used to mitigate risks further.


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.

Presenter

Presentation Notes

In this rather extreme example, you can see that the only control identified for the risk of an emboli for this implant is an IFU warning. Hopefully, the mfr. has taken other steps to ensure that the implant will not introduce an emboli. This should be listed instead of IFU warning. Once the risk has been reduced as far as possible, acceptability needs to be judged. If there are residual risks, it should be determined if the user needs to be informed about these. If so, this information should not further reduce risk.


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

Presenter

Presentation Notes

This is not to say that elements of the IFU cannot be potentially utilized to mitigate risk. If elements such as instructions on how to implant the device are provided in the IFU, these may be an acceptable means to mitigate risk. The control measure should be clear, however, on how the IFU is being used for this to be considered acceptable.


BSI Audits


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


• 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


• 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


Questions


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).


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.


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.



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.



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.


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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