Sitem MDR Support Panel Tech Doc Reviewability
Sitem MDR Support PanelTech DocreviewabilityMichael Maier, Dipl.Ing., MBA, RACwww.medidee.comISO 9001 & ISO 13485Certified company1
Question: what is N 1 / N 2 / N 3 ?N 1: Trad. 510(k) ToC(1) Medical Device User Fee Cover Sheet (Form FDA 3601)(2) Center for Devices and Radiological Health (CDRH)Premarket Review Submission Cover Sheet (Form FDA3514)N 2: MDR ToC1. DEVICE DESCRIPTION AND SPECIFICATION, INCLUDINGVARIANTS AND ACCESSORIES1.1. Device description and specification(3) 510(k) Cover Letter1.2. Reference to previous and similar generations of thedevice(4) Indications for Use Statement (Form FDA 3881)2. INFORMATION TO BE SUPPLIED BY THE MANUFACTURER(5) 510(k) Summary or 510(k) Statement3. DESIGN AND MANUFACTURING INFORMATION(6) Truthful and Accuracy Statement4. GENERAL SAFETY AND PERFORMANCE REQUIREMENTS(7) Class III Summary and Certification5. BENEFIT-RISK ANALYSIS AND RISK MANAGEMENT(8) Financial Certification or Disclosure Statement6. PRODUCT VERIFICATION AND VALIDATION(9) Declarations of Conformity and Summary Reports6.1. Pre-clinical and clinical data(10) Device Description6.2. Additional information required in specific cases(11) Executive Summary/Predicate -------------------------------------(12) Substantial Equivalence Discussion7. The post-market surveillance plan drawn up inaccordance with Article 84.(13) Proposed Labeling(14) Sterilization and Shelf LifeN 3: IMDRF ToC8. The PSUR referred to in Article 86 and the post-marketsurveillance report referred to in Article 85(15) Biocompatibility(16) Software(17) Electromagnetic Compatibility and Electrical Safety(18) Performance Testing – Bench(19) Performance Testing – Animal(20) Performance Testing – ClinicalMedidee Services 2018ISO 9001 & ISO 13485Certified company2
Do you really want to be creative whensubmitting a 510(k) to the FDA ?Why do you then try to be creative with thetech.doc you submit to NB?ISO 9001 & ISO 13485Certified company
Conformity assessment – basics – general principlesTechnical Documentation :contains evidence for fulfillingGSPR evidence for conformity& state of the artlevel of scrutiny &sampling rateLow riskHigh riskISO 9001 & ISO 13485Certified company
GSPR (ER) – Risk Management – V&V – clinical evaluation - technicaldocumentationRisk ManagementGSPRGENERAL REQUIREMENTSREQUIREMENTS REGARDINGDESIGN AND MANUFACTUREREQUIREMENTS REGARDINGTHE INFORMATIONSUPPLIED WITH THE DEVICE?!?!?!MarketMedidee Services 2018ISO 9001 & ISO 13485Certified company5
General Safety and Performance Requirements (GSPR)Example (Regulations MDR* / edStandards(Annex Z)Fulfilment of therequirementsCHAPTER I. General Requirements1Devices shall achieve the performance intended by their manufacturer andshall be designed and manufactured in such a way that, during normalconditions of use, they are suitable for their intended purpose. They shall besafe and effective and shall not compromise the clinical condition or thesafety of patients, or the safety and health of users or, where applicable,other persons, provided that any risks which may be associated with theiruse constitute acceptable risks when weighed against the benefits to thepatient and are compatible with a high level of protection of health andsafety, taking into account the generally acknowledged state of the art.YesEN ISO 14971EN ISO 14155ISO 14708-1ISO 14708-3EN 60601-1EN 60601-1-2EN 62304EN ISO 13485Hazard Analysis ReportRisk Management ReportSystem Verification ReportClinical EvaluationEvidence ReportReportEN 60601-1 Test ReportEN 60601-1-2 Test Report2The requirement in this Annex to reduce risks as far as possible means thereduction of risks as far as possible without adversely affecting the benefitrisk ratio.YesEN ISO 14971Risk Management Report 11.3 .Devices labelled as sterile shall be processed, manufactured, packaged and,sterilised by means of appropriate, validated methods.Yes23.4Information in the instructions for use.YesEN 556-1EN ISO 11607-1EN ISO 11607-2EN 15223-1EN 1041:2008Product label designSterilisation validation planSterilisation validation reportIFUMedidee Services 2019ISO 9001 & ISO 13485Certified company6
