European Medical Device Regulations (MDR): What To Expect
European Medical Device Regulations (MDR):What To ExpectMDQCMarch 2016Paul BrooksSenior Vice President Healthcare SolutionsCopyright 2015 BSI. All rights reserved.
Sources for MDR UpdateCommission Proposal for a Regulation ofthe European parliament andof the Council on medicaldevices, and amendingDirective 2001/83/EC,Regulation (EC) No 178/2002and Regulation (EC) No1223/2009 Parliament 2012/0266(COD) - 02/04/2014Text adopted by Parliament,1st reading/single reading EP adopted by 547 votes to19, 63 abstentions http://www.europarl.europa.eureference 2012/0266 CODCouncil Consolidated draft for EPSCO19 June 2015 - 400 pageswith many alterations andadditions Sept 2015 - Council’s full‘General Approach’ 040-2015-REV-1/en/pdf 040-2015-ADD1/en/pdfForeseeable outcome – best guess of todayCopyright 2015 BSI. All rights reserved.2
Trialogue Discussions – behind closed doorsEU CommissionEU ParliamentEU Council ofMinistersCopyright 2015 BSI. All rights reserved.3
MDR Timeline – Realistic Expectations:2016 Q1/Q22016 Q3/Q42016 Q42017 Q1 Trilogue concludes Agreement on MDR & IVDR EC Administration Translation into all EU languages EU MDR & IVDR Enter into force 3 year transition for MDR and 5 year transition for IVDRCopyright 2015 BSI. All rights reserved.17/03/20164
How to read 400 pages Copyright 2015 BSI. All rights reserved.5
Regulation No ?/2016/EU1.Check Definition of Medical Device(Article 2)2.Determine “Device Class”(Article 41, Annex VII)3.Select “Conformity Assessment Procedure” (Article 42)4.Identify Applicable “Essential Requirements” (Article 4, Annex I)5.Assemble “Technical Documentation”(Annex II)6.Apply Conformity Assessment Procedure(Annexes VIII, IX, X, XI)7.Complete “Declaration of Conformity”8.Affix “CE Mark”Copyright 2015 BSI. All rights reserved.(Article 17, Annex III)(Article 18, Annex IV)6
Proposed MDR Chapter IScope and DefinitionsCopyright 20122015 BSI. All rights reserved.17/03/20167
Headlines – Proposed MDR Chapter IScope and Definitions Expansion of regulations to cover: Clinical investigations in Europe Adverse incident/vigilance requirements Cosmetic products - after Common Speciation (CS) published – Annex XV Remanufacture of devices – single use devices Many new definitions Intended alignment with GHTF/IMDRFCopyright 2015 BSI. All rights reserved.8
Article 2 – Medical Device‘Medical device’ means any instrument, apparatus, appliance, software, implant,reagent, material or other article intended by the manufacturer to be used, aloneor in combination, for human beings for one or more of the specific medicalpurposes of: diagnosis, prevention, monitoring, treatment or alleviation of disease,diagnosis, monitoring, treatment, alleviation of or compensation for injuryor disability,investigation, replacement or modification of anatomy or of aphysiological or pathological process or state,providing information by means of in vitro examination of specimensderived from the human body, including organ blood and tissue donationsCopyright 2015 BSI. All rights reserved.Article 1 excludes IVD devicesfrom this Regulation9
Article 2 – Medical Deviceand which does not achieve its principal intended action by pharmacological,immunological or metabolic means, in or on the human body, but which may beassisted in its function by such means.Products specifically intended for the cleaning, disinfection or sterilisation ofmedical devices and devices for the purpose of control or support of conceptionshall be considered medical devices.Copyright 2015 BSI. All rights reserved.10
Article 1 – Scope – Annex XV – No Medical Purpose Contact lenses or other articles intended to be introduced into or onto the eye; Products intended to be totally or partially introduced into the human body through surgically invasivemeans for the purpose of modifying the anatomy or fixation of body parts with the exception of tattooingproducts and piercings; Substances, combinations of substances, or articles intended to be used for facial or other dermal ormucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction,excluding those for tattooing; Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment forliposuction, lipolysis or lipoplasty; High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipmentintended for use on the human body, including coherent and non-coherent sources, monochromatic andbroad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hairremoval or other skin treatment; Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagneticfields that penetrate the cranium to modify neuronal activity in the brain.Copyright 2015 BSI. All rights reserved.11
