MDR - Medical Device Regulation

3m ago
8 Views
0 Downloads
1.04 MB
44 Pages
Last View : Today
Last Download : n/a
Upload by : Gideon Hoey
Transcription

MDR Device Classification Conformity Assessment Safety & Performance Requirements Technical DocumentationSuzanne Halliday, D.Phil.Jaishankar Kutty, Ph.D.Ronald Rakos, Ph.DBSI Roadshow, October 20171

Agenda Classification rules – Annex VIII Conformity Assessment – Annex IX to Annex XI General Safety and Performance – Annex I Technical File Documentation – Annex II PMS and PMS Technical Documentation – Annex III2

MDR ClassificationAnnex VIII3

MDR - DefinitionsTermSurgically InvasiveDeviceInjured skin ormucous membraneActive deviceReusable surgicalinstrumentMDRan invasive device which penetrates inside the bodythrough the surface of the body, including throughmucous membranes of body orifices with the aid or inthe context of a surgical operation; (Annex VIII)means an area of skin or a mucous membranepresenting a pathological change or change followingdisease or a wound.Covered under Article 2‘active device’ means any device, the operation of whichdepends on a source of energy other than thatgenerated by the human body for that purpose, or bygravity, and which acts by changing the density of orconverting that energy. Devices intended to transmitenergy, substances or other elements between an activedevice and the patient, without any significant change,shall not be deemed to be active devices. Software shallalso be deemed to be an active device;Instrument intended for surgical use in cutting, drilling,sawing, scratching, scraping, clamping, retracting,clipping or similar procedures, without a connection toan active device and which is intended by themanufacturer to be reused after appropriate proceduressuch as cleaning, disinfection and sterilisation have beencarried out.MDDAn invasive device which penetrates inside the bodythrough the surface of the body, with the aid or inthe context of a surgical operation.n/aDeltaclarification that surgicallyinvasive also includespenetration throughmucous membranes ofbody orificesintroduced definition forinjured skin or mucousmembraneAny medical device operation of which depends on asource of electrical energy or any source of powerother than that directly generated by the humanbody or gravity and which acts by converting thisenergy. Medical devices intended to transmit energy,substances or other elements between an activemedical device and the patient, without anysignificant change, are not considered to be activemedical devices. Stand alone software is consideredto be an active medical device.Device which acts bychanging the density ofenergy are also consideredactive devices. This isconsidered a clarificationonlyInstrument intended for surgical use by cutting,drilling, sawing, scratching, scraping, clamping,retracting, clipping or similar procedures, withoutconnection to any active medical device and whichcan be reused after appropriate procedures havebeen carried out.devices which can be reused vs intended by themanufacturer to be reused;mostly a clarification4

MDR – Definitions & Implementing RulesTermContinuous useDirect diagnosisImplantable deviceMDRMDDDeltaconcept of continuous use(a) the entire duration of use of the same deviceextended to includewithout regard to temporary interruption of use during ameans ‘an uninterrupted actual use of the device for devices that may beprocedure or temporary removal for purposes such asthe intended purpose’.temporarily removed to becleaning or disinfection of the device. Whether theHowever where usage of a device is discontinued in cleaned or disinfected andinterruption of use or the removal is temporary shall beorder for the device to be replaced immediately bythen re-used; However thisestablished in relation to the duration of the use prior tothe same or an identical device this shall beis still considered aand after the period when the use is interrupted or theconsidered an extension of the continuous use of the clarification since such usedevice removed; and (b) the accumulated use of adevicewould be treated asdevice that is intended by the manufacturer to be'continuous use' under thereplaced immediately with another of the same type.Directive as wellA device is considered to allow direct diagnosis when itprovides the diagnosis of the disease or condition inquestion by itself or when it provides decisiveinformation for the diagnosis.n/anew definitionAny device which is intended:— to be totally introduced into the human body or,— to replace an epithelial surface or the surface ofthe eye, by surgical intervention which is intended toremain in place after the procedure.Any device intended to be partially introduced intothe human body through surgical intervention andintended to remain in place after the procedure forat least 30 days is also considered an implantabledevice.Devices that are partially orwholly absorbed areconsidered implantable;'Clinical' intervention vs'surgical' interventionCovered under Article 2.5‘implantable device’ means any device, including thosethat are partially or wholly absorbed, which is intended:— to be totally introduced into the human body, or — toreplace an epithelial surface or the surface of the eye,by clinical intervention and which is intended to remainin place after the procedure.Any device intended to be partially introduced into thehuman body by clinical intervention and intended toremain in place after the procedure for at least 30 daysshall also be deemed to be an implantable device;5

