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New European Medical Device Regulations – major changes that will affect all devices New European Medical Device Regulations – major changes that will affect all devices

New European Medical Device Regulations – major changes that will affect all devices - PowerPoint Presentation

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New European Medical Device Regulations – major changes that will affect all devices - PPT Presentation

Rene van de Zande EMERGO President amp CEO 1 512 327 9997 rvzemergogroupcom March 31 2016 New European Medical Device Legislation Two Drafts MDR 1204015 and IVDR 1204215 ID: 739899

devices notified unannounced medical notified devices medical unannounced market body device safety traceability bodies european ivds member require critical

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Slide1

New European Medical Device Regulations – major changes that will affect all devices

Rene van de ZandeEMERGO | President & CEO+1 512 327 9997rvz@emergogroup.comMarch 31, 2016Slide2

New European Medical Device Legislation – Two Drafts: MDR (12040/15) and IVDR (12042/15)

Trigger: PIP scandal in 2010 Post-market safety issues Weak oversight of Notified Bodies Lack of market surveillance by Competent Authorities Lack of transparency and traceability Access to external expertise Management of the EU regulatory systemSlide3

Important proposed changesGeneral management of medical devices in Europe (Medical Device Coordination Group)

Pre-market Approval?New or changed definitions – up-classification, non-medical devicesTraceability and registration of devicesCentral database for devices Introduction of UDIIntroduction of economic operatorsIntroduction of a Qualified PersonMore defined role of Notified Bodies (unannounced visits)Extra requirements for clinical evaluations / clinical investigationsPost-market surveillance and vigilance procedure much more detailedSlide4

Traceability of medical devices

Traceability, registration and publication of information concerning medical devices placed on the European marketCentral database for devices – EUDAMEDA summary of safety and clinical performance statement made publicly available for Class III and implantable devices (art. 26)A periodic safety report must be updated annually for every device or group of devices during the life time of the device (art. 60)Accessible by Competent Authorities, Notified Bodies…and by manufacturers, health care professionals, end users and the general public (?)“Appropriate” level of traceability - responsibilities for each in the supply chainSlide5

Unique Device

Identification - UDIEU COMM Recommendation 2013/172/EUDevice identifier placed on the label by manufacturerStored electronically by economic operators and health institutionsEU COM and member states shall operate the systemConsiderable International activity (IMDRF)United States currently ahead of EU Slide6

Qualified Person

Qualifications: expert knowledge in the field of in vitro diagnostic or medical devicesThree years of professional experience in regulatory affairs or in QMS relating to medical devices or IVD’s Responsible for ensuring: that the conformity of the devices is appropriately assessedTechnical documentation and the declaration of conformity are drawn up and kept up-to-date Vigilance requirements have been fulfilled Authorized representatives also required to have person responsible for regulatory complianceSlide7

European Authorized Representative

Article 9.(4a) provides that where the manufacturer is not based in an EU Member State, the authorized representative “shall be legally liable for defective devices…”Possibly in conflict with other European legislation including the Product Liability DirectiveArguments could be made that this could lower patient protectionSlide8

Already here…

Unannounced auditsMore attention by Notified Bodies into PMSFaster communication between competent authorities in case of vigilance cases or suspected non-compliancesMore pressure on Notified Bodies to take an active role in preventing non-compliant devices to be placed on the marketSlide9

EU COMM

Implementing Regulation (920/2013) designation supervision Notified BodiesExpect that over half of the current 70 NBs will not be re-notified or may not be notified for the same scopeSelection of NBs: Expertise and Competence, Size, Signed Code of Conduct, Which Member State notified the entity, AvailabilityIncreased scrutiny of and by Notified BodiesSlide10

EU COMM Recommendation for notified bodies’ unannounced visits (2013/473/EU

)Be ready for unannounced inspections…Unannounced Notified Body auditsSlide11

Minimum every 3 years (more frequently for high-risk)

Verify that manufacturing in line with documentationAudit at least two critical process:Design control, purchasing, incoming materials, assembling, sterilization, packaging product QCDesign Examination/Type Examination sample several products at end of line or warehouseTest in-house or in external labsSampling and test criteria determined in advanceIf impossible to take samples from market, where needed supported by competent authorityCompare with existing technical documentation, test protocols and results

Unannounced NB auditsSlide12

How to handle unannounced audits

SOP for unannounced notified body auditTrain staff about unannounced notified body auditsFamiliar with notified body contract and agreement about critical subcontractors and crucial suppliersKeep notified body informed on production scheduleReview contracts with critical subcontractors and crucial suppliersUnannounced audit of critical subcontractors and crucial suppliersSlide13

IVDRRisk-based

classification system for IVDs based on GHTF recommendationsGreater requirements on IVDs that are now self-certified Transition period of 5 years is currently considered, so manufacturers should have time to adjust to changesSlide14

New classification for IVDsSlide15

Majority

of IVDs will require NB interventionRequire notified bodyDo not require notified body80-90%Require notified

body

Do not require notified body

IVDD 98/79/EC

Future IVD RegulationSlide16

MDR and IVDR - timelines

October 2012 Commission proposal April 2014 Parliament proposalJune 2014 Commission positionJune 2015 Council general approachSeptember 2015 Council draft Next step: negotiation between Council and Parliament (and Commission) “trilogues”Currently, still in First ReadingDutch Minister of Health (January –June 2016), wants to have final version for second reading by June 2016 Slide17

Main impact of this future legislation

Innovative, high risk devices delayed market entry Cost increase industry (MDCG review, unannounced visits, traceability system review, UDI, implant card)Highly qualified staff required for manufacturer, notified body (and AR)NB assessment team: At least one expert in technologyDocumentation, review technical file, Summary of Safety and Clinical Performance, Essential Requirements text change for General Prescription for Safety and EfficiencySlide18

Finding and Evaluating Medical Device Distributors in Europe

Europe has a harmonized approval process but it is not a unified market for business Vastly different cultures, 24 primary languages28 member states - 19 use the EuroNorway, Iceland, Liechtenstein, and Switzerland members of the EEA500+ million people!Regulations should not stop you to market your devices in Europe!Don’t forget…Slide19

Questions?

Global Medical Device ConsultingVANCOUVER AREA15957 84th AveSuite 205

Surrey, BC, V4N 0W7

Canada

+1 604 909 1265

Daryl Wisdahl

Managing

Director, Canada

dw@emergogroup.com

TORONTO AREA

10 Four Seasons Place, Suite 1000

Toronto, ON, M9B 6H7

Canada

+1 888 254 3160

Rene van de Zande

President and CEO

rvz@emergogroup.com