Safety & Performance RequirementsAnnex ICopyright 2015 BSI. All rights reserved.12
Annex I – Safety & Performance Requirements1.Safe, Perform as Intended, State of the Art2.Risk Reduction, Risk Management, Risk Control3.Lifetime4.Packaging5.Evaluated Benefits of achieved performance Known and Foreseeable Risks &Undesirable Side Effects6.Devices with no medical purpose – “shall not present any risk or only themaximum acceptable risks”6a. Machinery Directive – 2006/42/ECCopyright 2015 BSI. All rights reserved.13
Annex I – Safety & Performance Requirements7.Chemical, Physical & Biological Properties8.Infection & Microbial Contamination9.Devices incorporating a medicinal product and devices composed of substancesthat are absorbed by or locally dispersed in the human body10. Devices incorporating materials of biological origin11. Construction and environmental properties12. Devices with a diagnostic or measuring function13. Protection against radiationCopyright 2015 BSI. All rights reserved.14
Annex I – Safety & Performance Requirements14. Electronic programmable systems15. Active devices and devices connected to them16. Protection against mechanical and thermal risks17. Protection against the risks posed to the patient or user by suppliedenergy or substances18. Protection against the risks posed by medical devices intended by themanufacturer for use by lay persons19. Information Supplied by the Manufacturer Implant Card (Article 16) Promotional Material CE Marked (Article 18) UDI (Article 24)Copyright 2015 BSI. All rights reserved.15
Unique Device Identification – Article 24 COMMISSION RECOMMENDATION– 2013/172/EU on a commonframework for a unique deviceidentification system of medicaldevices in the Union. Work toward GHTF / IMDRF UDI FDA have completed specifications EN ISO 15223 – date format –YYYY/MM/DD*EU will probably allow GS1 & HIBCC*GS1 & HIBCC accepted by Turkey, Japan, India, USACopyright 2015 BSI. All rights reserved. Argentina, China, Canada, Brazil, Korea, Saudi Arabia16
Safety & Performance Requirements Check ListSafety & Performance Requirement #1Devices shall achieve the performance intendedby the manufacturer and be designed andmanufactured in such a way that, duringnormal conditions of use, they are suitable fortheir intended purpose.They shall be safe and effective and shall notcompromise the clinical condition or the safetyof patients, or the safety and health of users or,where applicable, other persons, provided thatany risks which may be associated with theiruse constitute acceptable risks when weighedagainst the benefits to the patient and arecompatible with a high level of protection ofhealth and safety, taking into account thegenerally acknowledged state of the art.ApplicableA/NADemonstration of ComplianceStandardsCSApplicable Harmonised Standards &Common SpecificationsA/NAFulfilledLocation of EvidenceTest ReportsLocationTechnical FileRecordLocationStandards & CS ConsideredReports/ JustificationHarmonised Standards – Article 6Common Specifications – Article 7Copyright 2015 BSI. All rights reserved.17
Proposed MDR Chapter IIEconomic Operators,Reprocessing, CE Marking, FreeMovementCopyright 20122015 BSI. All rights reserved.17/03/201618
Headlines – Proposed MDR Chapter IIEconomic Operators, Reprocessing, CE Marking, Free Movement Solution to keep healthcare institution in-house devices out of CE Marking Harmonized Standards and Common Specifications provide PoC Explicit requirements for manufacturers: Risk management system Post market clinical follow-up Comply with UDI requirements Quality management system Authorized representative – permanent access to technical documentation Importer and distributor requirements Person responsible for regulatory compliance Single-use devices and re-processing Information to supplied with implantable devicesCopyright 2015 BSI. All rights reserved.19