Classification Rules – MDR, Annex VIIIMDRMDDRules 1 – 4: Non-invasive devicesRules 1 – 4 : Non-invasive devicesRules 5 – 8 : Invasive devicesRules 5 – 8 : Invasive devicesRules 9 – 13 : Active DevicesRules 9 – 12 : Active devicesRules 14 – 22 : Special rulesRules 13 – 18 : Special rules6

Rules 1 - 4: Non-invasive devices (in comparison with MDD)Rule 1Rule 2Rule 3Rule 4 No change Addition of “cellsand tissues” to theexisting language Addition of humantissues and cells toblood, body liquidsand other liquids Addition of injuredmucousmembrane toinjured skin Intended forimplantation oradministration vsIntended forinfusion in MDD Replacement of‘wounds’ withinjuries to skin Blood bags movedto MDR Rule 2from Rule 18 ofMDD Inclusion of organstorage solutions,IVF media into therule which areclass III Also coversinvasive devicesthat come intocontact withinjured mucousmembrane7

Rules 5 – 8: Invasive devices (in comparison with MDD/AIMD)Rule 5Rule 6Rule 7Rule 8 No change –clarifications only All devicesintendedspecifically fordirect contact withheart or centralcirculatory systemnow class IIIsimilar to devicesin contact withcentral nervoussystem All devicesintendedspecifically fordirect contact withheart or centralcirculatory systemnow class IIIsimilar to devicesin contact withcentral nervoussystem AIMD devices andaccessories are classIII Breast implants andsurgical meshes areclass III Total and partialjoint replacementsare class III Spinal discreplacementimplants orimplantable devicesthat come intocontact with spinalcolumn are class IIIwith someexceptions (screws,wedges, plates andinstruments)8

Rules 9 – 13: Active Devices (in comparison with MDD/AIMD)Rule 9 Addition of activedevices intended toemit ionizing radiationfor therapeuticpurposes, includingdevices which controlor monitor suchdevices, or whichdirectly influence theirperformance, areclassified as class IIb. Addition of activedevices that areintended forcontrolling, monitoringor directly influencingthe performance ofactive implantabledevices are classifiedas class III.Rule 10 Addition of‘monitoring’ todiagnosis; Active devicesintended fordiagnosis inclinical situationswhere the patientis in immediatedanger as classIIbRule 11 New rule onsoftwareRule 12 Rule 11 in MDD No change Classificationsrange from classIII – class IRule 13 Rule 12 in MDD No change9

Rules 14 – 18: Special rulesRule 14Rule 15Rule 16Rule 17Rule 18(Devices withmedicinalsubstances)(Contraceptivedevices, Devicesfor prevention oftransmission ofSTDs)(Disinfectants,sterilizers)(Devices forrecording x-raydiagnostic images)(Devices utilizinghuman or animalderivatives) Rule 13 in MDD Rule 14 in MDD Rule 15 in MDD Rule 16 in MDD Rule 17 in MDD Clarification thatmedicinal productcan be derivedfrom human bloodor plasma No change Addition ofsterilisers todisinfectants No change –language clarified “Liable to act”taken out Disinfectants orsterilisers becomeIIb only if theyare used forinvasive devicesand as the endpoint ofprocessing Addition of cells (totissues) Addition of humanorigin cells and tissuesor derivatives The exception aboutcontact with intactskin only, applies onlyto animal tissue anddoes not apply tohuman tissues or cells10

