1. GLOBAL HARMONIZATION TASK FORCE (GHTF) --------- UPDATE: PLANNING THE 2012 ACTIVITIES Laurent Sellès DHoU SANCO B2 “Cosmetics and Medical Devices” CAMD 28.10.2011 Competent Authorities’ Meeting on Medical Devices

2. Global Harmonisation Task Force - Conceived in 1992, rotation of Chairmanship every 3 years - Purpose: international harmonization in MD regulations for safety, effectiveness, performance adequacy/quality of MDs - Publication of harmonized guidance docs on regulatory practices. - Guidance docs for adoption by Regulatory Authorities. - GHTF cooperates with Asian Harmonisation Working Party AHWP

4. May 2011 Europe’s participation in GHTF Steering Committee Laurent Sellès (COM) - Matthias Neumann (DE) Joanna Kilkowska (PL) – Jean-Claude Ghislain (FR) Benny Ons (EDMA) - François Simondet (EUROM VI) Jean-Yves Carentz (Eucomed) – Nicole Denjoy (COCIR) SG1 Premarket evaluation Chair [N. Shadeed (CAN)] P. Bischoff-Everding (COM) Alan Green (EUROM VI) Peter Linders (COCIR) _______________ SG1 Subgroup IVD Marie-Lise Migueres (FR) C é line Bourguignon (COM) Benny Ons (EDMA) Michael Thein (EDMA) Petra Kaars Wiele (EDMA) SG2 Post market surveillance /vigilance Chair Isabelle Demade (COM) Carmen Ruiz-Vilar (ES) Ekkehard St ö sslein (DE) Philippe Auclair (Eucomed) Bertram König (Eurom VI) SG3 Quality system Chair Egan Cobbold (CAN) Rainer Edelh ä user (DE) Carlos Arglebe (Cocir) Emmett Evereux (Eucomed) SG4 Auditing Chair Jan Welch (USA) Maintenance mode Peter Studer (CH) Philippe Lartigue (Cocir) Bertram Koenig (EuromVI) Fran ç ois Simondet ( EuromVI) Stefan Preiss (EU NB) John Worroll (EU NB) SG5 Clinical safety & Performance Chair S. Ludgate (UK) Wolfgang Ecker (AT) Isabel Scuntaro (CH) Benny Ons (EDMA) Christian Bailleul (Eucomed) Peter Rattke (COCIR) AHWG GMDN (Chair Rohan Hammett AUS) Susanne H ö ke (COM) AHWG “ UDI ” Chair: Laurent Sell è s (COM) Matthias Neumann (DE) Jesus Rueda (EDMA) Volker Zeinar(Eucomed) AHWG “ IAF ” (International Accreditation Forum) Chair: Roland Rotter/Egan Cobbold (CAN)

5. European coordination Information of progress of reflection: -MDEG (June, November 2010) and CA meetings (March, September 2010, February 2011) -Regular preparatory meetings prior to GHTF Steering Committee sessions (MS, Industry invited) In the Steering Committee, MS represented - by DE, NL, IT (in 2007-2008) - by DE, IT, PL (in 2009-2010) - by DE, PL, FR (in 2011)

6. STEERING COMMITTEE MEETING 11-13 May 2011 BRISBANE At the Steering Committee (SC) meeting in Brisbane: - Japan (SC Chair) decided to : - cancel the SC meeting planned in October 2011 - maintain the two SC meetings April and October 2012 -2012 will be for ‘closing the books’. -A conference could be part of an SC meeting and acknowledge the achievements of GHTF.

7. SG1 work programme  Out for public comments (until 5 Feb. 2012): Principles of Conformity Assessment for Medical Devices (SG1(PD)/N078R03); Principles of Medical Devices Classification (SG1(PD)/N077R04)  Finalization of the revision of: Definition of the Term "Medical Device“; Essential Principles of Safety and Performance of Medical Devices  Cooperation of IVD subgroup with SG5: 3 guidance documents related to clinical evidence (see next slide) Prior to GHTF closure…

8. IVD subgroup / SG 5  Out for public comments (until 21 March 2012): Clinical Evidence for IVD Medical Devices - Key Definitions and Concepts (SG5(PD)/N6R3); Clinical Evidence for IVD Medical Devices - Scientific Validity Determination and Performance Evaluation (SG5(PD)/N7R4)  Finalization of working draft: Clinical performances studies for In Vitro Diagnostic Medical Devices Prior to GHTF closure…

9. SG2 work programme  Finalize N111 on the def. & classification of FSCA.  Finalize N87 on the electronic transfer of AE data between MFRs, Authorised Reps and NCAs.  Publication of info on the SG2 NCARs Exchange Programme (incl. NCARs stats) on GHTF website. Prior to GHTF closure…

10. SG2-SG5 joint action Completion of the proposed guidance on AE reporting during pre-market clinical investigation. Also in 2012…