Industry Concerns*: Single-use Devices and Re-processing Reprocessing potentially permitted inconsistently by EU Member States Where permitted the framework is identified in MDR re-processor is re-manufacturer Fully responsible as manufacturer under CE Marking Hospitals can deviate from requirements for in-house reprocessing*“Industry Concerns” – not necessarily representative of BSI concerns/opinionsCopyright 2015 BSI. All rights reserved.17/03/201620
MDR Chapter IIIIdentification, Traceability, ClinicalSummary, EUDAMEDCopyright 20122015 BSI. All rights reserved.17/03/201621
Headlines – Proposed MDR Chapter IIIIdentification, Traceability, Clinical Summary, EUDAMEDTraceability of devices between economic operators and healthcare institutionsMedical device nomenclature – free of chargeUDI systemRegistration of economic operatorsSingle Registration Number (SRN) processSummary of safety and clinical performance (class III and implantable) – report validatedby NB uploaded Eudamed European databank Transparency of system Copyright 2015 BSI. All rights reserved.22
Proposed MDR Chapter IVNotified BodiesCopyright 20122015 BSI. All rights reserved.17/03/201623
Headlines – Proposed MDR Chapter IVNotified Bodies Prescriptive rewrite – stricter requirements Conflict of interest Competence Procedures Language Designation processCopyright 2015 BSI. All rights reserved.24
Joint Audits Under 920/2013 EC Voluntary assessments continuing; mandatoryassessments increasing in number Requirements still stepping up Notified Bodies merging stopping Suspended, de-designated scope reductions sales stop, specific regions stop, .Copyright 2015 BSI. All rights reserved.25
Proposed MDR Chapter VClassification and ConformityAssessmentCopyright 20122015 BSI. All rights reserved.17/03/201626
Headlines – Proposed MDR Chapter VClassification and Conformity Assessment Reclassifications – Class III: spinal, joints, AIMD, nano, some others Class IIa: reusable surgical instruments Scrutiny of clinical data for implantable class III devices Submission of NB and manufacturer evaluation (and PMCF) to EC expert panel (15days/60 days) Exceptions permitted:o For extensions to cleared CE marked devices and NB is satisfied no adverse impacton benefit/risk rationoro Where an common specification exists addressing clinical evaluation for type ofdeviceCopyright 2015 BSI. All rights reserved.17/03/201627
Classification & Conformity Assessment – MDDCompetent Authority AssessmentClass IIIClass IIbNotified Body Conformity AssessmentRiskClass IIaClass Im /IsSelf-CertificationClass ICustom MadeCopyright 2015 BSI. All rights reserved.28
Classification & Conformity Assessment – MDRClass III ImplantsCommission AssessmentClass IIICompetent Authority AssessmentClass IIb ImplantsClass IIbRiskClass IIa?Notified Body Conformity AssessmentClass IIaClass Im /IsSelf-CertificationCopyright 2015 BSI. All rights reserved.Custom MadeImplantsClass ICustom Made29
Changes to Rules:Rule 2 All non-invasive devices intended for channelling or storing blood, bodyliquids, cells or tissues, liquids or gases for the purpose of eventual infusion,administration or introduction into the body are in class IIa: if they may be connected to an active medical device in class IIa or ahigher class, if they are intended for use for storing or channelling blood or other bodyliquids or for storing organs, parts of organs or body cells and tissues,except for blood bags, which are in class IIb. In all other cases they are in class I.Copyright 2015 BSI. All rights reserved.30
Changes to Rules:Rule 3 All non-invasive devices intended for modifying the biological or chemicalcomposition of human tissues or cells, blood, other body liquids or otherliquids intended for implantation or administration into the body are in classIIb, unless the treatment consists of filtration, centrifugation or exchangesof gas, heat, in which case they are in class IIa. All non-invasive devices consisting of a substance or a mixture ofsubstances intended to be used in vitro in direct contact with human cells,tissues or organs taken off from the human body or with human embryosbefore their implantation or administration into the body are in class III.Copyright 2015 BSI. All rights reserved.31