Rules 19 – 22: Special rulesRule 19Rule 20Rule 21Rule 22(Devices incorporatingor consisting ofnanomaterials)(Body-orifice invasivedevices intended toadminister medicines byinhalation)(Devices consisting ofsubstances andintroduced into thebody via body orifice orskin and that areabsorbed by or locallydispersed)(Active therapeuticdevice with anintegrated orincorporated diagnosticfunction) New rule New rule New rule New rule Classifications from IIIto IIa based on potentialfor internal exposure Classification IIa or IIb Classification from IIa toIII based on where theyare used and whetherthey or their products ofmetabolism areabsorbed Class III IIb if they impact thesafety and performanceof the medicine orintended to treat lifethreatening conditions Only applies if suchdevices significantlydetermine the patientmanagement Closed loop systems orautomated externaldefibrillators11

Conformity Assessment ProceduresAnnex IX, X, XI12

Classification & Conformity Assessment – MDDClass IIICompetent Authority AssessmentClass IIbNotified Body Conformity AssessmentRiskClass IIaClass Im /IsSelf-CertificationClass ICustom Made1313

Classification & Conformity Assessment – MDRCommission AssessmentClass III ImplantsClass IIb active – administermedicineClass IIIClass IIb ImplantsCompetent Authority AssessmentClass IIbRiskNotified Body Conformity AssessmentClass IIaClass Im /IsClass III Custom MadeImplantsClass IrSelf-CertificationClass ICustom Made1414

15 5 years 5 yearsClass III Class IIb Active intended to administer and/or removemedicines from the body Class IIb Implants Sutures, staples, dental fillings, dental braces, toothcrowns, screws, wedges, plates, wires, pins clips connectors Class IIb Class IIa sample 5 yearsper group sample SSCP (Article 32) PSUR (Article 86)(*Annual)Clinical EvaluationConsultationProcedure (CECP)(Article 54) 2001/83/ECEC/726/20042004/23/ECEU 722/2012Unannounced Audit TechnicalDocumentationClass III ion EU 2017/745 – Conformity Assessment * * * notsubmitted to NB 5 years * 5 years 5 years * notsubmitted to NB 5 years notsubmitted to NBper group sampleper group sampleper category15

16SSCP (Article32)PSUR CEU CP) icrobiologyQualityManagementSystemRegulation EU 2017/745 – Conformity AssessmentClass IClass Is, Im, Ir Class III Custom Made Implants 5 years 5 years * notsubmitted to NBCustom MadeProcedure Packs (Article 22)Suppliers, Subcontractors *depends oncertification held 5 yearsEU Authorised Representatives,Importers, Distributors (Article 16) *impact sterile *impact sterile 5 yearsbarrier, translate,repackage*depends oncertification heldbarrier, translate,repackage16

General Safety & PerformanceRequirementsAnnex I17

General Safety & Performance Requirements (Annex I)MDD 93/42/EEC: 13 Essential requirementsAIMDD 90/385/EEC: 16 Essential requirementsMDR 2017/745:23 General Safety &PerformanceRequirements Similar to “Essential Requirements” in Directives.̵Similar content and topics̵Some numbering and organizational changes̵Expanded requirements (Labeling, Risk)̵New areas of emphasis (from standards and guidances, etc.)̵Some additional requirements because of merging of MDD with AIMDD̵Some topics move out of the SPR list into Articles/Annexes (Clinical, medicinalconsultation)̵Some new topics introduced (devices without medical purpose, lay person use, etc.)Copyright 2017 BSI. All rights reserved.18

Annex I: Safety and Performance RequirementsChapter 1:GeneralRequirements(SPRs 1-9)Chapter 2:Design andManufacture(SPRs 10-22)Chapter 3:InformationSupplied withthe Device(SPR 23)19Copyright 2017 BSI. All rights reserved.