Process & logical links - CE technical documentationUser RequirementSpecificationURS 01URS 02Functional RequirementSpecificationFRS 01.01FRS 01.02FRS 01.19Risk AnalysisRA 01.01.01RA 01.01.02RA 01.01.03FRS 02.01FRS 02.02FRS 02.09Clinical evaluationCL 01.01.01.01GR 1GR 2GR 13GSPR Medidee Services SAISO 9001 & ISO 13485Certified company
Medidee Services 2018ISO 9001 & ISO 13485Certified company8
Some examples of NB questions related totechnical documentationThe “grand classic”: Information xyz could not be located in thedocumentation submitted.The “it’s your job to match it”: The MFG claims conformity to ISOxyz:2016. The referenced test reports demonstrate conformitywith ISO xyz:2007. No rationale is given why and how the resultsobtained may be leveraged to fulfil the requirements of the 2016version of the standard.The “naïve 1”: There could no substantiation be located in thesubmitted documentation for the sample size chosen forvalidation of xyz.ISO 9001 & ISO 13485Certified company
Some examples of NB questions related totechnical documentationThe “Chinese connection”: Test report xyz referenced in sectionxyz of the GSPR does not relate to the device submitted.The “naïve 2”: The biological risk assessment and supportivereports cover the raw material but not the final medical device.The “clinical evaluation classic”: The indications do not excludepatients younger than x years – no clinical data is presentsubstantiating safety and performance in patients younger than x.ISO 9001 & ISO 13485Certified company
Conformity assessment– continuous process – you will have toupdatePMSPMCFRiskmanagementGSPR ok ?ISO 9001 & ISO 13485Certified company
Summary: Ensure Reviewability of tech.doc- Put yourself in the position of the reviewers and take intoaccount the review process at your NB !- Indicate clearly where to find the evidence (not “RiskManagement Report” but “RM Report, section 3.2 – page 8)- Ensure traceability between Specs, Risk Analysis, CER, GSPR- the V&V matrix is key- Use hyperlinks, make native searchable pdf, use consistentwording- Make meaningful summaries for each section – with links tothe further evidence- Provide Tech.Doc structure according Annex II and III if EUonly (check first with NB if you want to use IMDRF ToC)ISO 9001 & ISO 13485Certified company12
Tech Doc Requirements & NB reviewAnnex IIIAnnex IIAnnex VIIAnnex XI Part AAnnex VAnnex XI part BAnnex IV Annex VICE*except: except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectorsMedidee Services 2017ISO 9001 & ISO 13485Certified companyNo CEInvestigationalAnnex XArt. 62 – 81Annex XVClass III ImplantsAnnex IIAnnex XIIICustom MadeAnnex IXArticle 19: EU declaration of conformityClass IIISection 6 & 7 of part A always apply for sterile devicesImplants*Annex XI (part B product verification)Class IIbevery deviceClass IIaAnnex XI (part A production quality assurance)Class I s/m/rMDDNB involvementArticle 52 & Annexes IX, X, XIAnnex X (TE)Class Iat least one representative device for each category of devicesDeviceAt least one representative device per generic device groupTech.Doc.Annex II &IIIAnnex IX (Full QA Tech. doc)Tech. doc review by NBChoice of manufacturer, either ofMandatoryMDR13
Guidance TechnicalDocumentation sources/whitepapers/downloads/Medidee Services 2018ISO 9001 & ISO 13485Certified company14
ces/resources/whitepapers/Medidee Services 2018ISO 9001 & ISO 13485Certified company15
-devices-healthcare/medinfo-download-center#tab 1397654997088748131160Medidee Services 2018ISO 9001 & ISO 13485Certified company16
nical/imdrf-tech-190321-nivddma-toc-n9.pdfMedidee Services 2019ISO 9001 & ISO 13485Certified company17
