MEDICAL DEVICE SEMINAR ISO 13485:2016 & MDR
MEDICAL DEVICE SEMINARISO 13485:2016 & MDRMay 2016
PresentersFergal O’ByrneHead, Business Excellence, NSAISusan MurphyEuropean Medical Device Operations ManagerMary MurphyLead Auditor, Medical Device DepartmentAishling OwensLead Auditor, Medical Device DepartmentLisa MeeLead Auditor, Medical Device Department
Certification Overview
Welcome to NSAI - Aims of the morning A time of change for many CertificationManagement Standards Understanding changes & their impacts Management Standards – general ISO 13485:2016 Medical Devices -QMS@NSAI Standards
Why change ISO Standards? ISO Review and Revise to support ContinualImprovement and Best Practice – the HLS ISO has supported the mantra of ‘Integration’ formany years – the HLS. See ISO guide NSAI audits, reports and audit teams delivered anintegrated service – the HLS in practice Standards needed to catch up–32 HLS MS by now
Management Systems CertificationMain Certification schemes –a time of great change All HLS ISO 9001:2008 to 2015, Quality ISO 14001:2004 to 2015, Environment OHSAS 18001:2007 to ISO 45001:2016/17 OccupationalHealth & Safety Three year transition period – period of co-existence Common Language Common Structure - HLS Ease of integration Reduced: work, costs, less disruption, betterunderstanding Aligned with the business - a Business Standard
Order out of Chaos
High level structure12345678910ScopeNormative referencesTerms and definitionsContext of the ormance evaluationImprovement
High level structure (1)Context nceEvaluationSupport(7)(9)Operations(8)
ISO 13485:2016 – odd one out ISO 13485:2016 revised but not in line with the HLS ISO TC 210 ducked the HLS for 3 and possibly 5 years ISO 9001:2015 and ISO 13485:2016 no longer in line Need to map the gaps – guidance to follow
NSAIDedicated NSAI teamJackie Mateer – Medical DevicesE: jackie.mateer@nsai.ie T:01 8073861Gwen Thornberry – Medical DevicesE: gwen.thornberry@nsai.ie T:01 8073929Jennifer Casey – General Management SystemsE: jennifer.casey@nsai.ie T: 01 8073817Patricia Whelan – General Management SystemsE: patricia.whelan@nsai.ie T: 01 8073993Events: ‘A Clients perspective’ ISO 9001:2016 & ISO 14001:2015 – Autumn 2016 QI Conference November 2016ISO 45001:2016/17 ‘Understanding the Changes’
ISO 13485:2016
Are you ready forISO 13485:2016?New TechnologiesNew RegulationsNew Era
What’s New in ISO 13485:2016? ISO 13485:2016 did NOT follow ISO 9001:2015into the Higher Level Structure format ISO 9001:2015 now has 7* QS core “Processes” ISO 13485:2016 retains 5* QS core “Processes” Annex B of ISO 13485:2016 provides a handycross-reference between ISO 9001:2015 andISO 13485:2016 normative requirements.*(excluding: Scope, Normative References, Terms & Definitions)
What’s New In 2016?Introduction - General The standard “can be used by an organization involvedin one or more stages of the life-cycle of a medicaldevice” And, by suppliers and other external partiesproviding product to such organizations
What’s New In 2016?Section 1 – Scope 1.2 - Any requirement of Clause 6, 7, or 8 can bedeemed “not applicable” to the organization(with documented justification)
What’s New In 2016?Section 1.2 – Scope Of Particular Note in 1:“The processes required by this International Standard thatare applicable to the organization, but are not performedby the organization, are the responsibility of theorganization and are accounted for in theorganization’s quality management system bymonitoring, maintaining, and controlling theprocesses.”