Annex I: Safety and Performance RequirementsChapter 1:GeneralRequirements(SPRs 1-9) Copyright 2017 BSI. All rights reserved. Chapter 2:Design andManufacture(SPRs 10-22)1:Similar to ER 1 with additional emphasis onrisk/benefit and “state-of-the-art”2-5: Much greater emphasis on risk management9: New requirement for devices without a medicalpurposeRemainder similar to DirectiveChapter 3:InformationSupplied withthe Device(SPR 23)20

Annex I: Safety and Performance Requirements10: Much more detail regardingchemical, physical and biologicalproperties, toxicology. and specificsubstances of concern.Chapter 1:General11: More requirements forRequirementsinfection and microbialcontamination(SPRs 1-9)12: Medicinal substancesscope expanded to includesubstances that are absorbedby or locally dispersed in thehuman bodyCopyright 2017 BSI. All rights reserved.22: New requirement:Devices for lay person usersChapter 2:Design andManufacture(SPRs 10-22) 13: Biological tissues expandedto include human tissues (nonviable) Also includes catch-all fornon-viable biological substancesof neither human nor animalorigin20: Much more detail onmechanical and thermal risksMitigate risks of fitting/refittingparts by design16-18: Active and AIMD, manyChapter3: some new:similaror identical, InformationIncreased emphasis on cybersecurity withSupplied theMoreDeviceemphasis on ionisingradiation/”electromagnetic(SPR 23)interference” Requirements from ISO 6060114: More requirements forinteraction with theenvironment and compatibilitywith other devices, includingergonomics, calibration,disposal21

Annex I: Safety and Performance Requirements Many clarifications on labelling requirements. 23.2: Additional requirements for UDI, devicesincorporating human or animal tissues, medicines,absorbable devices, “is it a MD” & others 23.3: Specific requirements for labelling on sterilepackagingChapter 1:Chapter 2: Indication if carcinogenic/mutagenic/toxic (CMR)Design andsubstances GeneralRequirements(SPRs 1-9)Manufacture(SPRs 10-22)23.4: Many new IFU requirements and cross-referencing toarticles, including (among others): Installation verification, PM, calibration, identification ofconsumable components and how to replace (23.4k) Many more specific warning requirements (EMC, medicinalsubstances, human or animal tissues, CMR and endocrinedisruptors) (23.4s) Absorbable/dispersible materials (23.4t) Information on materials for implants (23.4u) Information security measures (23.4ab)23.1: More “general” requirements (e.g.format, readability, “understood”, availability,eIFU, lay person etc.), “residual risks”Chapter 3:InformationSupplied withthe Device(SPR 23)Labeling requirements have changedand expanded significantly22Copyright 2017 BSI. All rights reserved.

Technical DocumentationAnnex IIBSI Confidential, Copyright 2017 BSI. All rights reserved23

Annex IITechnical Documentation“The technical documentation and, if applicable, the summary thereof to be drawnup by the manufacturer shall be presented in a clear, organised, readilysearchable and unambiguous manner .”Key Change: The MDR is very prescriptive regarding the Technical Documentation contentand formatting.BSI Confidential, Copyright 2017 BSI. All rights reserved24

Annex IITechnical DocumentationTechnical Documentation requirements are subdivided into the following 6 sections:1.Device description and specification, including variants and accessories2.Information to be supplied by the manufacturer3.Design and manufacturing information4.General safety and performance requirements5.Benefit-risk analysis and risk management6.Product verification and validationBSI Confidential, Copyright 2017 BSI. All rights reserved25

Annex II1. Device description and specification, including variants and accessories Product name, description, intended purpose, intended users Basic UDI-DI or other unambiguous reference (product code, catalogue number etc.) Intended population, indications, contraindications, warnings Principle of operation of the device and mode of action; scientifically demonstrated Rationale for considering the product a medical device Device classification, applicable rules & rationale Explanation of any novel features Description of accessories provided with or without the device Description of all the relevant variants of the device sizes, shapes, material thicknesses, etc. Device pictures, relevant drawings Description of all the relevant raw materials along with a risk assessment from biological safety perspective Technical specifications, dimensions & performance attributes Reference & overview of previous and similar generations of the subject device and device market history Discussion of medicinal therapies used in conjunction with procedureBSI Confidential, Copyright 2017 BSI. All rights reserved26

