GLOBAL HARMONIZATION TASK FORCE (GHTF)

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UPDATE: PLANNING THE 2012 ACTIVITIES

Laurent Sellès DHoU SANCO B2 “Cosmetics and Medical Devices”

CAMD 28.10.2011

Competent Authorities’ Meeting on Medical Devices

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

Adoption of GHTF guidelines –comparison between jurisdictions

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

AUS CND EU JPN USA

not adopted

pending adoption

adopted in part

adopted in full

May 2011 Europe’s participation in GHTF

Steering CommitteeLaurent 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 evaluationChair [N. Shadeed (CAN)]P. Bischoff-Everding (COM)Alan Green (EUROM VI)Peter Linders (COCIR)

_______________SG1 Subgroup IVDMarie-Lise Migueres (FR)Céline Bourguignon (COM)Benny Ons (EDMA)Michael Thein (EDMA) Petra Kaars Wiele (EDMA)

SG2 Post market surveillance /vigilanceChair Isabelle Demade (COM)

Carmen Ruiz-Vilar (ES) Ekkehard Stösslein (DE)Philippe Auclair (Eucomed)Bertram König (Eurom VI)

SG3 Quality systemChair Egan Cobbold (CAN)Rainer Edelhäuser (DE)Carlos Arglebe (Cocir)Emmett Evereux (Eucomed)

SG4 AuditingChair Jan Welch

(USA)Maintenance mode

Peter Studer (CH)Philippe Lartigue (Cocir)Bertram Koenig (EuromVI) François Simondet (EuromVI)Stefan Preiss (EU NB)John Worroll (EU NB)

SG5 Clinical safety & PerformanceChair 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 Höke (COM)

AHWG “UDI”Chair: Laurent Sellès (COM)

Matthias Neumann (DE)Jesus Rueda (EDMA)

Volker Zeinar(Eucomed)

AHWG “IAF” (International Accreditation Forum)

Chair: Roland Rotter/Egan Cobbold (CAN)

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)

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.

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…

SG2-SG5 joint action

Completion of the proposed guidance on

AE reporting during

pre-market clinical investigation.

Also in 2012…

SG1-SG5 joint actionFinalization of the proposed documents:

Clinical evidence for IVDs: key definitions & concepts.

Clinical evidence for IVDs: scientific validity determination and performance evaluation.

Under development: Clinical performance studies for IVDs.

Also in 2012…