What’s New In 2016?Section 4 - Quality Management System4.1 – General (software): New Technologies 4.1.6 – Requires documented procedures for thevalidation of software used in the Quality ManagementSystem 4.1.6 – Such software shall be validated prior to initialuse, and as appropriate, after changes
What’s New In 2016?Section 4 - Quality Management System*4.2.3 - Medical Device File: For each medical device type or medical devicefamily, the organization shall establish and maintaina file(s) either containing or referencing documentsgenerated to demonstrate conformity with therequirement of this International Standard andcompliance with applicable regulatory requirements. Regular references to the regulatory requirements(*New sub-clause)
What’s New In 2016?Section 6 - Resource Management6.2 – Human Resources/ Competence The organization shall document the process(s) forestablishing competence, providing neededtraining, and ensuring awareness of personnel6.3 – Infrastructure: The organization shall document the requirementsfor the infrastructure needed to achieve conformity toproduct requirements, prevent product mix-up andensure orderly handling of product
What’s New In 2016?Section 7.3 - Design and Development7.3.2 – Design and Development Planning The organization shall plan and control the designand development of product During design and development planning, theorganization shall document: the methods to ensure traceability of design anddevelopment outputs to design and developmentinputs; and the resources needed including necessarycompetence of personnel
What’s New In 2016?Section 7.3 - Design and Development7.3.6 – Design and Development Verification The organization shall document verification plans If the intended use requires that the medicaldevice be connected to, or have an interface with,other medical device(s), verification shall includeconfirmation that the design outputs meet designinputs when so connected or interfaced Verification shall be completed prior to release for useof the product to the customer
What’s New In 2016?Section 7.3 - Design and Development7.3.7 – Design and Development Validation The organization shall document validation plans Design validation shall be conducted onrepresentative product Validation shall be completed prior to release for use ofthe product to the customer
What’s New In 2016?Section 7.3: Design and Development*7.3.8 – Design and Development Transfer The organization shall document procedures fortransfer of design and development outputs tomanufacturing. Results and conclusions of the transfer shall berecorded (see 4.2.5)(*New sub-clause)
What’s New In 2016?Section 7.3 - Design and Development7.3.9 – Control of Design and Development Changes The organization shall document procedures to control design anddevelopment changes. The organization shall determine thesignificance of the change to function, performance,usability, safety and applicable regulatory requirements forthe medical device and its intended use
What’s New In 2016?Section 7.3 - Design and Development7.3.9 – Control of Design and Development Changes(cont’d) The review of design and development changes shallinclude evaluation of the effect of the changes onconstituent parts and product in process or alreadydelivered, inputs or outputs of risk management andproduct realization processes
What’s New In 2016?Section 7.3: Design and Development*7.3.10 – Design and Development Files The organization shall maintain a design anddevelopment file for each medical device type ormedical device family(*New sub-clause)
What’s New In 2016?Section 7.4 - Purchasing7.4.1 – Purchasing Process The organization shall establish criteria for the evaluationand selection of suppliers The organization shall plan the monitoring and reevaluation of suppliers Non fulfillment of purchasing requirements shall beaddressed with the supplier proportionate to the riskassociated with the purchased product and compliancewith applicable regulatory requirements
What’s New In 2016?Section 7.4 – Purchasing7.4.2 – Purchasing Information Purchasing information shall include, as applicable, awritten agreement that the supplier notify theorganization of changes in the purchased productprior to implementation of any changes that affectthe ability of the purchased product to meet specifiedpurchase requirements
What’s New In 2016?Section 7.4 – Purchasing7.4.3 – Verification of Purchased Product The extent of verification activities shall be based onthe supplier evaluation results and proportionate tothe risks associated with the purchased product When the organization becomes aware of anychanges to the purchased product, the organizationshall determine whether these changes affect theproduct realization process or the medical device
What’s New In 2016?Section 7.5 - Production & Service Provision7.5.4 – Servicing Activities The organization shall analyze records of servicingactivities carried out by the organization or itssupplier:a. to determine if the information is to be handledas a complaintb. as appropriate, for input to the improvementprocess