Annex II2. Information to be supplied by the manufacturer (SPR 23)A complete set of: the label or labels on the device and on its packaging and the instructions for use in the languages accepted in theMember States where the device is to be sold Promotional materials (Article 20) Implant Card (Article 18, SPR 23.4 aa) Summary of safety and clinical performance (SSCP, Article 32)Annex II3. Design and manufacturing information Information to allow the design stages applied to the device to be understood Complete information and specifications, including the manufacturing processes and their validation, their adjuvants, thecontinuous monitoring and the final product testing. Data shall be fully included in the technical documentationNote: ISO 13485:2016 requires design validation to be conducted on representative product (e.g., sterile finished devices). Identification of all sites including suppliers and subcontractors; where design and manufacturing activities are performedBSI Confidential, Copyright 2017 BSI. All rights reserved27

Annex II4. General safety and performance requirements Documentation shall contain information to demonstrate conformity to general safety and performancerequirements (GSPR or SPRs) that are applicable (Annex I) taking into account its intended purpose andshall include methods used to demonstrate conformity (justification, validation and verification). DemonstrationofApplicabilityconformation shall include:SPRStandard or CS X YZDemonstration/testingGSPRs that apply explanation of why any GSPR does not apply;(justification,validation andMethod(s) used to demonstrate conformity verification)Harmonised standards, CS or other solutions applied andLocation(Precise identity)The precise identity of the controlled documents offering evidence of conformity HarmonisedStandard, CS or method(s) [including] a cross-reference to the location of such evidence withinthe full technical documentation Have to clearly show/demonstrate how each SPR is met/satisfied.BSI Confidential, Copyright 2017 BSI. All rights reserved28

Annex II5. Benefit-risk analysis and risk managementThe documentation shall contain information on: The benefit-risk analysis (Annex I, Section 1 and 8) The solutions adopted and the results of the risk management referred to in Section 3 of Annex I (SPR 3)SPR 3 is essentially a summary of the requirements of EN ISO 14971:2012BSI Confidential, Copyright 2017 BSI. All rights reserved29

Annex II6. Product verification and validationThe documentation shall contain the results and critical analyses of all verifications and validation tests and/or studies undertaken todemonstrate conformity with the requirements of the MDR and in particular the applicable SPRsPre-Clinical and Clinical data In Vitro & In Vivo test outcomes, simulated use testing, evaluation of the published literature and overall discussion of preclinical Detailed discussion of test design, test protocols and reports with data analysis and conclusions in particular for the following:safety in combination with conformance with specifications biocompatibility (Annex I, SPR 10) physical, chemical and microbiological characterization (Annex I, SPR 10 and 11) electrical safety and electromagnetic compatibility (Annex I, SPR 18, AIMD: SPR 19) software verification and validation (Annex I, SPR 17) stability, including shelf life (Annex I, SPR 7) performance and safety (Annex I, SPR 1 and 6)Where applicable conformity to Directive 2004/10/EC (GLP Directive) must be demonstrated (for devices containing medicinalsubstances)Where no new testing has been conducted the documentation shall incorporate a rationale for that decision Very prescriptive requirements with links to SPRs and CER; evaluation of the published literature with respect to pre-clinical testing Clinical evaluation plan and report (along with updates) per Article 61(12) [CER] and Part A of Annex XIV (detaileddescription of CER)BSI Confidential, Copyright 2017 BSI. All rights reserved30

Annex II6. Product verification and validationAdditional information for specific cases: Medicinal substances requirements per Directive 2001/83/EC (Annex I, SPR 12) Requirements for devices utilizing tissues or cells of human or animal origin or their derivatives (Annex I, SPR 13) Devices composed of substances or combinations thereof intended to be introduced into the human body that are absorbedby or locally dispersed (Annex I, SPR 12) Carcinogenic, mutagenic or toxic to reproduction (CMR) and endocrine-disrupting substances (Annex I, SPR 10.4) Sterility and microbiological condition (Annex I, SPR 11) Measuring Function (Annex I, SPR 15) Devices connected to other devices, description and compliance with SPR (Annex I, SPR 14)BSI Confidential, Copyright 2017 BSI. All rights reserved31

