IVDR Conformity Assessment Routes - BSI Group
IVDR ConformityAssessment RoutesGuideIVDR ConformityAssessment Routess Is/Im/Ir devicess IIa devicess IIb Annex VIII rule 12 devicess IIb implantable – Well-Established Technologies (WET)s IIb non-implantable non rule 12 devices (non WET)s IIb implantable devices (excluding WET)s III non-implantable devicess III implantable devicesom-made Class III implantable devicesom-made devices (excluding custom-made Class III implantable devices)s I devices (excluding Class Is/Im/Ir devices)Notified Body Assessmentsented in the conformity assessment flow chartsis based on our current understanding of the MDRthe time of publishing this document; subject to change.2481010141618202223The tables do not cover assessments under the conformity routesAnnex X (Type Examination) and Annex XI Part B (Product Verificatwhich may require additional tests or examinations of the devices.The tables present a generalization of the requirements based on tclassification of devices and some exceptions may apply.Inspiring trust for a more resilient world.
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ContentsIllustration of the classification rules as per Annex VIII of the IVDR 4Useful definitions 6Class A devices (excluding class A sterile) 7Class A sterile devices 8Class B devices (excluding self-testing and near-patient testing (NPT) devices) 10Class B self-testing and NPT devices 12Class C devices (excluding self-testing, NPT and companion diagnostics (CDx)) 14Class C self-testing and NPT devices 16Class C companion diagnostic (CDx) devices 18Class D (excluding CDx), with Common Specification 20Class D (excluding CDx), with no Common Specification 22Class D CDx devices 24Disclaimers: The information presented in this brochure is based on our current understanding of theIVDR requirements at the time of publishing and is subject to change The tables do not cover assessments under the conformity route of Annex XI (ProductionQuality Assurance). BSI is not designated to Annex X (Type Examination) The Competent Authority may ask for verification testing by the EU Reference Laboratoryfor devices other than Class D3
Illustration of the Classification rules as perRule 1Rule 2Rule eImplementingrulesBloodscreeningNBlood ortissuecompatibilityCompanionN diagnosticsGenetictestingHigh riskdiseaseCongenitalscreeningYDYCYHigh riskbloodgroupsYDNote: When classifying yourdevice, always consult the IVDRand, in particular, Annex VIII.4C
Annex VIII of the IVDRRule 4Rule 5Rule 6Rule 7Specific aclesYCSelf-test:Exempted(see below-right)None of theother rulesControls withno assignedvaluesYYYABBYBN Pregnancy tests Fertility tests Cholesterol testsClass B self-tests Detection of glucose,erythrocytes, leucocytesand bacteria in urineAll near patient tests areclassified in their own right, theycan be D, C, or B, depending onintended purpose.5
Useful definitionsCE 2797EU Reference LaboratoryThroughout this guide, our Notified Body isreferenced using its assigned Notified Bodynumber: BSI The Netherlands (2797).These have been introduced under theIVDR and are laboratories designated bythe European Commission to support withthe assessment of Class D IVD devices. AnEU Reference Laboratory is responsiblefor verifying the performance of Class DIVD devices and the ongoing verification ofmanufactured devices.Common SpecificationsThe European Commission provides CommonSpecifications to the IVDR as a means ofcomplying with the legal obligations applicableto a device, process or system, such as theGeneral Safety and Performance Requirements(GSPRs), the requirements for performancestudies and performance evaluation, and/orpost-market surveillance.CA and EMAIn the case of companion diagnostics, theCompetent Authority (CA) or the EuropeanMedicines Agency (EMA) will be consultedregarding the associated medicinal product.6The Competent Authority may ask forverification testing by the EU ReferenceLaboratory for devices other than Class D.Notified Body (NB)The role of BSI as a Notified Body is to conducta conformity assessment under the IVDR. Thisusually requires an audit of the manufacturer’squality management system and, dependingon the particular classification of the device, areview of the relevant Technical Documentationin support of the safety and performance claimsfor the device. The Technical Documentationis assessed against the General Safety andPerformance Requirements (GSPR) withinthe IVDR.
