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BEYOND THE DIRECTIVE 2007/47: RECAST, NEW “NEW APPROACH”, GLOBAL ARMONIZATION

BEYOND THE DIRECTIVE 2007/47: RECAST, NEW “NEW APPROACH”, GLOBAL ARMONIZATION III NATIONAL CONFERENCE ON MEDICAL DEVICES Rome 13 – 14 April 2010 Carmen Abad. 1990 – 2010: Twenty years of Medical Devices Directives Aims Functioning of the internal market

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BEYOND THE DIRECTIVE 2007/47: RECAST, NEW “NEW APPROACH”, GLOBAL ARMONIZATION

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  1. BEYOND THE DIRECTIVE 2007/47: RECAST, NEW “NEW APPROACH”, GLOBAL ARMONIZATION III NATIONAL CONFERENCE ON MEDICAL DEVICES Rome 13 – 14 April 2010 Carmen Abad

  2. 1990 – 2010: Twenty years of Medical Devices Directives Aims Functioning of the internal market High level of protection of human health and safety Have we reached these aims?

  3. Functioning of the internal market? MS do not create any obstacle to CE marked medical devices, but: Different definitions interpretations Different national control measures UE Market not traceable False CE marked/counterfeit devices

  4. High level of protection of human health and safety? Conformity assessment by a Notified Body, but: Inconsistent NB Designation and monitoring Insufficient clinical evidence Uncertainty on New technologies evaluation Delegation of Responsibilities (False medical devices manufacturers)

  5. Finding solutions (regulatory) To complete UE MD directives with: Centralized decision-maker body Traceability requirements CA Participation in assessment procedures of sensible MD Improve CA market information provisions Mandatory Guidelines on key subjects

  6. Finding solutions (operational) To increase sharing CA activities on NB designation and monitoring To re-design EUDAMED as a complete system of UE marketed medical devices information To improve CA collaboration on market surveillance cases and programs To extend CA surveillance activities to fields not covered on MD directives (sale and distribution chains, advertising, customs)

  7. Thank you!

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