Technical Documentation onPost-Market SurveillanceAnnex IIIand overview of MDR PMS requirementsBSI Confidential, Copyright 2017 BSI. All rights reserved32

Article 2, Definition 61‘Post-Market Surveillance’all activities carried out by themanufacturer in cooperation with othereconomic operators to institute and keepup to date a systematic procedure toproactively collect and review experiencegained from their devices placed on themarket, made available on the market orput into service for the purpose ofidentifying any need to immediately applyQMSCurrent MDD RequirementsPMSVigilanceReactive PMSProactive PMSPMCFany necessary corrective or preventiveactions;BSI Confidential, Copyright 2017 BSI. All rights reserved33

Post Market Surveillance (PMS)Specific Requirements in the MDR1.PMS system of the manufacturer (Article 83)2.PMS plan (Article 84)3.PMS report (Article 85)4.Post Market clinical follow-up (PMCF) report (Article 61, 11 and Annex XIV, Part B) For Class III devices and implantables devices the PMCF evaluation report and if indicated theSummary of Safety and Clinical Performance (SSCP, Article 32) shall be updated at leastannually5.Periodic safety update report (PSUR, Article 86)6.Summary of Safety and Clinical Performance (SSCP, Article 32)BSI Confidential, Copyright 2017 BSI. All rights reserved34

Chapter VII: PMS, vigilance and market surveillanceArticle 83 – PMS system of the manufacturer For each device, manufacturers shall plan, establish, document, implement,maintain and update a PMS system in a manner that is proportionate to the riskclass and appropriate for the type of device. The PMS plan shall be an integral part of the manufacturer’s QMS referred to inArticle 10(9). The PMS system shall be suited to actively andsystematically gathering, recording and analysingrelevant data on the quality, performance and safetyof a device throughout its entire lifetime, and todrawing the necessary conclusions and todetermining, implementing and monitoring anypreventive and corrective actions.35

PMS system of the manufacturer shall be used for (Article 83):DeviceLifetimeQMSPMS36

PMS – Article 83, 87 If, in the course of the post-market surveillance, aneed for preventive or corrective action or both isidentified, the manufacturer shall implement theappropriate measures and inform the competentauthorities concerned and, where applicable, thenotified body.‘serious incident’ means any incident that directly or indirectlyled, might have led or might lead to any of the following:a) the death of a patient, user or other person,b) the temporary or permanent serious impairment of thepatient's, user's or other person's state of health,c) a serious public health threat; Where a serious incident is identified or a fieldsafety corrective action is implemented, it shall‘field safety corrective action’ means corrective actiontaken by a manufacturer for technical or medicalreasons to prevent or reduce the risk of a seriousincident in relation to a device made available on themarket;be reported in accordance with Article 87.37

PMS – Article 84, 85, 86Article 84 – PMS plan The post-market surveillance systemreferred to in Article 83 shall bebased on a post-market surveillanceArticle 85 – PMS Report Manufacturers of Class I devices Summary of results and conclusionsfrom analysis of PMS data gatheredplan, the requirements for which areas according to PMS planset out in Section 1.1 of Annex III. For devices other than custom-made any preventive and corrective actiondevices, the post-market surveillancetakenplan shall be part of the technicaldocumentation specified in Annex II.Include description and rationale forArticle 86 - PSURManufacturers of class IIa, IIb and IIIdevices shall prepare a PSUR for eachdevice and for each category/group ofdevices summarizing the PMS data perthe PMS plan (Article 83).Throughout the lifetime of the device,the PSUR shall include: Conclusions of benefit-riskdetermination;Made available to NB and CA on Main findings of PMCFrequest Sales volume, estimate of size andcharacteristics of population andfrequency of usage Updated when necessary 38

Annex III – Technical Documentation on PMSThe technical documentation on post-market surveillance to be drawn up by the manufacturer in accordance with Articles83 to 86 shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include inparticular the elements described in this Annex.1.1 a: The post-market surveillance plan shall address the collection and utilization of available information, in particular:information concerning seriousincidents, including informationfrom PSURs, and field safetycorrective actionsrelevant specialist or technicalliterature, databases and/orregistersrecords referring to non-seriousincidents and data on anyundesirable side effectsinformation, including feedbacksand complaints, provided by users,distributors and importersinformation from trend reporting(Article 88)publicly available informationabout similar medical devices39