Class A devicesNote: No Notified Body involvementClass A(excluding steriledevices)Annex II and IIITechnicalDocumentationDeclaration of conformity(Annex IV)Self declarationCE Marking(Annex V)CE7
Class A sterile devicesClass AsterileAnnex II and IIITechnicalDocumentationAnnex XI*Annex IX* QMSProduction QualityAssuranceChapters I, IIIDeclaration of conformity(Annex IV)CE Marking(Annex V)CE 2797* Limited to sterility aspects8
Class A sterile devicesInitialConformityAssessmentY1Y2Y3Y4Y5QMS AuditsYesYesYesRecertification*YesYesMicrobiology AuditsYesN/AYesN/AYesN/ATechnical DocumentationAssessmentN/AN/AN/AN/AN/AN/ACompetent Authority or EMAconsultation (Annex IX, Section 5.2)N/AN/AN/AN/AN/AN/AExperts consultations(article 48(6))N/AN/AN/AN/AN/AN/AVerification by EU referencelaboratory (Annex IX, section 4.9)N/AN/AN/AN/AN/AN/ASummary of Safety andPerformance (Article 29)N/AN/AN/AN/AN/AN/AClass Asterile devicesSurveillancePerformance Evaluation Report updates(Annex XIII - Part A, Section 1.3.2 and Article 56)Not required for NB assessmentPost Market Performance Follow-up (PMPF) updatesEvaluation Report (Article 56 and Annex XIII, Part B)Not required for NB assessmentUpdated when necessary and made availableto the NB upon request.Post Market Surveillance (PMS) Report (Article 80)Periodic Safety Update Report (PSUR) (Article 81)Unannounced AuditsN/AN/AN/AN/AN/AAt least once every 5 years* Q MS certificates are valid for three years, whilst CE certificates remain valid for a maximum of five years. The Y3Recertification indicated in the table relates to the EN ISO 13485:2016 certificate cycle. Certification cycles varyand re-certification may not always occur at Y3.9
Class B devices(excluding self-testing and near-patient testing (NPT) devices)Class B(excluding class Bself-testing andnear-patienttesting)Annex IX QMSChapters I, IIIAnnex IX Chapter IITechnical Documentationassessed per device category(Section 4)Declaration of conformity(Annex IV)CE Marking(Annex V)CE 279710
Class B devices (excluding self-testing and NPT devices)Class B devices(excluding self-testingand NPT devices)QMS AuditsMicrobiology AuditsTechnical YesYes(if sterile)N/AYes(if sterile)N/AYes(if sterile)N/ASample perdevice categoryAs per the Technical Documentation Sampling Plan.A Technical Documentation surveillance audit is requiredevery year whilst there are still devices left to be reviewedunder the certificate scope.Competent Authority or EMAconsultation (Annex IX, Section 5.2)N/AN/AN/AN/AN/AN/AExperts consultations (article 48(6))N/AN/AN/AN/AN/AN/AVerification by EU referencelaboratory (Annex IX, section 4.9)N/AN/AN/AN/AN/AN/ASummary of Safety andPerformance (Article 29)N/AN/AN/AN/AN/AN/APerformance Evaluation Report updates(Annex XIII - Part A, Section 1.3.2 and Article 56)Updated as per Manufacturer’s Performance EvaluationPlan; NB to review as per Technical DocumentationSampling PlanPost Market Performance Follow-up (PMPF) updatesEvaluation Report (Article 56 and Annex XIII, Part B)Updated as per Manufacturer’s PMS, PMPF plans; NB toreview as per Technical Documentation Sampling Plan.Implementation of the PMPF plan will be verified duringannual surveillance visitsPost Market Surveillance (PMS) Report (Article 80)Updated when necessary and provided to the CA and/or NBupon requestPeriodic Safety Update Report (PSUR) (Article 81)Unannounced AuditsN/AN/AN/AN/AN/AAt least once every 5 years* Q MS certificates are valid for three years, whilst CE certificates remain valid for a maximum of five years. The Y3Recertification indicated in the table relates to the EN ISO 13485:2016 certificate cycle. Certification cycles varyand re-certification may not always occur at Y3.11
