WHITEPAPER: Risk Management EN ISO 14971:2012 Implications .

WHITEPAPER:Risk ManagementEN ISO 14971:2012 –Implications for MedicalDevice ManufacturersWhite paper produced by MaetricsFor more information, please contact global sales 1 610.458.9312 1 877.623.8742With offices around the world 2014Maetrics, All Rights Reservedglobalsales@maetrics.comwww.maetrics.com

IntroductionRisk management is a fundamental step for medical device manufacturers todemonstrate compliance with the EU Directives for medical devices, ensuring thesafety of patients and users. Risk management has been conducted following theprinciples laid out in ISO 14971, yet since the advent of the new version of EN ISO14971:2012 - Medical devices – Application of risk management to medical devices,the additional clarification within the standard has led to a number of misconceptionsand confusion surrounding the implementation of the new standard by medical devicemanufacturers. Some frequently heard comments by manufacturers on the newversions of EN ISO 14971 are:“We must use dFMEA (design failure mode and effect analysis) and pFMEA(production or process FMEA) from now on.”“All identified risks must be eliminated.”“We cannot use Annex C questions as we used to.”“We can no longer use ALARP (as low as reasonably practicable) but must useALAP (as low as possible).”“All risks must be addressed by design changes from now on.”“We will have to go back and rewrite all our risk files.”“We are not allowed to put warnings in the IFU.”As can be seen from the comments, medical device manufacturers have been left insome cases scratching their heads about how exactly they were going to implementthe new standard. Did they need to rewrite all the risk analysis they had conducted sofar or did they just have to apply the new version of the standard to future riskmanagement activities? This white paper will help medical device manufacturesunderstand the changes made to the EN harmonized version of ISO 14971:2012 andprovide guidance on what is expected of medical device manufactures forcompliance with the standard, thereby separating the facts from the misconceptions.BackgroundThe current ISO (internationally recognized) version of the standard is ISO14971:2007, which is recognized by the FDA for managing risks associated withmedical devices. Any standard that carries the EN nomenclature indicates that it hasbeen harmonized to one or all of the European Directives with respect to theEssential Requirements detailed within an annex of the specific EN standard.The EN version of ISO 14971 had undergone a previous harmonization step in 2009with the inclusion of three “Z” annexes that described the relationship between thestandard and the three European Directives for medical devices. Essentially,compliance with the standard meant that all the Essential Requirements of the2

directives relating to risk and/or safety were covered by complying with the EN ISO14971 standard.EN ISO 14971:2012 was published as a result of objections being raised by theCompetent Authority in Sweden and the European Commission regarding theinconsistencies in the previous harmonized standard relating to the wording in thethree “Z” annexes.New standardThe main contents of the new version of the standard have not changed. Theadditional wording has focused around the annexes listed at the front of the standardthat explain the relationship of the standard to the relevant European Directives formedical devices. The risk management process has therefore remained the same, asreflected in the fact that the contents listed in the standard remain the same with thefollowing clauses:Clause 1: ScopeClause 2: Terms and DefinitionsClause 3: General Requirements, Including PlanningClause 4: Risk AnalysisClause 5: Risk EvaluationClause 6: Risk ControlClause 7: Evaluation of Overall Residual Risk AcceptabilityClause 8: Risk Management ReportClause 9: Production and Post-Production InformationTen annexes provide informative guidance with the standard, including the riskassessment process, questions for identifying safety hazards, risk concepts,examples of hazards, a risk management plan, risk management techniques andspecific guidance on in-vitro diagnostic devices, biological hazards andcommunicating residual risk safety information. In essence, the same steps are stilltaken by the manufacturer to conduct a risk assessment for a medical device, asfollows:a) Create a risk management plan (Clause 3.4).b) Identify the device characteristics (Clause 4.2 and Annex C).c) Identify the hazard and estimate risks (Clauses 4.3 and 4.4).d) Evaluate the risks identified (Clause 5).e) Develop appropriate risk control measures (Clause 6).f) Evaluate the overall risk for those identified (Clause 7).g) Prepare a risk management report (Clause 8).h) Maintain the risk file by gathering data in the production and post-productionphases (Clause 9).3