Thank you for your attention!Medidee Services 2019ISO 9001 & ISO 13485Certified company18
View of a Notified BodyImpact of the MDR onthe assessment of TDsMedical Device Regulation2017/745Dr. Bassil AkraVP Global Strategic Business DevelopmentJanuary 14, 2020TÜV SÜD Product Service GmbH MEDICAL DEVICE REGULATION Copyright - Do not distribute without preapproval1January 2020
ndo/index.cfm?fuseaction directive.notifiedbody&dir id 34TÜV SÜD Product Service GmbH MEDICAL DEVICE REGULATION Copyright - Do not distribute without preapprovalJanuary 20202
Common understanding documents “Guidance Documents”Current StatusVarious Task Forces of the EU Commission are working on: Guidance on sampling of medical devices – PublishedExplanatory note on MDR codes – PublishedGuidance and templates for PSURsGuidance and template for SSCPs – PublishedGuidance on classification of Software as a Medical Device – PublishedGuidance and templates for PMCFsGuidance for sufficient clinical dataGuidance for equivalence approach – Gap Document to MEDDEV 2.7.1 Rev. 4Common specifications, Clinical Evaluation Guidance for Software, etc.Implementing act for reprocessing single use medical devicesTÜV SÜD Product Service GmbH MEDICAL DEVICE REGULATION Copyright - Do not distribute without preapproval 32 documents endorsed as of December 20199 documents on UDI2 documents on EUDAMED16 documents on Notified Bodies1 document on Clinical investigation and evaluation2 documents on new technologies4 documents on other topicsScheer guidelinesJanuary 20203
MDR – Article 120 Transitional ProvisionsTÜV SÜD Product Service GmbH MEDICAL DEVICE REGULATION Copyright - Do not distribute without preapprovalJanuary 20204
Technical documentation (TD) shall be presented in a Readily searchable 03Clear 01TÜV SÜD Product Service GmbH MEDICAL DEVICE REGULATION Copyright - Do not distribute without preapproval04 Unambiguous manner02 OrganizedJanuary 20205
TD Requirements: What does it include?Device descriptionInformation to be supplied by manufacturerDesign & manufacturing informationGeneral safety & performance requirementsProduct verification & validationAnnex III: TD on PMSTÜV SÜD Product Service GmbH MEDICAL DEVICE REGULATION Copyright - Do not distribute without preapprovalJanuary 20206
General requirements: Clauses 1-9SPR 1:Performance &safetySPR 5: Risksrelated to useSPR 2: Reductionof risksSPR 3: RiskmanagementsystemSPR 4: Riskcontrol measures& residual risksSPR 6: DevicelifetimeSPR 7:Packaging,transport, storageSPR 8: Riskbenefit ratioSPR 9: Devicesw/o medicalpurposeTÜV SÜD Product Service GmbH MEDICAL DEVICE REGULATION Copyright - Do not distribute without preapprovalJanuary 20207
Requirements regarding design & manufacture: Clauses 10-22SPR 10: Chemical,physical & biologicalpropertiesSPR 11: Infection µbial contaminationSPR 12: Devicesincorporating a medicinalproduct; substancesabsorbed or locallydispersedSPR 15: Devices with adiagnostic or measuringfunctionSPR 16: Protection againstradiationSPR 17: Electronicprogrammable systems &softwareSPR 18: Active devices &devices connected to themSPR 20: Protection againstmechanical & thermal risksSPR 21: Protection againstthe risks posed to thepatient or user by devicessupplying energy orsubstancesSPR 22: Protection againstthe risks posed by medicaldevices intended by themanufacturer for use bylay personsTÜV SÜD Product Service GmbH MEDICAL DEVICE REGULATION Copyright - Do not distribute without preapprovalSPR 13: Devicesincorporating materials ofbiological originSPR 14: Construction ofdevices & interaction withtheir environmentSPR 19: Particularrequirements for activeimplantable devicesJanuary 20208
Requirements regarding the information supplied with the device: Clause 2323.3. Information on packaging which maintains thesterile condition of a device (‘sterile packaging’)23.2. Information on the label23.1. GeneralrequirementsSPR 23:Label & IFUTÜV SÜD Product Service GmbH MEDICAL DEVICE REGULATION Copyright - Do not distribute without preapproval23.4. Information in IFUJanuary 20209