Class B self-testing and NPT devicesClass Bself-testing andnear-patienttestingAnnex IX QMSChapters I, IIIAnnex IX Chapter IITechnical Documentationassessed for every device(Sections 4 and 5.1)Declaration of conformity(Annex IV)CE Marking(Annex V)CE 279712
Class B devices self-testing and NPT devicesClass B devicesself-testing andNPT Y3Y4Y5YesYesYesRecertification*YesYesYes(if sterile)N/AYes(if sterile)N/AYes(if sterile)N/AReview for everydeviceN/AN/AN/AN/ARecertificationCompetent Authority or EMAconsultation (Annex IX, Section 5.2)N/AN/AN/AN/AN/AN/AExperts consultations (article 48(6))N/AN/AN/AN/AN/AN/AVerification by EU referencelaboratory (Annex IX, section 4.9)N/AN/AN/AN/AN/AN/ASummary of Safety andPerformance (Article 29)N/AN/AN/AN/AN/AN/AQMS AuditsMicrobiology AuditsTechnical DocumentationAssessmentPerformance Evaluation Report updates(Annex XIII - Part A, Section 1.3.2 and Article 56)Updated as per Manufacturer’s Performance Evaluation Plan; NB to review at the time of substantial changereviewsPost Market Performance Follow-up (PMPF) updatesEvaluation Report (Article 56 and Annex XIII, Part B)Updated as per Manufacturer’s PMS, PMPF plans; NB toreview at the time of substantial change reviewsPost Market Surveillance (PMS) Report (Article 80)Updated when necessary and provided to the CA uponrequest. NB to review at time of substantial change reviewsPeriodic Safety Update Report (PSUR) (Article 81)Unannounced AuditsN/AN/AN/AN/AN/AAt least once every 5 years* Q MS certificates are valid for three years, whilst CE certificates remain valid for a maximum of five years. The Y3Recertification indicated in the table relates to the EN ISO 13485:2016 certificate cycle. Certification cycles varyand re-certification may not always occur at Y3.13
Class C devices(excluding self-testing, NPT and companion diagnostics (CDx))Class C(excluding self-testing,near-patient testingand companiondiagnostics)Annex IX QMSChapters I, IIIAnnex IX Chapter IITechnical Documentationassessed per generic devicegroup (Section 4)Declaration of conformity(Annex IV)CE Marking(Annex V)CE 279714
Class C devices (excluding self-testing, NPT and companion diagnostics (CDx))Class C devices(excluding self-testing, NPTand CDx devices)QMS AuditsMicrobiology AuditsTechnical YesYes(if sterile)N/AYes(if sterile)N/AYes(if sterile)N/AAs per the Technical Documentation Sampling Plan.Sample per generic A Technical Documentation surveillance audit is requireddevice groupevery year whilst there are still devices left to be reviewedunder the certificate scopeCompetent Authority or EMAconsultation (Annex IX, Section 5.2)N/AN/AN/AN/AN/AN/AExperts consultations (article 48(6))N/AN/AN/AN/AN/AN/AVerification by EU referencelaboratory (Annex IX, section 4.9)N/AN/AN/AN/AN/AN/ASummary of Safety andPerformance (Article 29)YesUpdated as soon as possible, where necessaryPerformance Evaluation Report updates(Annex XIII - Part A, Section 1.3.2 and Article 56)Updated at least annually; NB to review as per TechnicalDocumentation Sampling PlanPost Market Performance Follow-up (PMPF) updatesEvaluation Report (Article 56 and Annex XIII, Part B)Updated as per Manufacturer’s PMS, PMPF plans; NB toreview as per Technical Documentation Sampling Plan.NB QMS audits to verify implementation of the plan bysampling complaints, vigilance information etc.Post Market Surveillance (PMS) Report (Article 80)Post-market surveillance will be captured in the PeriodicSafety Update ReportPeriodic Safety Update Report (PSUR) (Article 81)PSUR update required at least annually. The PSUR shouldbe available to the NB upon requestUnannounced AuditsAt least once every 5 years* Q MS certificates are valid for three years, whilst CE certificates remain valid for a maximum of five years. The Y3Recertification indicated in the table relates to the EN ISO 13485:2016 certificate cycle. Certification cycles varyand re-certification may not always occur at Y3.15