Changes to Rules:Rule 5 All invasive devices with respect to body orifices, other than surgically invasive devices which arenot intended for connection to an active medical device or which are intended for connection to aclass I active medical device: are in class I if they are intended for transient use, are in class IIa if they are intended for short-term use, except if they are used in the oralcavity as far as the pharynx, in an ear canal up to the ear drum or in the a nasal cavity, inwhich case they are in class I, are in class IIb if they are intended for long-term use, except if they are used in the oral cavityas far as the pharynx, in an ear canal up to the ear drum or in a the nasal cavity and are notliable to be absorbed by the mucous membrane, in which case they are in class IIa. All invasive devices with respect to body orifices, other than surgically invasive devices, intendedfor connection to an active medical device in class IIa or a higher class, are in class IIa.Copyright 2015 BSI. All rights reserved.32
Changes to Rules:Rule 6 All surgically invasive devices intended for transient use are in class IIa unless they: are intended specifically to control, diagnose, monitor or correct a defect of the heart or of thecentral circulatory system through direct contact with these parts of the body, in which casethey are in class III, are reusable surgical instruments, in which case they are in class I, are intended specifically for use in direct contact with the heart or central circulatory system orthe central nervous system, in which case they are in class III, are intended to supply energy in the form of ionising radiation in which case they are in classIIb, have a biological effect or are wholly or mainly absorbed in which case they are in class IIb, are intended to administer medicinal products by means of a delivery system, if this is done ina manner that is potentially hazardous taking account of the mode of application, in whichcase they are in class IIb.Copyright 2015 BSI. All rights reserved.33
Changes to Rules:Rule 8 All implantable devices and long-term surgically invasive devices are in class IIb unless they: are intended to be placed in the teeth, in which case they are in class IIa, are intended to be used in direct contact with the heart, the central circulatory system or thecentral nervous system, in which case they are in class III, have a biological effect or are wholly or mainly absorbed, in which case they are in class III, are intended to undergo chemical change in the body, except if the devices are placed in theteeth, or to administer medicinal products, in which case they are in class III, are active implantable devices or their accessories, in which case they are in class III, are breast implants, in which case they are in class III, are total and partial joint replacements, in which case they are in class III, with the exceptionof ancillary components such as screws, wedges, plates and instruments, are spinal disc replacement implants and implantable devices that come into contact with thespinal column, in which case they are in class III with the exception of components such asscrews, wedges, plates and instruments.Copyright 2015 BSI. All rights reserved.34
Changes to Rules:Rule 9 All active therapeutic devices intended to administer or exchange energy are in class IIaunless their characteristics are such that they may administer or exchange energy to orfrom the human body in a potentially hazardous way, taking account of the nature, thedensity and site of application of the energy, in which case they are in class IIb. All active devices intended to control or monitor the performance of active therapeuticdevices in class IIb, or intended directly to influence the performance of such devices arein class IIb. All active devices intended to emit ionizing radiation for therapeutic purposes includingdevices which control or monitor such devices, or which directly influence theirperformance are in class IIb. All active devices that are intended for controlling, monitoring or directly influencing theperformance of active implantable devices are in class III.Copyright 2015 BSI. All rights reserved.35
