1. STATE OF THE ART AND PERSPECTIVES IN MEDICAL DEVICE LEGISLATION 3rd National Conference on Medical devices Roma, 13th April 2010 Sabine Lecrenier Head of Unit Cosmetics and medical devices This contribution was prepared by Ms Sabine Lecrenier, DG SANCO © European Union, 2010. The views expressed in this contribution are those of the author and do not necessarily reflect the official position of the European Commission. Neither the European Commission nor any person acting on its behalf is responsible for any use that might be made of the following information

2. Directive 2007/47/EC = improvements introduced  Clinical evaluation  Conformity assessment procedures  Consultation for combination products  New essential requirements  Decisions on qualification aspects

3. Directive 2007/47/EC = implementing measures  EUDAMED Decision  E-labelling  AIMDs manufactured utilizing tissues of animal origin  Vigilance procedures

4. Reprocessing of medical devices  2007: Public consultation  2008: Workshop  2009/2010 : SCENIHR opinion  Sept. 2010 : EC report to the EP and to the Council

5. vCJD assays  Amendment of Annex II List A of Directive 98/79/EC (addition of blood screening, diagnostic and confirmatory vCJD assays)  Common Technical Specifications for blood screening vCJD assays

6. Recast of the medical devices Directives Structural shortcoming unsolved Need for a more systemic revision of the regulatory framework

7. Recast of the medical devices Directives – Public consultation 200 responses Many concerns shared by Member States and stakeholders… … but more time was needed

8. Recast of the medical devices Directives – Aims  High level of health protection in a properly functioning Internal Market  International trade  Global challenges

9. Conclusion Directive 2007/47/EC Important improvements Implementing measures … but still structural shortcoming unsolved … Proposed Recast High level of health protection Proper functioning of the Internal Market Competitiveness and innovation

10. Thank you for your attention ! Sabine LECRENIER Head of Unit « Cosmetics and Medical Devices » European Commission DG Health & Consumers sanco-cosmetics-and-medical-devices@ec.europa.eu http://ec.europa.eu/enterprise/medical_devices/