What’s New In 2016?Section 7.5 - Production & Service Provision7.5.6 – Validation of Processes The specific approach and activities associated withsoftware validation and revalidation shall beproportionate to the risk associated with the use ofthe software including the effect on the ability of theproduct to conform to specifications
What’s New In 2016?Section 7.5 - Production & Service Provision7.5.8 – Identification The organization shall identify product status with respectto monitoring and measurement requirements throughoutproduct realization If required by applicable regulatory requirements, theorganization shall document a system to assign uniquedevice identification to the medical device
What’s New In 2016?Section 7.5 - Production & Service Provision7.5.11 – Preservation of Product The organization shall protect product fromalteration, contamination or damage when exposedto expected conditions and hazards duringprocessing, storage, handling, and distribution
What’s New In 2016?Section 8 - Measurement, Analysis & Improvement8.2.1 – Feedback The organization shall document procedures for the feedbackprocess. This feedback process shall include provisions togather data from production as well as post-productionactivities The information gathered in the feedback process shall serve aspotential input into risk management
What’s New In 2016?Section 8 -Measurement, Analysis & Improvement*8.2.2 – Complaint Handling The organization shall document procedures fortimely complaint handling in accordance withapplicable regulatory requirements(*New sub-clause)
What’s New In 2016?Section 8 - Measurement, Analysis & Improvement*8.2.3 – Reporting to Regulatory Authorities If applicable regulatory requirements require notificationof complaints that meet specified reporting criteria ofadverse events or issuance of advisory notices, theorganization shall document procedures for providingnotification to the appropriate regulatory authorities(*New sub-clause)
What’s New In 2016?Section 8 - Measurement, Analysis & Improvement8.3 – Control of Nonconforming ProductNow contains 4 separate sub-clauses:1) 8.3.1 – General2) 8.3.2 – Actions in response to nonconformingproduct detected before delivery3) 8.3.3 - Actions in response to nonconformingproduct detected after delivery4) 8.3.4 – Rework (NOTE: same requirements as 2003 version)
What’s New In 2016?Section 8 - Measurement, Analysis & Improvement8.5.2 – Corrective Action The organization shall take action to eliminate the cause ofnonconformities in order to prevent recurrence. Anynecessary corrective actions shall be taken withoutundue delay The organization shall document a procedure to definerequirements for: Verifying that the corrective action does not adverselyaffect the ability to meet applicable regulatoryrequirements or the safety and performance of themedical device
SummaryA. Regulatory RequirementsB. CompetenceC. Design controlsD. Purchasing controlsE. Software validation
Comparison betweenISO 13485:2016 & ISO 9001:2015ISO 9001:2015ISO 13485:2016StructureFollow the HLS with 7 processesRetains 5 processesScopeMeet customer requirementsMeet customer requirements ®ulatory requirementsFocusContinual Improvement toenhance customer satisfactionContinuing suitability, adequacy andeffectiveness of QMS & safety andperformance of the Medical DevicePersonnel Retains need for Management RepSee Annex B to see the mapping of 9001 to 13485 (and visa versa) Use this as a basis for your company gap analysis.www.NSAIinc.com
Comparison betweenISO 13485:2016 & ISO 9001:2015Clauses not directly mapped in ISO 9001 are:Cleanliness of productInstallationServicingParticular requirements for sterile medical devicesParticular requirements for validation of processes forsterilisation & sterile barrier systems *New to ISO 13485:2016 – Medical Device File
ISO 13485:2016Transition Policy
Current Situation ISO 13485:2003 EN ISO 13485:2012
Regulatory requirements ISO 13485:2003 CMDCASAustraliaJapanMDSAP EN ISO 13485:2012 EU
Co-existence period ISO 13485:2016, replaces ISO 13485:2003and incorporates the Technical CorrigendumISO13485:2003/Cor. 1:2009
Co-existence period ISO 13485:2003 & ISO 13485:2016 willco-exist for a 3 year period Effective March 1st 2018, ISO 13485:2003certificates will no longer be issued byNSAI
Co-existence period Effective March 1st 2019 all ISO 13485:2003certificates will become invalid Effective until March 1st 2018 any new,modified or revised ISO 13485:2003 issuedby NSAI will have an expiry date not toexceed 1st March 2019
Manufacturer’s responsibility Carry out a gap analysis between ISO13485:2003 &ISO 13485:2016 Update QMS to the requirements of ISO13485:2016 Request registration to ISO 13485:2016from your registrar
Registrar’s responsibility Develop a checklist to help the manufacturersmeet compliance to ISO 13485:2016 Carry out upgrade audits either at the nextsurveillance or re-assessment audit Two years following publication, newregistrations will be issued only to ISO13485:2016 Three years following implementation of ISO13485:2016, ISO 13485:2003 will bewithdrawn
EN ISO 13485:2016 Refer to the Official Journal (OJ) for updates In the meantime EN ISO 13485:2012remains valid
Changes to the RegulatoryframeworkARE YOU READY ?