Clinical Aspects – Processes, Plans (P), Reports (R), Summary (S)ProcessPlanReport or SummaryLiterature SearchLSPLSRClinical InvestigationCIPCIR & CIRSClinical EvaluationCEPCERSSCPSafety and Clinical PerformancePost Market Clinical Follow UpPost Market rendIncident/ TrendPeriodic Safety UpdatePSURTÜV SÜD Product Service GmbH MEDICAL DEVICE REGULATION Copyright - Do not distribute without preapprovalJanuary 202010
First experience with MDRAuditing and Assessment ActivitiesTÜV SÜD Product Service GmbH MEDICAL DEVICE REGULATION Copyright - Do not distribute without preapprovalJanuary 202011
Auditing Manufacturer's often lack procedures on specific MDR requirements– Technical documentation requirements often not defined:– create the TD– update the TD– control the TD– Language requirements– Manuals / Labels / Information provided with the device– Information provided through Software User Interfaces– Information provided on the device– CE marking of devices (Hardware / Software)– Selection of applicable risk class and conformity assessment procedureTÜV SÜD Product Service GmbH MEDICAL DEVICE REGULATION Copyright - Do not distribute without preapprovalJanuary 202012
Technical documentation assessment Consistency was expected to be a huge issue, and it truly is.– Wording and consistency throughout the TD ofi. Intended purposeii. Indicationsiii.Contraindicationsiv.Risks, Remaining Risks, Risk Benefit ratiov. Claims (marketing materials vs. clinical evaluation report vs. verification testing) Completeness of TD–––––––––Promotional materials missingScoping of documents missing, e.g. in the CERLanguage requirements and translations incompleteProcess data not provided or incomplete (huge effort for manufacturers)Verification / Validation methods unclear or not provided (GSPR and general)Standards applied and documented evidence showing compliance missingInformation on design stages applied missing or incomplete, often refence to a procedureInformation on pre-clinical testing missing in TDs even though it had been performedPost market activities not clearly plannedTÜV SÜD Product Service GmbH MEDICAL DEVICE REGULATION Copyright - Do not distribute without preapprovalJanuary 202013
Get in contact with us Sign-up for Healthcare and Medical DevicesE-ssentials, TÜV SÜD’s complimentarynewsletter that delivers updates on the latestregulations and standards, at:www.tuv-sud.com/e-ssentialsDr. Bassil AkraVice PresidentStrategic Business DevelopmentGlobal Medical Health ServiceBassil.Akra@tuev-sued.dePhone: 49 89 5008 4421Fax: 49 89 5008 4403Contact us:www.tuv-sud.cominfo@tuv-sud.comFollow us on social tube.com/tuvsudgroupTÜV SÜD Product Service GmbH MEDICAL DEVICE REGULATION Copyright - Do not distribute without preapprovalJanuary 202014
Efficient communication between Legal Manufacturer,Economic Operators & Notified BodyMDR Support Panelsitem-inselJanuary 14th, 2020Arik Zuckersitem – insel MDR Support Panel1January 14th, 2020
MDR & NBs require a structured & readilysearchable Technical Documentationsitem – insel MDR Support Panel2January 14th, 2020
Several tools are used today forsubmission of Technical tpOwner ofTechDoceCTDGoogleDrive NotifiedBodyConformity Assessment sitem – insel MDR Support Panel3January 14th, 2020
Are these tools really suitable for yourfuture?MDR challenges & future requirements of LM Future business model Confidentiality requirements; in general & of supplier information Readily availability of TD upon request by CA / NB Trackability during conformity assessment & life cycle management / recertifications Broader use of same TD content for multiple purposes such as otherregulatory bodies, distributors, importers, etc.sitem – insel MDR Support Panel4January 14th, 2020