Class C self-testing and NPT devicesClass Cself-testing andnear-patienttestingAnnex IX QMSChapters I, IIIAnnex IX Chapter IITechnical Documentationassessed for every device(Sections 4 and 5.1)Declaration of conformity(Annex IV)CE Marking(Annex V)CE 279716
Class C devices self-testing and NPT YesRecertification*YesYesYes (if sterile)N/AYes(if sterile)N/AYes(if sterile)N/AReview for everydeviceN/AN/AN/AN/ARecertificationCompetent Authority or EMAconsultation (Annex IX, Section 5.2)N/AN/AN/AN/AN/AN/AExperts consultations (article 48(6))N/AN/AN/AN/AN/AN/AVerification by EU referencelaboratory (Annex IX, section 4.9)N/AN/AN/AN/AN/AN/ASummary of Safety andPerformance (Article 29)YesClass C self-testingand NPT devicesQMS AuditsMicrobiology AuditsTechnical DocumentationAssessmentSurveillanceUpdated as soon as possible, where necessaryPerformance Evaluation Report updates(Annex XIII - Part A, Section 1.3.2 and Article 56)Updated at least annually; NB to review at the time of PSURreviews or substantial change reviewsPost Market Performance Follow-up (PMPF) updatesEvaluation Report (Article 56 and Annex XIII, Part B)Updated as per Manufacturer’s PMS, PMPF plans; NB toreview at the time of PSUR reviews or substantial changereviewsPost Market Surveillance (PMS) Report (Article 80)Post-market surveillance will be captured in the PeriodicSafety Update ReportPeriodic Safety Update Report (PSUR) (Article 81)PSUR update required at least annually. The PSUR should beavailable to the NB upon requestUnannounced AuditsAt least once every 5 years* Q MS certificates are valid for three years, whilst CE certificates remain valid for a maximum of five years. The Y3Recertification indicated in the table relates to the EN ISO 13485:2016 certificate cycle. Certification cycles varyand re-certification may not always occur at Y3.17
Class C companion diagnostic (CDx)devicesClass CcompaniondiagnosticAnnex IX QMSChapters I, IIIAnnex IX Chapter IITechnical Documentationassessed for every device(Sections 4 and 5.2)CA or EMA consultationas per Annex IX – Section 5.2Declaration of conformity(Annex IV)CE Marking(Annex V)CE 279718
Class C companion diagnostic (CDx) devicesClass C companiondiagnostic (CDx)devicesQMS AuditsMicrobiology AuditsTechnical YesYes(if sterile)N/AYes(if sterile)N/AYes(if sterile)N/AReview for s to the devices may need supplementaryconsultations (determined on a case-by-case basis taking intoaccount the nature of the changes proposed)Competent Authority or EMAconsultation (Annex IX, Section 5.2)YesExperts consultations (article 48(6))N/AN/AN/AN/AN/AN/AVerification by EU referencelaboratory (Annex IX, section 4.9)N/AN/AN/AN/AN/AN/ASummary of Safety andPerformance (Article 29)YesUpdated as soon as possible, where necessaryPerformance Evaluation Report updates(Annex XIII - Part A, Section 1.3.2 and Article 56)Updated at least annually; NB to review at the time of PSURreviews or substantial change reviewsPost Market Performance Follow-up (PMPF) updatesEvaluation Report (Article 56 and Annex XIII, Part B)Updated as per Manufacturer’s PMS, PMPF plans; NB to reviewat the time of PSUR reviews or substantial change reviewsPost Market Surveillance (PMS) Report (Article 80)Post-market surveillance will be captured in the PeriodicSafety Update ReportPeriodic Safety Update Report (PSUR) (Article 81)PSUR update required at least annually. The PSUR should beavailable to the NB upon requestUnannounced AuditsAt least once every 5 years* Q MS certificates are valid for three years, whilst CE certificates remain valid for a maximum of five years. The Y3Recertification indicated in the table relates to the EN ISO 13485:2016 certificate cycle. Certification cycles varyand re-certification may not always occur at Y3.19