Changes to Rules:Rule 17 All devices manufactured *incorporating or consisting of tissues or cells ofhuman or animal origin, or their derivatives, which are non-viable orrendered non-viable are in class III, unless such devices are manufacturedutilising tissues or cells of animal origin, or their derivatives, which are nonviable or rendered non-viable that are intended to come into contact withintact skin only.Copyright 2015 BSI. All rights reserved.36
New Rule #19: All devices incorporating or consisting of nanomaterial are in class III unlessthe nanomaterial is encapsulated or bound in such a manner that it cannotbe released into the patient’s or user's body when the device is used withinits intended purpose.Article 2 ‘nanomaterial’ means a natural, incidental or manufactured material containingparticles, in an unbound state or as an aggregate or as an agglomerate and where,for 50 % or more of the particles in the number size distribution, one or moreexternal dimensions is in the size range 1-100 nm; Fullerenes, graphene flakes and single-wall carbon nanotubes with one or moreexternal dimensions below 1 nm shall be considered as nanomaterials; ‘particle’ ‘agglomerate’ ‘aggregate’Copyright 2015 BSI. All rights reserved.37
New Rule #21: Devices that are composed of substances or combinations of substances thatare intended to be introduced into the human body via a body orifice, orapplied on skin and that are absorbed by or locally dispersed in the humanbody are: in class III if they, or their products of metabolism, are systemically absorbedby the human body in order to achieve the intended purpose, in class III if they are intended to be introduced into the gastrointestinal tractand they, or their products of metabolism, are systemically absorbed by thehuman body, in class IIb in all other cases, except if they are applied on skin, in which casethey are in class IIa.Copyright 2015 BSI. All rights reserved.38
New Rule #22: All invasive devices with respect to body orifices, other than surgically invasivedevices, which are intended to administer medicinal products by inhalation arein class IIa, unless their mode of action has an essential impact on the efficacyand safety of the administered medicinal product and those that are intendedto treat life threatening conditions, in which case they are in class IIb.Copyright 2015 BSI. All rights reserved.39
New Rule #23: Active therapeutic devices with an integrated or incorporated diagnosticfunction, which significantly determinates the patient management by thedevice are in class III, such as closed loop systems or automated externaldefibrillators.Copyright 2015 BSI. All rights reserved.40
Conformity AssessmentArticle 42Copyright 2015 BSI. All rights reserved.41
Custom Made DevicesAnnex XITechnical DocumentationAnnex XIIIPMS / PMCF / IncidentsName of Person Authorised to make out prescription, Name of Healthcare Institution& Name of Particular Patient Meets Requirements of Annex ICopyright 2015 BSI. All rights reserved.Article 42 Point 742
Class III Implantable – Custom Made DevicesAnnex XITechnical DocumentationAnnex VIIIAnnex X – Part AQMSProductionQuality AssuranceName of Person Authorised to make out prescription, Name of Healthcare Institution& Name of Particular Patient Meets Requirements of Annex ICopyright 2015 BSI. All rights reserved.Article 42 Point 7a43
Class I Device(non-sterile / no measuring function)Annex IITechnicalDocumentationDeclaration of Conformity (Annex III) & CE Marking (Annex IV)Copyright 2015 BSI. All rights reserved.Article 42 Point 544
Class I Device(sterile / measuring function)Annex IITechnicalDocumentation* Only aspects relatedto sterility / metrologyAnnex VIII*Annex X – Part A*QMSProductionQuality AssuranceDeclaration of Conformity (Annex III) & CE Marking (Annex IV)Copyright 2015 BSI. All rights reserved.Article 42 Point 545
Class IIa DeviceAnnex IIAnnex IITechnicalDocumentation *eachCategoryTechnicalDocumentationAnnex VIIIAnnex X – Part AAnnex X – Part BQMSProductionQuality AssuranceProductVerificationDeclaration of Conformity (Annex III) & CE Marking (Annex IV)Copyright 2015 BSI. All rights reserved.Article 42 Point 446
