Revision of the Medical Device Directives The case

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

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 (drugdevice combination products)

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

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

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

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 multinational clinical investigations

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

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)

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)

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

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

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

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

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

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