Annex III1.1 b: PMS planShall cover at least: proactive and systematic process to collect the information referred to in previous slide (EN ISO 13485:2016, 8.2.1) Comparison between device and similar products on the marketeffective methods to assess the collected data (including complaints, market-related experience, trend reporting,recognise significant data) suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit-risk analysisand risk management (Annex I, SPR 3) complaint investigation and analysis (EN ISO 13485:2016, 8.2.2) methods/protocols to manage events subject to the trend reporting regarding any statistically significate increase in thefrequency or severity of incidents (Article 88)BSI Confidential, Copyright 2017 BSI. All rights reserved40

Annex III1.1 b: PMS planShall cover at least: methods to communicate effectively with NB, CA, economic operators and users (EN ISO 13485:2016, 8.2.3) reference to procedures to fulfil the manufacturers obligations (PMS) procedures to identify and initiate appropriate corrective measures/corrective actions effective tools to trace and identify affected devices PMCF plan (Annex XIV, Part B) or justification as to why one is not applicable1.2The PSUR referred to in Article 86 and the post-market surveillance report referred to in Article 85.BSI Confidential, Copyright 2017 BSI. All rights reserved41

PMS in the MDRQMSPMSArticle 83MDR RequirementsPSURArticle 86VigilanceArticle 87-90Reactive PMSProactive PMSPMCFAnnex XIVBSI Confidential, Copyright 2017 BSI. All rights reservedSSCPArticle 3242

Conclusion Classification rules – Annex VIIIAdded clarifications & new rules Conformity Assessment – Annex IX to Annex XICECP - Class III implantable, certain Class IIb General Safety and Performance – Annex IIncreased from 13 to 23 Technical File Documentation – Annex IIPrescriptive requirements PMS and PMS Technical Documentation – Annex III More specifics around PMS requirements43

Where can I find full details of the -revisionWebinars: bsigroup.com/webinarsWhitepapers: bsigroup.com/whitepapersPlease ask if you want any extrainformation from BSI.Copyright 2017 BSI. All rights reserved.44

Classification Rules -MDR, Annex VIII MDR MDD Rules 1 -4: Non-invasive devices Rules 5 -8 : Invasive devices Rules 9 -13 : Active Devices Rules 14 -22 : Special rules Rules 1 -4 : Non-invasive devices Rules 5 -8 : Invasive devices Rules 9 -12 : Active devices Rules 13 -18 : Special rules

Related Documents:

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

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

definition of the Medical Device. If it matches, then the software is called MDSW. Chapter 3 Explains also Classification. Classification determines the risk class of the Medical Device. The higher the risk class the stricter the MDR requirements are. Classification is comparing the intended use of the Medical Device with the classification .

The European Medical Devices Regulation 2017/745 (MDR) includes general safety and performance requirements (GSPRs) in Annex I related to infection and microbial contamination. These GPSRs include requirements related to sterility. The In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) includes parallel requirements to the MDR.

and Zimbabwe (4.6/14%) also listed among the 30 high MDR-TB burden countries in the world [1]. Although MDR-TB is a growing concern in Africa where limited resource exists, it is largely under-reported [18, 19]. In Ethiopia, many of the MDR-TB patients are remain undiag-nosed due to the low socioeconomic status of the popula-

20W Single Output Industrial DIN Rail Power Supply . MDR-20 . series. Model: MDR-20-24 Test Report 3 / 5 . ENVIRONMENT TEST NO TEST ITEM SPECICATION TEST CONDITION RESULT VERDICT . 1 . TEMPERATURE RISE TEST MODEL:MDR-20-24 1. ROOM AMBIENT BURN-IN:1.5HRS I/P: 230VAC O/P: FULL LOAD Ta 31.4 .

