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Medical Devices Regulation in the European Union Albuquerque - 10 April 2012

Medical Devices Regulation in the European Union Albuquerque - 10 April 2012. Emmanuel Grimaud Perfea Innovation Lyon, France – Albuquerque, NM Info@perfea-innovation.com Cell : Emmanuel +33 (0) 679 110 579 - Antoine +1 917 617 8927. Emmanuel Grimaud

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Medical Devices Regulation in the European Union Albuquerque - 10 April 2012

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  1. Medical Devices Regulationin the European UnionAlbuquerque - 10 April 2012 Emmanuel Grimaud Perfea Innovation Lyon, France – Albuquerque, NM Info@perfea-innovation.com Cell : Emmanuel +33 (0) 679 110 579 - Antoine +1 917 617 8927

  2. Emmanuel Grimaud • Training : Engineer and post-doctorate • Aeronautics, Energy,and Defense • MedicalPhysics and Bioengineering • Chief of MedicalDevices Bureau at French Ministryof Healthat the time of EU directives final negotiations • Founder of the French Notified Body • AdvisortoSmall and Intermediate size businesses

  3. Agenda • Origin of Regulatoryframework in EU forMedicalDevices • Basic framework • New trends and expectedevolutions

  4. Origin of EU regulation • Before 1990, each EU country haditsownregulation for listedMedicalDevices • In 1990, EU movedtowards the Unique market concept for MedicalDevices in 3 steps : • With EU Directive 90/385/EEC for Active Implantable MedicalDevices • With the general EU Directive 93/42/EEC for MedicalDevices • With EU Directive 98/79/EC for In Vitro Diagnostics MedicalDevices • Completedlater • egEU Directive 2007/47/EC (Software…)

  5. Agenda • Origin of Regulatoryframework in EU forMedicalDevices • Basic framework • New trends and expectedevolutions

  6. Basic framework • MedicalDevice (and accessories) • Diagnostic, Therapy, or Compensation in and on the human body • Not acting primarily by pharmacological, immunological or metabolic means • Directives regulate • The “placing on the EU market” of a Medical Device for a given “intended purpose” • Risk classes • General rules are defined for the classification of MedicalDevicesintorisk classes • Routes to proveconformitydepend on the class

  7. Basic framework • Conformity • Manufacturer is responsible to certify conformity of the Device forclaimed performances and so called “essential requirements” mainly linked to Safety • Quality System for the manufactureroperationsand Technical File for the Device are the cornerstones of all conformityproofing routes • Clinical data, fromspecific investigation or literature serve as a key source for performance and safety • CE markingis the visible sign of Deviceconformity • « Harmonised standards » have been developedwhich support the conformityproofing: EN 46000 for Quality System or EN 60601 for electricalsafety…

  8. Basic framework • NotifiedBodies • They are notified by « Competentauthorities » (EU membersDoHs) for agiven scope (DM or IVD…) • Theyreceive the responsibility of assessing the manufacturer’sQuality Assurance Systems and/or the Device’sTechnical File, depending on the risk class • The manufacturer canchooseanyNotified Body within EU for the assessments

  9. Basic framework • Authorisedrepresentative • A manufacturer not established in the EU shouldcontractwith an EU-based « authorisedrepresentative » whoseresponsibilityitwillbe to act in lieu of the manufacturer in front of the authorities for anyregulatorymatter

  10. Basic framework • We have seenthat Directives regulate the “placing on the EU market” of a Medical Device • Specific provisions exist in the Directives for custom-made devices and devicesintended for clinical investigations • This frameworkiscompleted by : • Market surveillance and vigilance provisions for long term performances, incidents and frauds • Reimbursementschemesfocusing more on benefit • Use of « local » languageprovisions

  11. Agenda • Origin of Regulatoryframework in EU forMedicalDevices • Basic framework • New trends and expectedevolutions

  12. New trends and evolutions • EU regulationis a complexprocess • Consultations for a revision of the MedicalDevicesregulatoryframeworkwaslaunched back in 2008 • Discussions are stillongoing • Revisions are expected to bedrafted by end 2012 and mightbeadopted in 2013 • Implementationisthereforeexpected by 2016 • Main expectedevolutions are on • Clinical performances and clinical data especially for In Vitro Diagnostic Devices • Reprocessing of « single use » MedicalDevices

  13. Expectedevolutions • Clinical performances data for In Vitro Diagnostic Devices • Mandatorytodayonly for highestrisk class • Couldbeextended down to all classes exceptlowest • Post-marketclinical performance data • Not a requirementtoday but veryuseful in case of questions fromauthoritiesunder the vigilance scheme • Reprocessing of « single use » MedicalDevices • For decades, an endless « chicken and egg » story whichseems to come to a pragmatic (?) end : reprocessing of « single use » MedicalDevicewouldbeconsidered as new « putting on the market »

  14. Merci - Gracias Thankyou…

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