Current situation Both regulations are in the final stages of thelegislative procedure and are estimated to finishsometime in 2016, allowing them to come intoeffect by the end of 2016 or early 2017 Some time will be needed to polish the agreed textand have it translated into the official EU Languages
Why Change from Directives toRegulations? High profile vigilance cases with hips Pelvic floor meshes exposé by British Newspapers Discovery of fraud in PIP breast implants using lowquality “industrial grade” silicone oil
Why Change from Directives toRegulations?OutcomeMore focus on Notified Bodies through the; Commission recommendation 2013-473 Annex I product assessment Annex II on QMS assessment Annex III Unannounced audits Implementing regulation 920/2013 on the designationand monitoring of Notified Bodies
New Monitoring mechanism ofNotified Bodies All Notified Bodies are to be re-designated per therequirements of 920/2013 The audit team comprise representatives of Food and Veterinary Office (FVO) NB’s Competent Authority 2 other CA’s The designation is valid for 5 years unless the NB wants toextend their scope All results available on the NANDO website:ec.europa.eu/growth/tools-databases/nando
What the FVO foundSummary of audit findings Insufficient evidence that staff employed for conformityassessment activities were appropriately qualified andexperienced for the task Thoroughness of NB’s review of manufacturer’s clinicalevaluations The sampling and depth of review of technical files forClass IIA & Class IIB Devices The overall documentation and traceability of thecertification process was not always deemed appropriate
Output from FVO Some Notified Bodies have been de-designated Some Notified Bodies have elected to stop certificationactivities due to constraints of the new system Some Notified bodies have scope reductions / limitationsto their operation Exclusion of medical devices in class III Subset of devices within a NANDO designation Medical devices including the Machinery Directive to includeactive medical devices only
What lies ahead?
Chapter 1 DefinitionsSignificant changes ahead Products currently not classified as medical devices under theMDD will be included in the MDR Accessories will now include devices that specifically ordirectly assist another device in its intended purpose Custom made excludes mass produced by industrial means Inclusion of products containing non-viable human cell ortissue derivatives Importantly non medical devices with a risk profile similarto medical devices e.g. aesthetic implants, cosmetic laserproducts and contact lenses (Annex XV )
Common Specifications (CS)Where No Harmonised Standard exists Current standards are not sufficient Pertain to safety, performance and risk with aprominent focus on clinical data Applicable in AnnexAnnexAnnexAnnexAnnex1, safety and performanceII technical documentationXIII, Clinical evaluation and PMCFXIV Clinical evaluationXV Design requirements
Next stepsAestheticproducts perAnnex XVStandalonesoftware?What do I needto do?Custommade?Accessories
Annex XV, Products without anintended medical purposeReviewCSCE markdevicesperAnnex XVIdentifyAnnex XVdevicesUpdateQMSDeveloptechnicaldocs
Chapter II Making available of devices Obligations of economic operators Reprocessing CE Marking Free movement
ChangesResponsibleperson lityat all levels,includingauthorised repsEach person inthe supply chainwill have specificregulatoryresponsibility
Under DiscussionProduct liabilityinsurance for bothmanufacturers andAuthorised RepsUnderdiscussionReprocessing of singleuse devices (art 15)
Next stepsReprocessingRecallcriteria?Items toreviewNew QMSrequirements?OBLAccess toTechnicalfiles
Next stepsProductliabilitywithin thechainPersonresponsiblefor regulatorycomplianceItems toreviewReportingobligations ofimporters anddistributersAR contracts
Next stepsImplant cards,(information to beprovided to the patientwith an implanteddevice)Items toreviewPartsmanufacturersvs adverseeventsUpdate DOC,MDR modelavailable
Chapter IIIEudamed TraceabilityRegistrationPublication of device performanceUDI
