CONF-16-Richard-Bancroft.pdf

1、Alignment of Global Medical Device Standards&TheirAcceptability for RegulatoryPurposesRichard BancroftSTERIS,Chair,ISO/TC 198Scott ColburnUS FDA,Chair,ISO/TC 210AcknowledgementThanks to Scott Colburn,U.S.FDA,who contributed to the scope and content of this presentation.FDA disclaimer:The views and o

2、pinions presented here represent those of the speakers and should not be considered to represent advice or guidance on behalf of the U.S.Food and Drug AdministrationContentsUse of standards Benefits WTO Alignment of regulatory principlesNational®ional standards,&primacy of international standards

3、 for relation to legal requirementsPotential risks to global standards Understanding and mitigating those risksConclusionBenefits of StandardsBarriers to global trade can be minimized by uniform technical standards The World Trade Organization(WTO)encourages use of international standards where they

4、 exist1International standards should take precedence over national standards,because international standards can be used to align multiple nations standards Can be used to meet regulatory requirementsVoluntary unless explicitly stated in a regulation(i.e.,harmonised symbols in MDR,13485 in FDA QMSR

5、1.World Health Organization,Article 20,General Agreement on Tariffs and TradeUse of StandardsBenefits to use of Standards Alignment with regulatory&customer expectations Less data and technical documentation needed to be provided to regulatory bodies Facilitates procurement&tender processes Tried&te

6、sted best practices help ensure complianceImplications of not using Standards Delays in device approval due to missing features or requirements Competitive disadvantage Restricts access to markets More cost,time and resource Decreased user confidenceStandards and WTOTransparencyInformation regarding

7、 current work as well as proposals for standards,guides and recommendations under consideration should be accessible to all interested partiesOpennessMembership of an international standardizing body should be open on a non-discriminatory basis to relevant bodiesImpartialityand ConsensusProvision of

8、 opportunities to contribute to development of an international standard.Consensus procedures should take into account the views of all parties concernedEffectiveness and RelevanceInternational standards need to be relevant and to effectively respond to regulatory and market needsCoherenceInternatio

9、nal standardizing bodies avoid duplication or overlap of work of other international standardizing bodiesDevelopment DimensionImpartiality and openness of standards development to ensure that developing countries are not excluded2.World Health Organization,Agreement on Technical Barriers to TradeThe

10、 World Trade Organizations(WTOs)Technical Barriers to Trade Committee2defines Six Principles for the development of international standards:International Regulatory ForumsThere is global agreement that international consensus standards are ideally suited to medical device development,manufacture and

11、 regulation,supported by:International Medical Device Regulators Forum(IMDRF)3,formerly GHTF Global Harmonization Working Party(GHWP)4,formerly AHWPBoth organisations focus on regulatory convergence around standards3.IMDRF,www.imdrf.org4.GHWP,www.ahwp.info ISO/IEC&CEN/CENELEC StandardsThe Internatio

12、nal Organization for Standards(ISO)&the International Electrotechnical Commission(IEC)have formal working agreements between its European counterparts,CEN&CENELEC:The Vienna Agreement5between CEN and ISO Frankfurt(formerly Dresden)Agreement6between CENELEC and IECThese agreements seek to:Make best u

13、se of available resources Increase transparency and cooperation Ensure international standardisation takes precedence over national standardisation Enable parallel approval of standards Recognise that European Union may have particular needs5.Vienna Agreement,ISO/CEN,19916.Frankfurt Agreement,IEC/CE

14、NELEC,2016Relationship of National&International StandardsUse of European StandardsInformative Z Annexes published in European standards as a requirement for harmonisationContain specific information required for the application of the relevant EU regulations by demonstrating how the standard addres

15、ses/covers the legal requirementsAnnex Z maps to MDR 2017/745Important for manufacturers who want to demonstrate compliance with the applicable EU regulation as they provide the presumption of conformity to the requirements of the regulationStandards published and subsequently updated with Annexes Z

16、 and harmonised are identified with+A11 This indicates that annexes Z have been added Standards published with Annexes Z and subsequently harmonised do not have this amendmentUse of European StandardsSOURCE:EN ISO 13485:2016+A11:2021Annex ZASOURCE:EN ISO 13485:2016+A11:2021HarmonisedPresumption of c

