1. 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

2. Emmanuel Grimaud – Training : Engineer and post-doctorate Aeronautics, Energy, and Defense Medical Physics and Bioengineering – Chief of Medical Devices Bureau at French Ministry of Health at the time of EU directives final negotiations – Founder of the French Notified Body – Advisor to Small and Intermediate size businesses

3. Agenda Origin of Regulatory framework in EU for Medical Devices Basic framework New trends and expected evolutions

4. Origin of EU regulation Before 1990, each EU country had its own regulation for listed Medical Devices In 1990, EU moved towards the Unique market concept for Medical Devices in 3 steps : – With EU Directive 90/385/EEC for Active Implantable Medical Devices – With the general EU Directive 93/42/EEC for Medical Devices – With EU Directive 98/79/EC for In Vitro Diagnostics Medical Devices Completed later – eg EU Directive 2007/47/EC (Software…)

5. Agenda Origin of Regulatory framework in EU for Medical Devices Basic framework New trends and expected evolutions

6. Basic framework Medical Device (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 Medical Devices into risk classes – Routes to prove conformity depend on the class

7. Basic framework Conformity – Manufacturer is responsible to certify conformity of the Device for claimed performances and so called “essential requirements” mainly linked to Safety – Quality System for the manufacturer operations and Technical File for the Device are the cornerstones of all conformity proofing routes – Clinical data, from specific investigation or literature serve as a key source for performance and safety – CE marking is the visible sign of Device conformity – « Harmonised standards » have been developed which support the conformity proofing: EN 46000 for Quality System or EN 60601 for electrical safety…

8. Basic framework Notified Bodies – They are notified by « Competent authorities » (EU members DoHs) for a given scope (DM or IVD…) – They receive the responsibility of assessing the manufacturer’s Quality Assurance Systems and/or the Device’s Technical File, depending on the risk class – The manufacturer can choose any Notified Body within EU for the assessments

9. Basic framework Authorised representative – A manufacturer not established in the EU should contract with an EU-based « authorised representative » whose responsibility it will be to act in lieu of the manufacturer in front of the authorities for any regulatory matter

10. Basic framework We have seen that Directives regulate the “placing on the EU market” of a Medical Device Specific provisions exist in the Directives for custom-made devices and devices intended for clinical investigations This framework is completed by : – Market surveillance and vigilance provisions for long term performances, incidents and frauds – Reimbursement schemes focusing more on benefit – Use of « local » language provisions

11. Agenda Origin of Regulatory framework in EU for Medical Devices Basic framework New trends and expected evolutions

12. New trends and evolutions EU regulation is a complex process – Consultations for a revision of the Medical Devices regulatory framework was launched back in 2008 – Discussions are still ongoing – Revisions are expected to be drafted by end 2012 and might be adopted in 2013 – Implementation is therefore expected by 2016 Main expected evolutions are on – Clinical performances and clinical data especially for In Vitro Diagnostic Devices – Reprocessing of « single use » Medical Devices

13. Expected evolutions Clinical performances data for In Vitro Diagnostic Devices – Mandatory today only for highest risk class – Could be extended down to all classes except lowest Post-market clinical performance data – Not a requirement today but very useful in case of questions from authorities under the vigilance scheme Reprocessing of « single use » Medical Devices – For decades, an endless « chicken and egg » story which seems to come to a pragmatic (?) end : reprocessing of « single use » Medical Device would be considered as new « putting on the market »

14. Merci - Gracias Thank you…