EN ISO 14971:2012 Impact Assessment
+1 510 397 9739
sam@lazzara.net
sam@lazzara.net
Link to Sam Lazzara's EN ISO 14971:2012 Flow Chart
Still trying to figure out what to do about EN ISO 14971:2012?
The ASQ Biomedical Division just published an article I wrote called Risky Business - Demystifying EN ISO 14971:2012. To view the article, go here.
Summary
EN ISO 14971:2012 became a European harmonized standard on August
30, 2012. The normative content is still in
accordance with ISO 14791:2007. However, the relationship between ISO 14971 and
the European Directives has changed as described in Annex ZA, ZB and ZC.
Compliance with the normative clauses in ISO 14971 does not ensure
conformity with the Essential Requirements (ERs) of the Directives. The Z Annexes
list “content deviations” between ISO 14971 and the ERs.
Background
EN ISO 14971:2012 is a harmonised European standard currently
supporting the following directives:
- Medical Device Directive (MDD, 93/42/EEC as amended)
- Active Implantable Medical Device Directive (AIMDD, 90/385/EEC as amended)
- In Vitro Diagnostic Medical Devices Directive (98/79/EC as amended)
Compliance with harmonised European standards provides a “presumption
of conformity” with the corresponding requirements of the associated Directive(s).
Manufacturers can use harmonised standards to meet the ERs or other provisions
of the Directives. However, the use of these standards remains voluntary. While
very uncommon, Manufacturers are free to choose other technical solutions to demonstrate
compliance with the mandatory legal requirements.
EN ISO 14971:2012 was published in July 2012 and superseded the
2009 version as a European harmonised standard in August 2012. The entry in the
Official Journal reads as follows:
EN ISO 14971:2012 Medical devices -
Application of risk management to medical devices
(ISO 14971:2007, Corrected version 2007-10-01)
(ISO 14971:2007, Corrected version 2007-10-01)
Manufacturer Recommendations
Manufacturers demonstrate their conformity with the Essential
Requirements (ERs) by preparing an ER Checklist that cross-references each ER
to compliance information. If a Manufacturer’s quality system procedures, ER
Checklist and Risk Management Report have already been found to be acceptable
by a Notified Body, one would think there should be no impact from the content
deviations. However, armed with the updated annex information in EN ISO
14971:2012, the Notified Bodies have new tools to assess the conformity of
Manufacturers’ risk management process with the directives.
Manufacturers should take the following steps immediately:
- Update risk management procedures as needed to address the deviations described in the applicable Z Annex.
- Update existing Risk Management Reports to comply with the deviations.
- Consider if design changes are needed to comply with the deviations. For example, since labeling can no longer be claimed to reduce risk, design provisions may be required to reduce the risk to acceptable levels.
- Update references to EN ISO 14971 that may appear in quality system documents including technical files.
Assessment of ISO 14971:2007 Content
Deviations versus Medical Device Directive Essential Requirements (in Sam’s
words)
Content Deviation per EN ISO 14971:2012
|
Questions To Determine Impact on Risk Management
(RM) Process
|
Practices Not Compliant with European
Interpretations
|
1.
Treatment of
Negligible Risks: ISO 14971 allows
negligible risks to be ignored. The Directives require all risks to be
reduced as far as possible and to be subject to risk-benefit analysis.
|
Does
RM process allow some risks to be considered negligible and therefore not
reduced by risk control measures?
{EN Compliant Answer = NO} |
Three
risk zones: Broadly Acceptable (BACC), Tolerable and Intolerable. No risk
reduction required for BACC risks.
|
2.
Risk
Acceptability Assessment: ISO 14971
allows risks that meet the manufacturer’s definition of “acceptable” to be
excluded from overall risk-benefit analysis. The Directives require all risks
to be reduced as far as possible and to be subject to risk-benefit analysis.
|
Does
RM process exclude any “acceptable” individual risks from the overall
residual risk evaluation or from risk-benefit analysis?
{EN Compliant Answer = NO} |
Only
“Intolerable” risks must be justified by risk-benefit analysis.
|
3.
Risk
Reduction Economic Considerations:
ISO 14971 allows risks to be reduced “as low as reasonably practicable”
(ALARP). The Directives require all risks to be reduced as far as possible
(AFAP) without economic considerations.
|
Does
RM process allow risk controls to be limited for economic reasons?
(EN Compliant Answer = NO) |
The
cost of implementing risk control measures is a factor in determining how to
reduce risks.
|
4.
Risk-Benefit
Analysis Not Optional: ISO 14971
only requires risk-benefit analysis for risks that do not meet the
manufacturer’s definition of “acceptable”. The Directives always require
risk-benefit analysis, regardless of risk levels. The analysis must consider
all individual risks and their impact on overall residual risk acceptability,
weighing all risks combined against patient benefit.
|
Does
RM process require an overall risk-benefit analysis for the device?
{EN Compliant Answer = YES} |
Only
“Intolerable” risks must be justified by risk-benefit analysis.
|
5.
Risk Control
Options: ISO 14971 describes three
risk control options to be exercised at the manufacturer’s discretion – (1)
inherent safety by design, (2) protective measures, and (3) information for
safety – and implies that further controls are not required if the risk is
reduced to acceptable levels. The Directives require risks to be reduced
until further control measures do not result in risk reduction.
|
Does
RM process require consideration of all possible risk control options,
without stopping as soon as risks are reduced to an acceptable level?
{EN
Compliant Answer = YES}
|
Design
measures and labeling warnings are implemented without considering protective
measures in the device or the manufacturing process.
|
6.
First Risk
Control Option: ISO 14971 describes
the first risk control measure as “inherent safety by design” without further
detail. The Directives provide additional detail by mentioning that device
design and construction must conform to safety principles, taking account of
the generally acknowledged state of the art and that risks must be eliminated
or reduced as far as possible through inherently safe design and
construction.
|
Does
RM process require risk elimination or reduction as far as possible through
inherently safe design and construction, and the application of safety
principles and state of the art?
{EN
Compliant Answer = YES}
|
Designing
device without awareness of all relevant standards.
|
7.
Labeling
Information Cannot Influence Residual Risk: ISO 14971 describes three risk control options: (1) inherent safety
by design, (2) protective measures, and (3) information for safety. The
Directives view the third option as providing information on residual risk
rather than reducing risk.
|
Does
RM process allow risks to be reduced through the provision of information for
safety?
{EN Compliant Answer = NO} |
Taking
credit for warnings in the device Instructions For Use as risk reduction
measures without verifying their effectiveness.
|
+1 510 397 9739
sam@lazzara.net
sam@lazzara.net