17、onformity to the legal requirements of a regulation(e.g.,MDR)by demonstrating compliance to a harmonised standardUsing an unharmonisedstandard requires explanation of compliance rationale in technical documentationSee MDCG 2021-5:Guidance on standardisation for medical devicesNeed a published Standa

18、rdisation Request(mandate)M/575Agreed on by Member StatesAddressed to CEN/CENELECCreate Annex Z crosslink table Informative but provides legal clarity Covered,partially covered,not coveredManufacturer identifies&implements additional actions to cover these requirementsInternational StandardsInternat

19、ional consensus standards such as those developed by ISO or IEC are preferred because they are crowd-sourced from experts around the worldThey are consensus-developed in a transparent and inclusive manner,which means that these standards reflect an agreement across borders Their technical content is

20、 best suited to ensure patient and public health,state of the art technology&thinking,and best practiceUS FDA RecognitionProcess of identifying standards that medical device manufacturers may submit a declaration of conformity to demonstrate relevant requirements in the FD&C Act have been met FDA ma

21、y recognize all,part,or none of a consensus standard Any interested party may submit a request for recognition to the FDA Recognition Number is assigned Supplemental Information Sheet is providedUK Designated StandardsUK Government designates standards for conformity with UKCA marking(or similar)leg

22、islationContains National Foreword and may contain a National Annex,showing correlation between standard and the relevant UK legislation,e.g.,UK Medical Devices Regulation S.I.2002 Similar annex to European Annex Z Dependent on new UK medical device regulation that has yet to be published as a S.I.W

23、ork in progressSOURCE:BS EN ISO 13485:2016+A11:2021Designated,Harmonised,RecognizedNeither designation,harmonisationnor recognition are automaticAdditional standards will be designated,harmonised and/or recognised in the futureThey simplify process for demonstrating conformity to legal requirements

24、in respective jurisdictionsAnnex NZ only found in UK(BSI)versionsAnnex Z only found in EN versionsRecognition only applies for US FDA purposesPotential Risks&Hurdles?National/regional pressures to modify/create local versions of standards can lead to an array of divergent versionsThese pressures ari

25、se from:Time taken to make changesDifferent regulatory requirementsDiverging views on state of the art&best practiceThis can obviate the benefits of relying upon the original consensus international standards in global commerceThese regional pressures can result in unintended consequences:Failure fo

26、r regulatory jurisdictions to designate/harmonise/recognize standardsDifferent requirements for the same device leading to duplicative devices and lack of interoperabilityCan lead to a global breakdown of uniform technical standardsMany European standards are adoptions of international standards fro

27、m ISO and IECIntent is to harmonise many standards via Standardisation Request,M/575Many US standards are adoptions of international standards from ISO and IECIntent is to recognize many standards via FDAs Recognized Consensus Standards ProgramChanges to the main text of these standards in order to

28、make them acceptable for regulatory purposes could have consequences for global alignment if these changes are not globally acceptable to the core international documentEuropean Union RegulatoryChangesSince the early 1990s,there was stability in the legal status of medical devices93/42/EEC(MDD),90/3

29、85/EEC(AIMDD)UNTIL the European Medical Device Regulation,2017/745(MDR),was enacted in 2017 with a three-year transitionextended in 2023The transition to the MDR means many European standards harmonised to the former MDD and AIMDD need now to be harmonised to the MDRThe European Commissions Standard

30、isation Request,M/575,lists 201 standards that need modification to be harmoniseddeadline of May 2024,expected to be extended to May 2028Currently,we have 16 standards harmonised to the MDR(and 10 standards to the IVDR)European Standards&the FutureChanges to standards are needed to align with the di

31、fferent MDR requirements Need to address sustainability?This may require:Changes to the technical content of the standard Minor amendments to a standards European annexes and/or European foreword addressing the presumption of conformityEuropean Standards&the FutureWhere changes are needed to the cor

32、e text of the standard,this requires a new edition in this instance,if the standards are European adoptions of international standards,these modifications must be consensus-accepted by ISO or IEC in order to maintain global alignment If these changes are not acceptable at ISO/IEC,we could be faced w

