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
Download Presentation The PPT/PDF document "New European Medical Device Regulations ..." is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.
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