Transcript INTERNATIONAL MEDICAL DEVICE REGULATORS` FORUM
Competent Authorities’ Meeting on Medical Devices in Krakow A NEW MODEL FOR MULTILATERAL COOPERATION AND REGULATORY CONVERGENCE
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INTERNATIONAL MEDICAL DEVICE REGULATORS’ FORUM
IMDRF
Laurent Sellès DHoU SANCO B2 “Cosmetics and Medical Devices” CAMD 27.10.2011
From GHTF to IMDRF
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)
REFLECTION SEMINAR
5 JURISDICTIONS
’ SEMINAR HELD 15-17 FEB 2011 WASHINGTON DC
(EU REPRESENTED BY DE, FR, DG SANCO) OUTCOME OF THE SEMINAR: TIME FOR A CHANGE…
Time for a change!
Programming exit of GHTF… and Opening the steering committee to BRIC and WHO (5 ->10 members) Removing Industry from the steering committee A « Regulators only » steering committee Involvement of other Stakeholders Deployment tasks to be outsourced to other fora AHWP, APEC, WHO…
A vision for Medical Devices
International Regulatory Convergence
AHWP
New Global Regulators’ Forum Deployment fora
GHTF STEERING COMMITTEE MEETING 11-13 May 2011 BRISBANE
- Discussion of ‘closing the books’ of GHTF (until end 2012) - Clarification on Regulators’ decisions: Distinction of roles: ‘Regulators’, ‘Industry’, other ‘Stakeholders ’ - Steering Committee issued statement
STATEMENT OF GHTF SC BRISBANE MAY 2011 As well as progressing current work items, the Steering Committee had constructive discussions about activities.
the desirable elements and future arrangements for medical device harmonization All members medical re-affirmed continue to work together to achieve harmonized device regulatory recognizing the major role this activity has in supporting public health.
their commitment to requirements, This steering committee reflected on the excellent work of GHTF to date and members committed to using the work as part of the future harmonization endeavour.
OTTAWA meeting 6-7 October 2011 BRIC countries representatives invited to a ‘Regulators only’ meeting in Ottawa early October 2011. Representatives of Brazil (ANVISA), China (SFDA) and WHO attended.
For the EU: PL, DE, FR and DG SANCO Goal: To formalize the ‘vision of next phase’, to jointly define the operation of the new group.
New name: International Medical Device Regulators’ Forum (IMDRF) Terms of Reference in progress.
During 2012: GHTF Japanese Chair to close the books on pending GHTF work, while starting the new group . New group IMDRF operational in January 2012 under Australia Chair In 2013: The EU will chair IMDRF. Two meetings to plan (Spring – Autumn) Directorate-General Health & Consumers Unit B2 “Medical Devices and Cosmetics”
STATEMENT FROM IMDRF Ottawa 7 October 2011 IMDRF will accelerate international medical device regulatory harmonization.
The Forum
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s Management Committee, composed of regulatory officials, will provide guidance on strategies, policies, directions, membership and activities.
Furthermore the Management Committee will oversee Ad Hoc Working Groups which may draw upon expertise from various stakeholder groups such as industry, academia, health care professionals, and consumer and patient groups.
The IMDRF will meet bi-annually with the inaugural meeting taking place in early 2012 under the leadership of Australia.
As part of these bi-annual meetings stakeholders will have an opportunity to learn of the work of the Forum, provide input on emerging issues and suggest potential new work items.
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The terms of Main decisions of ‘Ottawa’ I reference organization still to be agreed.
of the new
- In
the Management Committee, each delegation has two representatives except for the EU delegation which has four (in order to take into account the shared competence with the MS). Each delegation shall have an equal voice in decisions.
- The
Management not by voting.
Committee will take decisions will be taken by consensus and - Implementation of agreed policy may be subject to an "opt-out", although this should be exceptional.
Main decisions of ‘Ottawa’ II
- The Forum will initially meet face-to face bi-annually with a rotating chair: Australia in 2012, the EU in 2013, the US in 2014 and Brazil in 2015. The MC will also have periodic web/teleconferences on a quarterly basis.
- The work plan will be undertaken by ad hoc groups, which will usually include stakeholders but may, exceptionally, be restricted to regulators.
- The fist list of work items for the new Forum was agreed. In particular it was agreed to continue the work on Unique Device Identification (UDI) chaired by the Commission. A working group will start work immediately on the implementation phase as presented in the proposal of August 22 and to report at the next Forum meeting, early 2012.