Competent Authorities’ Meeting
on Medical Devices in Krakow
A NEW MODEL FOR MULTILATERAL COOPERATION
AND REGULATORY CONVERGENCE
--------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 the desirable elements and future
arrangements for medical device harmonization
activities.
All members re-affirmed their commitment to
continue to work together to achieve harmonized
medical
device
regulatory
requirements,
recognizing the major role this activity has in
supporting public health.
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
harmonization.
international
medical
device
regulatory
The Forum’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.
Main decisions of ‘Ottawa’
I
-
The terms of reference of
organization still to be agreed.
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 Committee will take
decisions will be taken by consensus and
not by voting.
- 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.
Questions/Answers
The EU participating team:
Joanna, Jean-Claude, Matthias
and me are happy to discuss…
Thank you for your attention!