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Medical Device Regulation /In Vitro Diagnostic RegulationISO 13485:2016AlignmentSeptember 2016Stewart Brain and Linda Moon,BSICopyright 2016 BSI. All rights reserved.1

PresentersCopyright 2016 BSI. All rights reserved.Stewart BrainLinda MoonActing GlobalHead QMS –Medical DevicesQMSCertificationSpecialist –Medical Devices2

1 – MDR/IVDR update and timings2 – ISO 13485:2016 overview and timings3 – MDR/IVDR alignment with ISO13485:20164 - Conclusions3

MDR/IVDRUpdate and timings4

MDR/IVDR Update and timingsFinal text is unlikely tochange significantly fromthe consolidated textJune 2016 Consolidated text publishedMay 2016 EU reached political agreement2016201720182019202020212022Finalisation (publication in the Official Journal) estimated for late 2016/early 20173 year transition period for the MDR postfinalisation5 year transition period for the IVDR post finalisation5

IVDR UpdateAlignment of the MDR and IVDR ‘ There are specific features of in vitro diagnostic medical devices, inparticular in terms of risk classification, conformity assessmentprocedures and clinical evidence, and of the in vitro diagnostic medicaldevice sector which require the adoption of a specific legislation, distinctfrom the legislation on other medical devices, whereas the horizontal aspects common to both sectors should bealigned.’Copyright 2016 BSI. All rights reserved.6

ISO 13485:2016Overview andtimings7

ISO 13485:2016Medical Device Quality Management System (QMS)Standard published 26th February, 20168

Regulatory RequirementsISO 13485:2003ISO 13485:2016“Regulatory requirements”“Regulatory requirements”Appears 9 times*Appears 37 times** Within Normative Requirements, i.e. Clauses: 4 - 89

DefinitionsClause 3ISO 13485:2003ISO 13485:2016Active implantable medicaldeviceActive medical deviceAdvisory noticeCustomer complaintImplantable medical deviceLabellingMedical DeviceSterile medical deviceAdvisory noticeAuthorized representativeClinical evaluationComplaintDistributorImplantable medical deviceImporterLabellingLife cycleManufacturerMedical deviceMedical device familyPerformance evaluationPost market surveillancePurchased productRiskRisk managementSterile barrier systemSterile medical device10

Areas of Increased tion,Verification &DesignTransferOutsourcedProcesses &SupplierControlFeedbackImprovedlinkage ofclauses11

ISO 13485:2016 AnnexesAnnex A Comparison of content between ISO 13485:2003 and ISO 13485:2016Annex B Correspondence between ISO 13485:2016 and ISO 9001:2015European Annexes - ZA (AIMD), ZB (MDD) and ZC (IVD) Identifies relationship between the European Standard (EN ISO 13485:2016) andConformity Assessment Requirements of the respective EU Medical Device Directivesvia each conformity assessment route for each directive Annexes will need to be rewritten to address MDR and IVDR12

Late 2016?Cease issue ofnew ISO13485:2003Certificatesand recertificationsto ISO13485:200328 February 2019BS EN ISO13485:2016publishedEuropeanHarmonization28 February 2018ISO13485:2016published201626 February 2016ISO 13485:2016 – TimingsEnd of 3 yeartransition3 yeartransitionperiod nowstarted13

MDR/IVDRAlignment with ISO13485:201614

IMPORTANT NOTES The following slides give a flavour of how ISO 13485:2016 aligns with theMDR/IVDR and is NOT an exhaustive review ISO 13485:2016 is an international standard which is intended to beapplicable in jurisdictions worldwide Therefore it is not practicable for ISO 13485:2016 to cover all the Europeanquality management system requirements ISO 13485:2016 can be used as the basis to meet requirements howevermanufacturers must ensure that their QMS also meets the applicableEuropean regulatory requirements15

MDR/IVDR QMS Requirements Article 8 includes requirements for the QMS The requirements for the quality management system are expanded furtherin Annex VIII This section of the presentation will focus on alignment with ISO13485:2016 in the above sections As stated earlier manufacturers must ensure that their QMS meets all theapplicable European regulatory requirements16

MDR/IVDR Article 8General obligationsof the manufacturer17

Article 8 Clause 5 – Quality Management System Manufacturers shall proportionate to the risk class and the type ofdevice, manufacturers of devices, other than investigational devices,shall establish, document, implement, maintain, keep up to date andcontinually improve a quality management system that shall ensurecompliance with this regulation in the most effective manner The quality management system consists of all parts and components ofa manufacturer’s organisation dealing with the quality of processes,procedures and devices. It is managing the structure, responsibilities,procedures, processes and management resources to implement theneeded principles and actions to achieve compliance with the provisionsof this regulation.18

Article 8 Clause 5 – Quality Management SystemClause 5 – The quality management system shall address atleast the following aspects: a strategy for regulatory compliance, including compliancewith conformity assessment procedures and management ofmodifications to the devices covered by the system;ISO 13485:2016 – Not covered identification of applicable safety and performancerequirements and exploration of options to address these;ISO 13485:2016 – Clause 7.3.3 the responsibility of the management;ISO 13485:2016 – Clause 5 resource management, including selection and control ofsuppliers and sub-contractors;ISO 13485:2016 – Clause 6.1, 7.4.1 risk management;ISO 13485:2016 – Clause 4.1.2,7.119

