During the process of harmonisation of ISO 14971: 2007 as an EN standard, it became apparent that the standard did not comply with all the requirements of the Medical Devices Directives (MDDs), namely 90/385/EEC, 93/42/EEC and 98/79/EC. Seven discrepancies were identified; these discrepancies are described in EN ISO 14971: 2012 as “Content Deviations”. Our newsletters to date have dealt with these seven Content Deviations.
In this blog, we review the Notified Bodies Recommendations Group (NBRG) Consensus Paper for the Interpretation and Application of Annexes Z in EN ISO 14971: 2012. This gives an insight into Notified Body thinking on the implementation of EN 14971
The NBRG Consensus paper which has Interim NBMed status, gives some very useful clarification and allows practical leeway on implementation when compared to a strict reading of the EN 14971 Annexes. Most notable among these are the clarifications given on the treatment of negligible risks, the use of ALARP, when to apply Risk Benefit Analysis and clarifying that “information on how to use a device safely may be considered a risk control measure”
The purpose of the paper is to “bridge the gap” between the interpretation of Annexes ZA, ZB and ZC of EN 14971 and “the practice of putting safe medical devices on the market in the EU and other countries where the MDDs apply”.
The document first off considers two aspects of the Annexes Z:
1) Reduce risk “as far as possible”: this has caused considerable confusion and this consensus paper “offers Notified Bodies and manufacturers an interpretation of “as far as possible” that is “clear, easy to understand and unambiguous.” (In line with Clause 1.1 of the 2013 edition of the European Commission, Parliament and Council’s Joint Practical Guide of the European Parliament, the Council and the Commission for persons involved in the drafting of European Union legislation)”
|Whereas the essential requirements and other requirements set out in the Annexes to this Directive, including any reference to ‘minimizing’ or ‘reducing’ risk must be interpreted and applied in such a way as to take account of technology and practice existing at the time of design and of technical and economical considerations compatible with a high level of protection of health and safety.|
The paper goes on to make specific recommendations for industry for the interpretation of each Content Deviation.
Content Deviation 1: Treatment of negligible risks:
Content Deviation 2: Discretionary power of manufacturers as to acceptability of risks:
Content Deviation 3: Risk reduction “as far as possible” versus “as low as reasonably practicable”:
Content Deviation 4: Discretion as to whether a risk-benefit analysis needs to take place:
Content Deviation 5: Discretion as to the risk control options:
“As stated above for Content Deviation 2, the manufacturer can justify ceasing further risk reduction where it is determined that the risk is acceptable”
“The manufacturer shall consider all risk control measures in Essential Requirement 2 that are appropriate to reduce the risk to an acceptable level. In so doing, the manufacturer shall document the control options in the priority order, as part of the risk management process.”
Content Deviation 6: Deviation as to the first risk control option
“The manufacturer shall ensure that, whenever possible, the first risk control option includes both safe design and safe construction.
Not relevant for compliance verification.“
Content Deviation 7: Information of the users influencing the residual risk
Content Deviation 7 states “..manufacturers shall not attribute additional risk reduction to the information given to the users…” However the NBRG Consensus Paper draws a distinction between information given to the user regarding safe use and disclosure of residual risk. The NBRG takes the view that Content Deviation 7 relates to the latter but not to the former. This effectively means that in the eyes of the Notified Body, information contained in Instructions for Use that details how certain risks can be avoid or reduced, can be considered as a risk control measure.
The NBRG Consenus paper states; “Any information for safety comprising instructions of what actions the user can take or avoid in order to prevent a hazardous situation from occurring may be considered a risk control measure. As required by Essential Requirement 13.1 of Directive 93/42/EEC (respectively ER B.8 of 98/79/EC) it may be considered as a risk control measure. The information includes the instructions for use, labels, etc. Since ‘safe use’ is related to risk control measures, the Medical Device Directives do not deviate in that regard from EN 14971. Any effects on risk reduction are to be documented by the manufacturer in the risk management file.
‘Disclosure of residual risk’ should be conducted in compliance with EN 14971 Clause 6.4, 6.5 and 7. The manufacturer shall not claim a reduction to the probability of harm when disclosing residual risk.
Compliance is checked by inspection of the risk management file.”
Recommendations for the Notified Body audit process – 6 pointers.
The paper give six specific pointers. “The Notified Bodies will focus on objective evidence on how manufacturers addressed the gaps (gaps between the requirements of the Directives and the Risk Management Standard (documented in the EN ISO 14971: 2012 edition) which must be addressed, if applicable) and modified their Risk Management Process accordingly. More specifically they will evaluate”:
To access the Notified Bodies Recommendations Group (NBRG) Consensus Paper for the Interpretation and Application of Annexes Z in EN 14971 use the link below.
Submitted by SQT Life Sciences Tutor John Lafferty
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