Class D with Common Specification(excluding CDx)Class Dwith CommonSpecificationAnnex IX QMSChapters I, III(excluding CDx)Annex IX Chapter IIexcluding Section 5*Technical Documentationassessed for every deviceVerification by EUReference LaboratoryAnnex IX – Section 4.9§Declaration of conformity(Annex IV)* For self-test and NPT Section 5.1is included§ equired for devices for whichRone or more EU ReferenceLaboratories have beendesignated in accordance withArticle 10020CE Marking(Annex V)CE 2797
Class D with Common Specification (excluding CDx)Class D with es(if sterile)N/AYes(if sterile)N/AYes(if sterile)N/AReview forevery deviceN/AN/AN/AN/ARecertificationCompetent Authority or EMAconsultation (Annex IX, Section 5.2)N/AN/AN/AN/AN/AN/AExperts consultations (article 48(6))N/AN/AN/AN/AN/AN/AVerification by EU referencelaboratory (Annex IX, section 4.9)YesModifications to the devices may need supplementaryverifications (determined on a case-by-case basis taking intoaccount the nature of the changes proposed)Summary of Safety andPerformance (Article 29)YesUpdated as soon as possible, where necessary(excluding CDx)QMS AuditsMicrobiology AuditsTechnical DocumentationAssessmentPerformance Evaluation Report updates(Annex XIII - Part A, Section 1.3.2 and Article 56)Updated at least annually. NB to review at the time of PSURreviews or substantial change reviewsUpdated as per Manufacturer’s PMS, PMPF plans; NB toPost Market Performance Follow-up (PMPF) updatesreview at the time of PSUR reviews or substantial changeEvaluation Report (Article 56 and Annex XIII, Part B)reviewsPost Market Surveillance (PMS) Report (Article 80)Post-market surveillance will be captured in the PeriodicSafety Update ReportPeriodic Safety Update Report (PSUR) (Article 81)PSUR update required at least annually; submitted to the NBvia EUDAMED for NB reviewUnannounced AuditsAt least once every 5 years* Q MS certificates are valid for three years, whilst CE certificates remain valid for a maximum of five years. The Y3Recertification indicated in the table relates to the EN ISO 13485:2016 certificate cycle. Certification cycles varyand re-certification may not always occur at Y3.21
Class D with no Common Specification(excluding CDx)Class Dwith no CommonSpecificationAnnex IX QMSChapters I, III(excluding CDx)Annex IX Chapter IIexcluding Section 5*Technical Documentationassessed for every deviceVerification by EUReference LaboratoryAnnex IX – Section 4.9§Expert consultation†* For self-test and NPT Section 5.1is included§ equired for devices for whichRone or more EU ReferenceLaboratories have beendesignated in accordance withArticle 100† here no Common SpecificationWis available, the NB shall providethe performance evaluationreport of the manufacturer to theExpert Panel within five days ofreceipt. Required in cases wherethe device is the first of its type22(Article 48(6))Declaration of conformity(Annex IV)CE Marking(Annex V)CE 2797
Class D with no Common Specification (excluding CDx)Class D with noCommon ntY1Y2Y3Y4Y5YesYesYesRecertification*YesYesYes(if sterile)N/AYes(if sterile)N/AYes(if sterile)N/AReview forevery deviceN/AN/AN/AN/ARecertificationCompetent Authority or EMAconsultation (Annex IX, Section 5.2)N/AN/AN/AN/AN/AN/AExperts consultations (article 48(6))Yes, if thedevice is thefirst ofits typeN/AN/AN/AN/AN/A(excluding CDx)QMS AuditsMicrobiology AuditsTechnical DocumentationAssessmentVerification by EU referencelaboratory (Annex IX, section 4.9)YesModifications to the devices may need supplementaryverifications (determined on a case-by-case basis taking intoaccount the nature of the changes