What is different in the European (CE Mark) and the American medical - PowerPoint PPT Presentation

What is different in the European (CE Mark) and the American medical device (FDA) approval path and what does a CE-Mark or a FDA approval mean for a physician using devices ? 7th European Symposium of Vascular Biomaterials Nicolas Thevenet, Head of Market Survey Department Strasbourg, May 13, 2011

1 Life cycle of a medical device in the European ! ! model Comparison with the FDA model ! ! ! Prospects

2 Market Regulation in Europe • Free circulation on the European market after CE mark in compliance with EU directives : – Directives 90/385/EEC (AIMD) and 93/42/EEC (MD) modifided by directive 2007/47/EC • Complemented by technical directives : origin animal MD, reclassification (breast implants, Hip implants ! ) ! Mandatory for the manufacturers : essentiels requirements (ER), procedures of placing on the market (depending of the MD classification)

3 Life cycle of a medical device ! Design (technological approach) ! Conformity assessment - clinical investigation (Competent Authority-CA) ! CE certification : audit of quality system and technical documentation (by a notified body-NB) ! Market survey after placing on the market ! Follow up audits (NB) ! Interventions CA : - Conformity assessment, reassessment benefit / risk - Vigilance ! Minor essential changes, end of sale, new MD

4 Evaluation of conformity ! ! Assessment of compliance with essential requirements (Annex I) : - risk analysis (patient, user, ! ) - preclinical evaluation (biocompatibility, laboratory testing, animals testing) - clinical evaluation (annex X) - manufacturing, sterilization ! With the use of EN harmonized standards or justification of an alternative reference ! ! Technical, documentation, labelling and instruction for use Conclusion : acceptable risks weighed against the benefits to the patient

5 Compliance certification • ! For a procedure provided by Directive risk level (4 classes based on criteria in information of Annex IX) : - Declaration of conformity to class I (except Im, Is) - Certificate of conformity by a notified body and a maximum of 5 year follow-up audits : - for class IIa and IIb by control on technical documentation sampling - for class III product by product with design examination ! Conduct to affix the CE mark by the manufacturer. It takes responsibility for placing on the market : no direct intervention by the competent authority

6 FDA model • ! FDA responsible for market access • ! 2 kinds of process : - 510 k premarket notification - PMA premarket approval • ! Clinical investigations (IDE process) required depending on the level of risk associated

7 Procédure for placing on the market 510 (k) : Notification premarket - Generally Class II - based on equivalence (use claims, technological characteristics) PMA : Approbation premarket - Generally class III and innovative MD - based on scientific evidence to demonstrate safety and efficacy ! FDA discussed with the manufacturer before placing on the market

8 Example : Class III – High risk Generally EU US Clinical IDE Clinical data investigations authorization Quality system Full Quality System Full Quality System regulation - Notified body - ! FDA Procedure - Certificat of - ! PMA conformity

9 Finally ! • ! In Europe, the competent authorities don’t intervene before the placing on the market ! in France : search of accompaniment of the innovation • ! Convergence of classes, methods, standards, between the 2 models, even if the FDA approves ! Global Harmonisation Task Force (GHTF) describing a global model

10 European Regulatory changes Major objectives of progress • Summary of the characteristics of MD • Unique device identifier (european data base) • Creation of an European committee for MD ? • Intervention by the CA before CE : opinion on evaluation reports established by the NB

11 Thank you for your attention