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