proposed)Summary of Safety andPerformance (Article 29)YesUpdated as soon as possible, where necessaryPerformance Evaluation Report updates(Annex XIII - Part A, Section 1.3.2 and Article 56)Updated at least annually. NB to review at the time of PSURreviews or substantial change reviewsPost Market Performance Follow-up (PMPF) updatesEvaluation Report (Article 56 and Annex XIII, Part BUpdated as per Manufacturer’s PMS, PMPF plans; NB toreview at the time of PSUR reviews or substantial changereviewsPost Market Surveillance (PMS) Report (Article 80)Post-market surveillance will be captured in the PeriodicSafety Update ReportPeriodic Safety Update Report (PSUR) (Article 81)PSUR update required at least annually; submitted to the NBvia EUDAMED for NB reviewUnannounced AuditsAt least once every 5 years* Q MS certificates are valid for three years, whilst CE certificates remain valid for a maximum of five years. The Y3Recertification indicated in the table relates to the EN ISO 13485:2016 certificate cycle. Certification cycles varyand re-certification may not always occur at Y3.23
Class D CDx devicesClass DCDx devicesAnnex IX QMSChapters I, IIIAnnex IX Chapter IIincluding Section 5.2Technical Documentationassessed for every deviceCA or EMA consultation– Annex IX, Section 5.2Verification by EUReference LaboratoryAnnex IX – Section 4.9§Expert consultation†(Article 48(6))§† equired for devices for whichRone or more EU ReferenceLaboratories have beendesignated in accordance withArticle 100 here no Common SpecificationWis available, the NB shall providethe performance evaluation reportof the manufacturer to the ExpertPanel within five days of receipt.Required in cases where the deviceis the first of its type24Declaration of conformity(Annex IV)CE Marking(Annex V)CE 2797
Class D CDx devicesClass D CDx devicesQMS AuditsMicrobiology AuditsTechnical Y1Y2Y3Y4Y5YesYesYesRecertification*YesYesYes(if sterile)N/AYes(if sterile)N/AYes(if sterile)N/AReview forevery deviceN/AN/AN/AN/ARecertificationCompetent Authority or EMAconsultation (Annex IX, Section 5.2)YesExperts consultations (article 48(6))Yes, if no CSand the deviceis the first ofits typeSurveillanceModifications to the devices may need supplementary consultations (determined on a case-by-case basis taking intoaccount the nature of the changes proposed)N/AN/AN/AN/AN/AVerification by EU referencelaboratory (Annex IX, section 4.9)YesModifications to the devices may need supplementaryverifications (determined on a case-by-case basis taking intoaccount the nature of the changes proposed)Summary of Safety andPerformance (Article 29)YesUpdated as soon as possible, where necessary.Performance Evaluation Report updates(Annex XIII - Part A, Section 1.3.2 and Article 56)Updated at least annually; the NB will provide it to the expertpanel as needed. NB to review at the time of PSUR reviewsor substantial change reviewsPost Market Performance Follow-up (PMPF) updatesEvaluation Report (Article 56 and Annex XIII, Part BUpdated as per Manufacturer’s PMS, PMPF plans; NB toreview at the time of PSUR reviews or substantial changereviewsPost Market Surveillance (PMS) Report (Article 80)Post-market surveillance will be captured in the PeriodicSafety Update ReportPeriodic Safety Update Report (PSUR) (Article 81)PSUR update required at least annually; submitted to the NBvia EUDAMED for NB reviewUnannounced AuditsAt least once every 5 years* Q MS certificates are valid for three years, whilst CE certificates remain valid for a maximum of five years. The Y3Recertification indicated in the table relates to the EN ISO 13485:2016 certificate cycle. Certification cycles varyand re-certification may not always occur at Y3.25