Class IIb DeviceAnnex IIAnnex IXTechnicalDocumentation *eachGeneric Device GroupType ExaminationAnnex VIIIAnnex X – Part AAnnex X – Part BQMSProductionQuality AssuranceProductVerificationDeclaration of Conformity (Annex III) & CE Marking (Annex IV)Copyright 2015 BSI. All rights reserved.Article 42 Point 347
Class IIb Implantable DeviceAnnex VIIIAnnex IXTechnicalDocumentation *eachGeneric Device GroupType ExaminationAnnex VIIIAnnex X – Part AAnnex X – Part BQMSProductionQuality AssuranceProductVerificationDeclaration of Conformity (Annex III) & CE Marking (Annex IV)Copyright 2015 BSI. All rights reserved.Article 42 Point 348
Class III Device(including those with medicinal substances, human tissues or animal tissues)Annex VIIIAnnex IXTechnicalDocumentationType ExaminationAnnex VIIIAnnex X – Part AAnnex X – Part BQMSProductionQuality AssuranceProductVerificationConsultation – 2001/83/EC, 2004/23/EC, 722/2012/EUDeclaration of Conformity (Annex III) & CE Marking (Annex IV)Copyright 2015 BSI. All rights reserved.Article 42 Point 249
Class III Implantable Device*(including those with medicinal substances, human tissues or animal tissues)Annex VIIIAnnex IXTechnicalDocumentationType ExaminationAnnex VIIIAnnex X – Part AAnnex X – Part BQMSProductionQuality AssuranceProductVerificationConsultation – 2001/83/EC, 2004/23/EC, 722/2012/EUConsultation Procedure – Annex VIII or Annex IX Section 6.0Declaration of Conformity (Annex III) & CE Marking (Annex IV)Copyright 2015 BSI. All rights reserved.Article 42 Point 250
Industry Concerns*: Scrutiny of clinical data for implantable class IIIdevices Potential delays, less predictable clearance of class III implantable devicesNo criteria for expert panel selectionDuplicative assessment following Notified Body assessmentDelays innovation and patient benefit*“Industry Concerns” – not necessarily representative of BSI concerns/opinionsCopyright 2015 BSI. All rights reserved.17/03/201651
Industry Concerns*: NB review of implantable class IIb devices Lead to significant review by NB’s of class IIb devices similar to class III’s Could be an oversight by Council If specific implantable devices need further NB scrutiny then up-classified to class III asjustified May overwhelm the NB system and be additional burden for SME’s*“Industry Concerns” – not necessarily representative of BSI concerns/opinionsCopyright 2015 BSI. All rights reserved.17/03/201652
Headlines – Proposed MDR Chapter VIClinical Evaluation, Clinical Investigation Manufacturer may request clinical strategy review from EC expert panelClinical data only from published peer reviewed dataClass III normally require clinical investigationClinical evaluation – class III and implantable devices can rely on equivalency data only: Manufacturers own proven equivalent devicesor Devices where manufacturer has contractual access to all data of equivalent devicesPCMF required – class III and implantable devices updated at least annually summaryreportClinical investigation documentation detailed preciselyEUDAMEDConsistent EU processesCopyright 2015 BSI. All rights reserved.53
Industry Concerns*: Clinical Evidence Clinical data excludes some sources of valid data – valid but unpublished: e.g. registries,patient feedback New equivalence approach may lead to unnecessary clinical investigations – expensive,unethical, not valid regulatory science perspective Clinician's may be unenthusiastic to conduct studies where data outcome is commonlyanticipated/expected*“Industry Concerns” – not necessarily representative of BSI concerns/opinionsCopyright 2015 BSI. All rights reserved.17/03/201654
Headlines – Proposed MDR Chapter VIIVigilance and Market Surveillance PMS suitable to analyze data on quality, performance and safety Update risk/benefit determination, clinical evaluation, summary of safety & clinicalperformance PMS plan required Periodic safety update report defined, including volume of sales, population of users, andfrequency of use – Class III and implantable updated annually and submitted to NB Vigilance in line with new MEDDEV Annual surveillance plans from authorities, including announced and unannounced facilityvisitsCopyright 2015 BSI. All rights reserved.17/03/201655
Technical DocumentationAnnex IICopyright 2015 BSI. All rights reserved.56