33、ith a European standard that differs from the international textIn a worst-case scenario,standards with almost identical title,scope and content could exist as different regional and international standardsFor globally marketed products,what will this look like?US Standards&the FutureIn order for a

34、document to be acceptable for regulatory purposes(FDA)and ultimately FDA recognition,an ISO or IEC document may not be adopted as a US national standard with identical ISO or IEC text This can result in the document being published as a US national standard with national deviationsThe standard will

35、have same standard number,but a different prefixFor example,ISO 15883-1 versus ANSI/AAMI ST15883-1Opportunities for confusion by standards users:RegulatorsManufacturersEnd usersStandards developersUse of Standards-SummaryDesignated(UK)UK process to support UKCA marking Process still being developed

36、Currently designated to Medical Device Regulations 2002 276 medical device standardsHarmonised(EU)EU process to support CE marking Harmonised to MDR and/or IVDR 250 standards requested for harmonisation by 2024/2028 Annex Z identified as+A11:2021 Maps the GSPR of the regulations and how they are cov

37、ered by the clauses and subclauses of the standardRecognised(US)US process for declaring conformity to regulations Supplemental Information Sheet(SIS)recognition number,extent of recognition,transition period for standard,rational for recognition No alignment/relationship to regulation provided othe

38、r than Extent of Recognition in SISMedical Device Law27,000 medical device manufacturers globally Largest medical device markets US,EU and Japan Growing markets China,South Korea,India and IsraelUS Federal Food,Drug,and Cosmetic Act(1938),Amended in 1962&1976 Established a regulatory framework for m

39、edical devices in the US Created US FDA Center for Devices and Radiological Health(CDRH)Demonstrate safety&effectiveness of devicesJapan-Regulation for medical devices(1945)Updated in 2014 Pharmaceuticals and Medical Devices Act(PMDA)Medical Device LawAustralia Therapeutic Goods Act(1989)2021 new IV

40、D regulationsEU Medical Devices Directives(1993)Separate directives for MD,IVDD and AIMD Replaced by Medical Device Regulation 2017/745 and In Vitro Device Regulation 2017/746Canadian Medical Device Regulations(1998)Outline the requirements for medical device licensing,labelling,and post-market surv

41、eillanceEuropean StandardsPresumption of conformityUse of standards(harmonised or not)is still voluntaryHoweverAnnex VII,4.5.1 of MDR/IVDR-“The notified body shall,where relevant,take into consideration available CS,guidance and best practice documents and harmonised standards,even if the manufactur

42、er does not claim to be in compliance”Harmonised standards=benchmark to evaluate manufacturers compliance to the legislative requirementThe Future Where changes are needed to the core text of the standard,this usually results in a new edition Where standards are adoptions of international standards,

43、these modifications must be made at ISO or IEC level and consensus-accepted in order to maintain global alignment It is unrealistic to expect exact alignment of global regulations for medical devices,but standards should be drafted to allow for:alignment to the different regulatory jurisdictions ser

44、ve as state of the art if recognized/harmonised serve as state of the art if the most recent edition National or regional annexes help by providing correlation to local legal requirements WITHOUT regional or national changes to the core textStandards Suitable for RegulatoryPurposesWhen drafting a ne

45、w standard,or a revision to an existing standard,the following are always considered:Application of the applicable CEN/CENELEC or ISO/IEC drafting rules Consensus agreement Development stagesWhat is often not considered:Applicable global regulations and means to address their requirements Caution wh

46、en drafting very specific requirements that may not be globally acceptable Drafting of a single requirement per clause or subclause Means for the standards user to easily demonstrate conformity to the standardIMDRF has specific recommendations for incorporating Essential Principles into standards de

47、velopment77.IMDRF Optimizing Standards for Regulatory Use,2018ConclusionTo facilitate global harmonization,any change to a consensus-developed standard should be considered an improvement to its technical content or to its utility for regulatory purposesAll actors involved in the preparation,impleme

48、ntation and use of standards should be aware of the global consequences of these actions,however well intendedGlobal alignment of the technical content of international standards benefits the standard user by:simplifying conformity with regulatory requirements reducing costs ultimately improving patient safety.