Our website provides a wealth of resourcesincluding guidance documents, trainingcourses, webinars and whitepapers.To find out more, visitbsigroup.com/IVDVDR)lation (Iic ReguiagnostDroitIn-Vs ReviewNameReadinesContactCompanyAddressJob TitleTelephoneNameEmailn No.CertificatioDate:lation?IVD Regults thatain end resudown certState.ives layMemberEU Directd in everyr laws tobe achieveadapt theimusthave tochhow toauthoritiesIVDR, whito decideNationalnge. Thebut are freedye goals,ificant chae on MayHow reameet thesoing signinto forcis undergenteredindustry/79/EC),do so.years forEUThe IVDctive (98ct form ofiod of fivedireperIVD Diretnthemosssitioereplaces are thethey havts the tranEurope.passed,RegulationThis starices intothey areupdatery Member25th 2017.soon asing IVD devperiod tolaw - asughout eveurers selltransitionionall force thromanufactn of thethe newlaws. Natbinding legato meetnationalthe duratioeforseswithnonceshavactia parrerstransitioand proState, onhave to takeManufactuentationa smoothnotgumns.dourindoclatioentsreguhnicalted to ensgovernmlement EUtheir tecis commites to impnts. BSIthe IVDR.themselvtherequiremecertify toto meetwishing toyou intendall clientsuse indetail how, pleasews you toRegulationexhaustiveument allothe newNOT ancan helpofisThis docs.Itnts46.cess, butchangerequireme) 2017/7w tosition prosignificantadditionalulation (EUboxes belot of the tranents of then with Regy. Use thery statemto form parconjunction strategs summaas a gapnot needr transitiobe usedand doesbut containning youndatory. This canchecklistplanmantsformelnotisuireful tooitional reqbe a useof this formaddionandrthenpletsyou.resComntsly on inl preparatiothat addassessmer internar plans earexamplestransitionwith youabout youevision.ords anding yourtalk to usures, recmoire dur.com/IVDRRso pleaselist procedw.bsigroupan aide mejourney,tool or asn page wwon yourisioyourevtanalysisRporBSI IVDhere to supbe foundTeam istion canYour BSIr informan. Furthepreparatiofor theare you26
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YourYour resourceresource forfor excellenceexcellenceOfficesin 31 countriesaround theworld Over84,000clients operatingin 193countries Over84,000in unt for75%of the FTSE 100of theourFortuneand 77%of theofNikkei225 100 49%Togetherclients500accountfor 75%the FTSElistedcompanies49% ofthe Fortune 500 and 77% of the Nikkei 225 listedMore companiesthan 750 colleagues in BSI Medical Devices More than 750 colleagues in BSI Medical DevicesAdditional servicesAdditionalMedical deviceservicesnewsletter serviceKeep updatedwhat’s happeningMedicaldeviceonnewsletterservice in the industry andchangesin regulatoryandquality requirements.YouKeep updatedon what’shappeningin the industryandcantake inadvantageof andthis qualityfree serviceby signingYouupchangesregulatoryrequirements.on ourwebsite.cantakeadvantage of this free service by signing upon our website.Your resource in worldwide compliance: call BSI today on 44 345 080 9000bsigroup.com/medical– toyourYour resourceorinvisitworldwidecompliance: callBSIstarttodayonjourney. 44 345 080 9000or visit bsigroup.com/medical – to start your journey.BSI The Netherlands Notified Body (2797)SayBuildingBSI TheNetherlands Notified Body (2797)JohnM. Keynesplein 9Say Building1066EPKeynespleinAmsterdam 9John M.The Netherlands1066EP AmsterdamTheNetherlandsT: 3120 346 0780F: 31 20 346 07800781T:E: 31eu.medicaldevices@bsigroup.comF:20 346 0781E: eu.medicaldevices@bsigroup.comBSI Group America Inc.12950WorldgateBSI GroupAmericaDriveInc.Suite12950800Worldgate DriveHerndon,Suite800VA 20170USAHerndon,VA 20170USAT: 1 800 862 4977/703 437 9000F: 1 800703 862437 4977/7039001T:437 9000E: 1us.medicaldevices@bsigroup.comF:703 437 9001E: us.medicaldevices@bsigroup.comBSI UK Approved Body (0086)KitemarkCourt Body (0086)BSI UK nesKnowlhillMK5 8PPDavy Avenue,United KeynesKingdomMK5 8PPMiltonUnitedKingdomT: 44 345080 9000T: 44 1908814920345 0809000E:medicaldevices@bsigroup.comT: 441908 814920E: medicaldevices@bsigroup.comBSI Group Asia Pac– HongBSI Group AsiaPacKong23rdFloor,–CambridgeBSI GroupHong KongHouseTaiKooPlace,979 King’sRoad23rdFloor,CambridgeHouseIsland East.HongTaiKooPlace,979KongKing’s RoadIsland East. Hong KongT: 852 3149 3320F:274333208727T: 852 3149E:hk@bsigroup.comF: 8522743 8727E: hk@bsigroup.com.making excellence a habit. .making excellence a habit. 