PAGE 8 — MQ-MIKASA MDR-9D VIBRATORY ROLLER — OPERATION AND PARTS MANUAL — REV. #0 (12/17/03) MDR-9D — RULES FOR SAFE OPERATION ALWAYS refuel in a well-ventilated area, away from sparks and open flames. ALWAYS use extreme caution when working with flammable liquids. When refueling, stop the engine and allow it to cool.

www.condor-cpc.com 27 Pressure diagrams Mdr 1 Cable glands Mdr 1 Pressure switch Mdr 1 Wn PG 11 G PG 11 Z PG 11 ZK Explanation devices with differential pressure adjustment An intersecting point is determined in the diagram by selecting a pair of cut-in and cut-out pressure values. If

MEDDEV 2.7.1 rev. 4 on the clinical evaluation is partly inspired by the Medical device Regulation (MDR), it remains insufficient to presume compliance with the requirements of the MDR. Additionnally, the other MEDDEV specific to the vigilance sys-tem and PMCF studies1 are old (2012 and 2013) and even if

single-use medical devices (Article 17) 3; and certain devices with no intended medical purpose (Annex XVI). The MDR also covers internet sales of medical devices and med - ical devices used for diagnostic or therapeutic services offered at a distance (Article 6). The MDR introduces a

All medical devices and IVDs put into service, must have MDR/IVDR certificates. Nothing certified under the old system can be used for the first . ISO/IEC 15416:2000 – Information Technology –Automatic identification and data capture techniques - Bar c

DIR-330 A1 Device 6-18-2016 DIR-130 A1 Device 6-18-2016. DFE-690TXD A4 Device 6-8-2016 DFE-538TX F2 Device 6-8-2016 DFE-528TX E2 Device 6-8-2016 DXS-3250E A1 Device 5-31-2016 DXS-3250 A1 Device 5-31-2016 DXS-3227P A1 Device 5-31-2016 DXS-3227 A1 Device 5-31-2016 DEM-411T A1 Device 5-31-2016

MEDDEV 2 12-1 rev. 8 Vigilance 6 d) devices that do not carry the CE-mark but where such INCIDENTs lead to CORRECTIVE ACTION(s) relevant to the devices mentioned in a), b) and c). These guidelines cover FIELD SAFETY CORRECTIVE ACTION relevant to CE-marked devices which are offered for sale or are in use within the EEA, Switzerland and Turkey. .File Size: 663KBPage Count: 64Explore further(PDF) MEDDEV 2.12-1 Rev.6 Medical devices vigilance system .www.academia.eduMEDDEV Guidance List - Download - Medical Device Regulationwww.medical-device-regulation.euMEDDEV 2.12/1 rev. 8 Vigilance System (2013) - CEpartner4Uwww.cepartner4u.comMEDDEV 2.12-1 rev. 8 Vigilance system (2019 - Additional .www.cepartner4u.comEU MDR Vigilance Reporting and MEDDEV 2.12-1 Rev 8www.orielstat.comRecommended to you b

medical devices and combination products. The European Union Medical Device Regulation (EU MDR) and ISO 14971:2019 requirements are bringing the full burden of risk management to medical devices and combination products. Risk management in the new era is a big undertaking. It spans all lifecycles of product development and

who medical device technical series: to ensure improved access, quality and use of medical devices who medical device technical series human resources for medical devices the role of biomedical engineers development of medical device policies, strategies and action plans who medical device technical series

the new regulations will officially be applied (see Fig. 1). Given their broadened scope and increased complexity, the new MDR regulations pose a significant compliance challenge to medical device companies. Among the most complex are: focus on life cycle management more extensive requirements for

and new obligations span every aspect of the medical device lifecycle, from development and clinical evaluation to market access, surveillance and vigilance. Indeed, economic operators and health institutions in Europe are expected to comply with the applicable requirements of the MDR by the application date of May 26, 2020.

« On attend par additif alimentaire : toute substance habituellement non consommée comme aliment en soi et habituellement non utilisée comme ingrédient caractéristique dans l’alimentation, possédant ou non une valeur nutritive, et dont l’adjonction intentionnelle aux denrées alimentaires, dans un but technologique au stade de leur fabrication, transformation, préparation .