Article 8 Clause 5 – Quality Management SystemClause 5 – The quality management system shall address atleast the following aspects: clinical / performance evaluation, including PMCF / PMPF;ISO 13485:2016 – Clause 7.3.7 product realisation, including planning, design, development,production and service provision;ISO 13485:2016 – Clause 7 control of UDI-Code assignments, ensuring consistency ofinformation provided;ISO 13485:2016 – Clause 7.5.8 setting-up, implementation and maintenance of a systematicPMS system;ISO 13485:2016 – Clause 8.2.1, 8.5.1 handling communication with competent authorities, notifiedbodies, other economic operators, customers and/or otherstakeholders;ISO 13485:2016 – Clause 7.2.3, 8.2.320

Article 8 Clause 5 – Quality Management SystemClause 5 – The quality management system shall address atleast the following aspects: processes for reporting of serious incidents and FSCA in thecontext of vigilance;ISO 13485:2016 – Clause 8.2.2, 8.2.3 management of corrective and preventive actions andverification of effectiveness;ISO 13485:2016 – Clause 8.5.2, 8.5.3 processes for monitoring and measurement of output, dataanalysis and product improvement.ISO 13485:2016 – Clause 821

MDR/IVDR AnnexVIIIConformityAssessment22

Annex VIII Chapter 1, Clause 1 – Quality Management System The manufacturer shall establish, document and implement a qualitymanagement system as described in Article 8(5) of this Regulation andmaintain its effectiveness through the life cycle of the devicesconcerned 23

Annex VIII Chapter 1 Clause 3.2 – Quality Management System Implementation of the quality management system shall ensure thecompliance with the provisions of this Regulation. All the elements,requirements and provisions adopted by the manufacturer for his qualitymanagement system shall be documented in a systematic and orderlymanner in the form of a quality manual and written policies andprocedures such as quality programmes, quality plans and qualityrecords.24

Annex VIII Clause 3.2 – Quality Management System Moreover, the documentation to be submitted for the assessmentof the quality management system shall include an adequatedescription of, in particular: (a) the manufacturer’s quality objectives;ISO 13485:2016 – Clause 5.4.1 (b) the organisation of the business and in particular: the organisational structures with clear assignment to procedures, theresponsibilities of the managerial staff and their organisationalauthority,the methods of monitoring the efficient operation of the qualitymanagement system and in particular its ability to achieve thedesired quality of design and of device, including control of deviceswhich fail to conform,where the design, manufacture and/or final verification and testing ofthe devices, or elements of any of these, is carried out by anotherparty, the methods of monitoring the efficient operation of the qualitymanagement system and in particular the type and extent of controlapplied to the other party,where the manufacturer does not have a registered place of businessin a Member State, the draft mandate for the designation of anauthorised representative and a letter of intention of the authorisedrepresentative to accept the mandate;ISO 13485:2016 – Clause 5.5ISO 13485:2016 – Cl. 7.3.5 8.2, 8.3ISO 13485:2016 – Clause 4.1.5, 7.4ISO 13485:2016 – Not covered25

Annex VIII Clause 3.2 – Quality Management System (c) the procedures and techniques for monitoring, verifying,validating and controlling the design of the devices and thecorresponding documentation as well as the data and recordsarising from those procedures and techniques, where theseprocedures and techniques shall specifically address: the strategy for regulatory compliance, including processes for identificationof relevant legal requirements, qualification, classification, handling ofequivalence, choice of and compliance with conformity assessmentprocedures,identification of applicable general safety and performance requirements andsolutions to address these, under consideration of applicable CS andharmonized standards or equivalent solutions,the risk management according to section 1a of Annex I,the clinical / performance evaluation, according to Article 49 and Annex XIII,including PMCF / PMPF,the solutions to address the applicable specific requirements regardingdesign and construction, including appropriate preclinical evaluation,addressing specifically Chapter II of Annex I,the solutions to address the applicable specific requirements regarding theinformation to be supplied with the device, addressing specifically ChapterIII of Annex I,the device identification procedures drawn up and kept up to date fromdrawings, specifications or other relevant documents at every stage ofmanufacture,management of design or quality management system changes;ISO 13485:2016 – Not coveredISO 13485:2016 – Clause 7.3.3ISO 13485:2016 – Clause 7.1ISO 13485:2016 – Clause 7.3.7ISO 13485:2016 – Clause 7.3ISO 13485:2016 – Clause 4.1/4.2ISO 13485:2016 – Clause 7.5.8ISO 13485:2016 – Cl. 4.1.4, 7.3.926

Annex VIII Clause 3.2 – Quality Management System (d) the verification and quality assurance techniques at themanufacturing stage and in particular: the processes and procedures which will be used,particularly as regards sterilisation and the relevantdocuments, (e) the appropriate tests and trials which will be carried outbefore, during and after manufacture, the frequency withwhich they will take place, and the test equipment used; itshall be possible to trace back the calibration of the testequipment adequately. In addition, the manufacturer shall grant the notified bodyaccess to the technical documentation referred to in AnnexII.ISO 13485:2016 – Clause 7.5. 8.2.6ISO 13485:2016 – Clause 7.5ISO 13485:2016 – Clause 7.4.3, 7.6, 8.2.6ISO 13485:2016 – Not covered27

Some examples of what is not covered in ISO 13485:201621 ISO 13485:2016does not explicitlyrefer to theEuropeanregulations ISO 13485:2016does not coverdetailed Europeanregulatoryrequirements forinclusion in theQMS e.g. labels,IFU, UDI, e, PMS,PMCF.3 ISO 13485:2016does not requirecontinualimprovement ofthe QMS28