ChangesSummary of safety and clinical performance Class 3 & implantsSummary to include Intended purposeDevice indications & contra-indicationsReference to standards and CSSummary of clinical evaluationsProfile and training of users
Next stepsManufacturer,authorised rep,economicoperatorPrepare forimplementationof EU UDITraceability/UDISingle UDI formanufacturers,AR & importersApply to thedevice andhigher levels ofpackaging for alldevices
Chapter VClassification Up classification NanotechnologySpinal disk replacementsLife saving AMDSubstance based devices
ChangesConformity assessment New Essential safety and performance requirementsMandatory tech file structure and contentClinical evaluation for all devices (not new)Scrutiny procedure for the most complex high riskmedical devices where no CS have been developed
Next stepsGap analysis ofall approveddevices on themarketClassificationReview andimplement newclassificationrequirementsAdapt newconformityassessmentwhere required
Chapter VINew concepts relating to Article 42 relates to following Annex VIII (full QA ) for allimplantables, (with the exception of sutures) Clinical evaluation and Clinical investigation processes arebetter defined Clinical investigations will be required for implantable andClass 3 devices with few exemptionsMandatory PMCF & PSUR(periodic safety update reports)
Chapter VIH
ISO 13485:2016 did NOT follow ISO 9001:2015 into the Higher Level Structure format ISO 9001:2015 now has 7* QS core “Processes” ISO 13485:2016 retains 5* QS core “Processes” Annex B of ISO 13485:2016 provides a handy cross-reference between ISO
The primary international version is ISO 13485:2003. The variant EN ISO 13485:2012 is the latest European harmonized version of ISO 13485; it replaces the prior harmonized version, EN ISO 13485:2003, which is now considered to be obsolete. EN ISO 13485:2012 is applicable only to manufacturers placing devices on the market in Europe.
ISO 13485 clauses 4.2.1, 5.4.1 Annex IX (Chapter I) 03 Quality Manual 9 03 Quality Manual ISO 13485 clauses 4.2.1, 4.2.2 04 Human Resources 10 04 Procedure for Human Resources ISO 13485 clause 6.2 11 04.1 Appendix 1 -Training Program ISO 13485 clause 6.2 12 04.2 Appendix 2 - Training Record ISO 13485 clause 6.2 13 04.3
resulting in the standard now having 10 clauses, where previously there were 8. The 3rd edition of ISO 13485 will keep the current clause structure and a new Annex is proposed for ISO 13485 to provide a clause by clause correlation between the new revisions of ISO 9001 and ISO 13485. The new revisions of both ISO 9001 and ISO 13485 have anFile Size: 375KB
ISO 13485:2016 Annexes Annex A Comparison of content between ISO 13485:2003 and ISO 13485:2016 – comments on changes Annex B Correspondence between ISO 13485:2016 and ISO 9001:2015 – top level clause mapping European Annexes - ZA (AIMD), ZB (MDD) and ZC (IVD) Identifies relationship between the European StandardFile Size: 855KB
ISO 13485 OPPOSED TO ISO 9001 _ As mentioned above, ISO 13485 is based on the structure of ISO 9001, even though it is a stand-alone standard. Despite that both standards are organized in the same way, ISO 13485 excludes ISO 9001 requirements related to continual improvement and customer s
ISO 13485:2016-based Quality Management System by clearing up any misconceptions regarding the standard'srequirements. . ISO 13485 has an additional set of requirements specific to the medical device industry, and it discards some of the requirements of the new ISO 9001. Therefore, compliance with ISO 13485 does not imply
ISO 9001:2008 –3 instances of the word “risk” ISO 9001:2015 –43 instances of the word “risk” ISO 13485:2003 –4 instances of the word “risk” ISO 13485:2016 –32 instances of the word “risk” “13485 Plus” is a guidance document that was publishe
archaeological resource within a particular area or 'site' in order to make an assessment of its merit in context (using the HER, historic maps and other resources) Post-excavation Assessment (PXA) It is fairly unlikely that you will need to produce one of these as they are generally a planning requirement and/or for large sites with lots of finds. A post- excavation assessment report should .
