1

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

2

Beyond the directive 2007/47: Recast, New “New Approach”, Global Armonization

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

Beyond the directive 2007/47: Recast, New “New Approach”, Global Armonization 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

Beyond the directive 2007/47: Recast, New “New Approach”, Global Armonization

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

Beyond the directive 2007/47: Recast, New “New Approach”, Global Armonization

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

Beyond the directive 2007/47: Recast, New “New Approach”, Global Armonization

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

Beyond the directive 2007/47: Recast, New “New Approach”, Global Armonization

Thank you!