Technical Documentation – Annex II The technical documentation and, if applicable, the (STED) to be drawn up by the manufacturer shallinclude:1.2.3.4.5.6.DEVICE DESCRIPTION, SPECIFICATION, VARIANTS & ACCESSORIES Device description and specification Reference to previous / similar generations of the deviceINFORMATION SUPPLIED BY THE MANUFACTURERDESIGN AND MANUFACTURING INFORMATIONGENERAL SAFETY AND PERFORMANCE REQUIREMENTSRISK/BENEFIT ANALYSIS AND RISK MANAGEMENTPRODUCT VERIFICATION AND VALIDATION Pre-clinical and clinical data Additional information in specific casesCopyright 2015 BSI. All rights reserved.57
Clinical EvidenceInformation concerning the safety or performance that is generated from the use of a device andthat are sourced from the following:ClinicalInvestigation- DeviceconcernedClinicalInvestigationsreported inScientificLiteraturePeer reviewedScientificLiterature- Demonstratedequivalent devices- Demonstratedequivalent devices- Deviceconcerned Generated and verified from the manufacturer’s post-market surveillance system (PMCF).*Article 49 has some other words that only allow publications from the SAME manufacturerCopyright 2015 BSI. All rights reserved.58
QMSPMSArticle 60aVigilanceArticle 61-66Reactive PMSProactive PMSPost Market Clinical Follow-upAnnex XIIIApplies to every class of device under every route of conformity.Copyright 2015 BSI. All rights reserved.59
Declaration of ConformityAnnex IIICopyright 2015 BSI. All rights reserved.60
Declaration of Conformity – Annex III Name, Single Registration Number and address of themanufacturer; If applicable, name and address of the authorised representative; A statement that the declaration of conformity is issued under theresponsibility of the manufacturer; UDI – Article 24; Product and trade name, product code, catalogue number orother unambiguous reference, including intended purpose; Risk class of the device in accordance with Annex VII; A statement that the device is in conformity with this Regulationand, if applicable, with other relevant Union legislation that makeprovision for the issuing of a declaration of conformity; References to the relevant harmonised standards / commonspecifications used in relation to which conformity is declared; Where applicable, name and identification number of the notifiedbody, description of the conformity assessment procedureperformed and identification of the certificate(s) issued; Where applicable, additional information; Place and date of issue, name and function of the person whosigns as well as indication for and on behalf of whom he/shesigns, signature.Copyright 2015 BSI. All rights reserved.61
Certificates & CE MarkAnnex XII & Annex IVCopyright 2015 BSI. All rights reserved.62
Certificates Issued by a Notified Body – Annex XII: name, address and identification number of thenotified body; name and address of ONE manufacturer and, ifapplicable, of the authorised representative; unique number identifying the certificate; single registration number of the manufacturer date of issue; date of expiry; data needed for the unambiguous identification ofthe device(s) Product Specific – clear identification (name, model, type) ofdevice, intended purpose (same as in IFU), risk classification andUDI Quality System – identification of device or groups of devices,risk classification and for Class IIb the intended purpose if applicable, reference to a replaced previouscertificate;Copyright 2015 BSI. All rights reserved. reference to this Regulation and the relevant Annexaccording to which the conformity assessment hasbeen carried out; examinatio
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
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
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.
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 .
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
Acceptance testing for AngularJS is done via the Protractor tool, which is a framework developed by the team behind AngularJS. It is worth noting that Protractor uses by default Jasmine as the testing framework and it was not until recently that CucumberJS was integrated to Protractor. You should also be aware of the fact that CucumberJS does not cover all the features provided by the standard .