In fact, the Legal Manufacturer hasonly 2 optionsA. Maintain existing process by employing more regulatory staff if you can get them in the first place costlyB. Use an existing smarter tool that addresses the shortcomingsof the current processes / tools, for example MedtechVaultsitem – insel MDR Support Panel5January 14th, 2020
MedtechVault is a solution to efficientlyintegrate all Economic Operators & the NBNotified BodyLegalManufacturerOwner ofeTechDoc&driving relatedprocessesHighly secured documentvaultAuthorizedRepresentativeOBL / uppliersConsultants /AdvisorsMedtechVault is an add-on to your ERP system & QMSsitem – insel MDR Support Panel6January 14th, 2020
MedtechVault can support your MDRreadinessSuitable for MDR challenges & future requirements of LM Future business model Confidentiality requirements; in general & of supplier information Readily availability of TD upon request by CA / NB Trackability during conformity assessment & life cycle management / re certifications Broader use of same TD content for multiple purposes such as other regulatory bodies, distributors, importers, etc.sitem – insel MDR Support Panel7January 14th, 2020
For further enquiries, please contact:Arik Zucker, Partnerarik.zucker@mtvgr.com 41 79 786 69 19Armin Mäder, Partnerarmin.maeder@mtvgr.com 41 79 689 87 t.com 41 44 515 36 00METEVA Group AG Technoparkstrasse 1 CH – 8005 Zürich Switzerlandsitem – insel MDR Support Panel8January 14th, 2020
(1) Medical Device User Fee Cover Sheet (Form FDA 3601) (2) Center for Devices and Radiological Health (CDRH) Premarket Review Submission Cover Sheet (Form FDA 3514) (3) 510(k) Cover Letter (4) Indications for Use Statement (Form FDA 3881) (5) 510(k) Summary or 510(k) Statement (6) Trut
When carrying out a differential pressure adjustment on the pressure switch types MDR 1, MDR 11, MDR 2 and MDR 21 the cut-out pressure value changes and the cut-in pressure value remains constant. (Notice: As a standard, the MDR 1 / MDR 11 are delivered without a differential adjustment screw but aFile Size: 1MBPage Count: 11
When carrying out a differential pressure adjustment on the pressure switch types MDR 1, MDR 11, MDR 2 and MDR 21 the cut-out pressure value changes and the cut-in pressure value remains constant. (Notice: As a standard, the MDR 1 / MDR 11 are delivered without a differential adjustment
DIVISION: NORTH BENGAL CONSTRUCTION DIVISION, PWD Sl. No. Name of the Road Category Length (in km) 1 Bagdogra Trihana Road MDR 10.00 2 Bidhan Road MDR 1.00 3 Burdwan Road (Airview More to Naukaghat More) MDR 3.30 4 Hill Cart Road MDR 3.20 5 Kadma Panighata Road MDR 5.20 6 Kharibari Debiganj Road MDR 6.40
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
Skema 3 Eksempel: 1. Periode fra mdr. / år til mdr. / år 2. Antal år / mdr. 3. Klinikadresse / arbejdsadresse 4. Beskriv klientgrupper og problemstillinger 5. Beskriv dine arbejdsopgaver 6. Ca. antal konfront ationsti mer pr. uge. 01.01.1999-31.01.2002 3 år / 1 mdr. PPR A-Kom
Set up ingestion of AWS CloudTrail logs into Alert Logic MDR platform. Tag Amazon VPCs with Alert Logic identifiers in all AWS accounts so that they are included in the protection scope by Alert Logic MDR. Deploy Alert Logic MDR scanning and intrusion detection system (IDS) appliances to the target VPCs based on the protection scope.
Hush Panel 28 Hush Panel 32 Hush Panel 33 Hush Panel 37 Hush Panel 48 Hush Panel 52 Hush Ply 28 Hush Ply 32 When installing Hush Cem Panel 28 or Hush Cem Panel 32 the tongue and groove joints are to be glued using Hush Cem Panel Adhesive. All joints to be glued, on all sides of the panel to give the best bond. Adhesive not to be spared .
The API Standard 2000 5th Edition takes into account Tank Volume, Liquid Flow, and Temperature Change. It was written as a basis for the pressure control of hydrocarbons, and considered industrial tanks as well. It is this 5th Edition that is probably in widest use today. In 2009, this was updated to the API Standard 2000 6th Edition.
