1. Revision of the Medical Device Directives The case of ‘Borderline’ Products used in a self-care context 48th AESGP Annual Meeting Nice, 6-8 June 2012 Laurent SELLES Directorate-General Health and Consumers

2. Present regulatory framework (Directives: 90/385/EEC, 93/42/EEC, 98/79/EC) Safety of patients, users and other persons Internal market Innovation-friendly Competitiveness of industry Specificities of the sector Interface medical devices - pharmaceuticals (drug-device combination products)

3. Now we are preparing a „Revision“ Build on the strengths … Supportive to innovation Rapid access to market Balance between pre- and post-market control Cost-effective SMEs … but adapt and improve

4. Proposals for the future regulatory framework Scope Products manufactured utilising non-viable human tissues/cells Invasive devices without medical purpose (e.g. aesthetic devices) Reprocessing of single-use devices „In house“ tests Genetic tests Medical devices used for diagnostic services at a distance    the self-care context is a society trend

5. Proposals for the future regulatory framework Supervision of Notified Bodies Uniform practice for the designation and monitoring of notified bodies Uniform standards of conformity assessment by notified bodies

6. Proposals for the future regulatory framework Clinical evidence Clinical data to be submitted for pre-market assessment Post-market clinical follow-up Rules on clinical investigations and coordination of safety-related aspects of the assessment of multi- national clinical investigations

7. Proposals for the future regulatory framework Post-market safety Consistent and timely reactions to safety issues Enhanced coordination of analysis of vigilance cases and market surveillance activities Enhanced involvement of healthcare professionals and patients

8. Proposals for the future regulatory framework Transparency Central registration of medical devices and relevant economic operators Summary of safety and performance data Traceability of devices (e.g. UDI)

9. Proposals for the future regulatory framework Access to external expertise Panel of clinical and scientific experts Network of reference laboratories (esp. in the field of IVDs)

10. Proposals for the future regulatory framework Governance Infrastructure and mechanim for harmonised interpretation and implementation Administrative, technical and scientific support (incl. IT infrastructure) by an EU body Cross-sectoral solution of borderline cases

11. State of play and next steps Public consultations General (2008) IVD Directive (2010) Impact assessment September 2011 Commission proposals Summer 2012 Ordinary legislative procedure European Parliament and Council

12. The case of ‘Borderline’ Products used in a self-care context The scope of the proposed Regulation must be clearly defined versus the other regulated products, in particular: - medicinal products covered by Directive 2001/83/EC. -In deciding whether a product falls under that Directive or this Regulation, particular account shall be taken of the principal mode of action of the product. - food products covered by Regulation (EC) 178/2002 - cosmetics covered by Regulation (EC) 1223/2009

13. Clear delimitation of scope among the different regulated products is of paramount importance for a uniformed application in the EU and EEA

14. Now in the middle of inter-service consultations A critical phase before the adoption by the Collège

15. Thank you for your attention… For more information, please visit our site: http://ec.europa.eu/health/medical-devices