28BSI/UK/103/MD/0421/en/BLD We have 4,600 colleagues globally Wehavein4,600colleaguesgloballyOffices31 countriesaroundthe worldInformative webinarsHearregularwebinarsupdates from our experts on key topics;Informativelistenlive or listenback.Hear regularupdatesfrom our experts on key topics;listen live or listen back.Comprehensive whitepapersOurtechnical specialistscollaborate with externalComprehensivewhitepapersexpertsto bringyou the latestviews withand ernaloncomplexregulatoryexpertsto bringyou theissues.latestDownloadviews and yourunderstandingcomplimentarycopies now.oncomplex regulatoryissues. Download yourcomplimentary copies now.Medical device guidance documentsOuronlineguidancedocumentsprovide ndingthedocumentsregulatory requirementsforOuronline guidanceprovide assistancemedicaldevices. the regulatory requirements forin understandingmedical devices.StandardsBSIBritish Standards delivers leading-edge best practiceStandardssolutionsthe deliversdevelopmentand publicationofBSI BritishthroughStandardsleading-edgebest practicemorethanthrough59,000theStandardsand relatedproducts. ofsolutionsdevelopmentand publicationmore than 59,000 Standards and related products.Copyright 2020, The British Standards InstitutionTalk to BSITalk to BSI
Class Is/Im/Ir devices 2 Class IIa devices 4 Class IIb Annex VIII rule 12 devices 8 Class IIb implantable – Well-Established Technologies (WET) 10 Class IIb non-implantable non rule 12 devices (non WET) 10 Class IIb implantable devices (excluding WET) 14 Class III non-implantable devices 16 Class III implantable devices 18 Custom-made Class III implantable .
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2016 Q1/Q2 Trilogue concludes Agreement on MDR & IVDR 2016 Q3/Q4 EC Administration Translation into all EU languages 2016 Q4 2017 Q1 EU MDR & IVDR Enter into force 3 year transition for MDR and 5 year transition for IVDR 17/03/2016
Security (BSI) was established by the German Parliament in 1991. § 3 of the Act on the Establishment of the BSI, dated 17.12.1990 (Federal Law Bulletin I p. 2834) defines the tasks of BSI. The Federal Office for Information Security (BSI) was established by the German Parliament in 1991. 3 of the Act on the Establishment
1. There is a toolbox of conformity assessment approaches intended to meet a range of needs. 2. Conformity assessment program models vary based on balancing risk and resources. 3. Software and cybersecurity bring challenges to conformity assessment. Certain commercial products, organizations and websites are identified.
2018-11-09 Enc 13 - 20181109 ISO9001 BSI Report 4 Audit Com cover Unrestricted Audit Committee Meeting, 20 November 2018 BSI ISO9001:2015 audit Executive summary and recommendations Introduction BSI have been on site to carry out the ISO9001:2015 audit. . ISO 9001:2015 AUD 58/18 Page 2 of 24. Assessment Report. Page 2 of 23
n Flute, Jazz Flute* n Oboe n Clarinet, Jazz Clarinet* n Bassoon n Saxophone, Jazz Sax* Grades 1–8: Instrumental and singing exams Practical syllabuses are available in over 35 subjects, from Piano to Percussion, and from Harpsichord to Horn. There is a separate Jazz syllabus for Flute, Clarinet, Sax, Trumpet, Trombone, Piano and Ensembles.