New AnnexesThe main change has been the additional details incorporated into the Annexes ZA,ZB and ZC that demonstrate how the EN ISO 14971:2012 standard helps themanufacturer comply with the three European Directives for medical devices: Medical Devices Directive 93/42/EEC (by Annex ZA)Active Implantable Medical Device Directive 90/385/EEC (by Annex ZB)In Vitro Diagnostic Medical Device Directive 98/79/EC (by Annex ZC)For ease of discussion, this white paper will refer to Annex ZA listed in the standardas the annex that relates to the Medical Devices Directive, and the same concept isused for the remaining directives detailed under Annexes ZB and ZC.The table listed under the ZA Annexes of the standard helps to explain where thestandard can be used and how far it goes in demonstrating compliance with theEssential Requirements detailed in the Medical Devices Directive. Where anydiscrepancies occur, they have also been highlighted. Unfortunately, the wording isbased on an interpretation by an assessor reviewing both the standard and thedirectives. Hence, a literal interpretation has been taken, providing an extrapolatedviewpoint instead of a practical approach of how to overcome the shortfalls, asevident in the discussion in table 1 of the “Z” Annexes as highlighted below.Discussion in Table ZA 1of ISO EN 14971:2012Essential requirementswording (MDD)Solution forManufacturerER 1, ER 5 and ER 7.1 arenot entirely covered byEN ISO 14971, since thestandard does notcover requirements ondesign, manufacture,packaging and doesnot cover performancesand characteristicsrelated thereto.The devices must bedesigned andmanufactured in such away that when usedunder the conditionsand for the purposesintended, they will notcompromise the clinicalcondition or the safetyof patients.Parts of ER 2 and ER 4are not directly coveredsince the standard doesnot providerequirements on designThe solutions adoptedby the manufacturer forthe design andconstruction of thedevice must conform toThe use of the questionslisted in Annex C of thestandard should be thestarting point formanufacturers’ riskanalysis, which is toidentify thecharacteristics of thedevice that may impactsafety as expected bythe standard andNotified Bodies.However, to address theshortfalls listed in Table 1of the ZA Annex, thefollowing should be4

Discussion in Table ZA 1of ISO EN 14971:2012and constructions, nordoes it apply theconcept of ‘safetyprinciples’ as intendedin the MDD.Essential requirementswording (MDD)safety principles The devices must bedesigned,manufactured andpacked in such a waythat their characteristicsand performances Solution forManufacturerconsidered:a) As well as answeringthe Annex Cquestions,incorporate somequestions around thedesign process andhow failures in theIt appears that thedesign process couldcommentary listed inimpact patientthe table has been usedsafety or produceas the exact wording inother harm.the Essentialb) For question C.2.28,Requirements yet haswhich requires a newnot been used in themanufacturingstandard. The intentionprocess to beof Essential requirementexplained, this should#1, however, could bebe improved byto indicate that devicesadding questionsare designed and areabout howmanufactured othermanufacturingthan highlightingprocesses andspecific aspects offailures could lead todesign andpatient or othermanufacture. The sameharm.principle is held forc) A question on“safety principles” andpackaging should bepackaging that are notincluded as there isincluded directly in thenot a specific onewording of thelisted in the Annex Cstandard.questions.d) A separate studycould be performedon design,manufacture andpackaging instead ofadding specificquestions to those5

Discussion in Table ZA 1of ISO EN 14971:2012Essential requirementswording (MDD)Solution forManufacturerlisted in Annex C ofthe standard. Thisapproach could beconducted using, forexample, FailureMode and EffectAnalysis (FMEA).e) If FMEAs areperformed, ensurethat any residual risksfound are transferredto the main risk tableand are evaluated inthe same manner asother risks.All of the clauses of the standard (1 – 9) are required to demonstrate compliance withthe Essential Requirements of the European Directives. However, not all of the partsof the Essential Requirements are covered by the standard as highlighted in the tableand additional documentation is required by the manufacturer to ensure fullcompliance with the essential requirements and hence the directives.6

Content DeviationsThe content deviations expand on the requirements detailed in the table listed in theZ Annexes covering the three medical device directives, and they identify where thenew standard’s definitions or content deviate from the Essential Requirements. Theshortfall of each content deviation will be explained and interpreted with a solutionthat the manufacturer can adopt to ensure compliance to the new standard isachieved.ContentDeviationTitleEN ISO14971:2012ClauseinterpretationInterpretation ofEssentialRequirements1 – Treatment Clause D 8.2of negligibleTherisksmanufacturermay discardnegligible risks.All risks regardlessof their dimensionneed to bereduced as muchas possible andneed to bebalanced,together with allother risks, againstthe benefit of thedevice.2–Discretionarypower ofmanufacturer as to theacceptabilityof risksAll risks have to bereduced as far aspossible and thatall risks combined,regardless of any“acceptability”assessment, needto be balanced,together with allother risks, againstthe benefit of thedevice.Clause 5, 6.1,6.4, 6.5 and 7Manufacturershave thefreedom todecide uponthe threshold forriskacceptability.Only nonacceptable riskshave to beintegrated intothe overall riskbenefit analysis.There is acontradictionSolution for theManufacturera) Instead of using“Insignificant” or“Acceptable” asthe lowestcategory of riskdefined within theplan, use thedefinition of “Low”as insignificant riskas detailed in D.8.5of the standard.b) This “Low” riskcategory is not justto capture risks thatare disregarded,and controlmeasures should stilltry to be applied.c) The plan detailsthat all risks will beinvestigated forfurther reductionand not just theones falling in the“High” or “Low”category.d) The use of “Low”,“Medium” and7