Meeting Report
CEOC International - Cabinet of John
Dalli
Date and
place of the meeting: Tuesday, 5th June 2012, Berlaymont,
Brussels
Participants: Mrs
Joanna Darmanin, Head of Cabinet, DG
SANCO
Mrs
Rossella Delfino, Member of Cabinet,
DG SANCO
Mr
Octavian Vasile, Policy Officer
Product and Service Safety, DG SANCO
Mr
Drewin Nieuwenhuis, Secretary
General CEOC International
Mr Daniel Pflumm,
Chairman of TC Conformity Assessment (CC)/ VdTÜV
Mr
Thomas Grusemann, TÜV Rheinland EU
Liaison Office
Ms Franziska Kassler,
International Affairs Manager CEOC International
The DG Health and Consumer
(DG SANCO) under Commissioner John Dalli (Malta) is responsible for product and
food safety, consumer rights and health and as such an important contact
partner for CEOC International.
After an introduction
of CEOC International by CEOC Secretary General the following topics were
discussed:
- General Product Safety
Directive:
The Commission representatives explained that the two services in charge,
DG SANCO and DG ENTERPRISE, have come to an agreement regarding the text of the
revision. An Impact Assessment will be launched by the end of July. The adoption of the proposal is expected to
take place in November or December this year. The aim of this revision is
the simplification of current legislation. The provisions on market
surveillance in Regulation 765/2008, chapter 3, will be taken out of the
regulation and will be combined with market surveillance provisions of the
GPSD. Regulation 765 will then only be dealing with accreditation and CE
marking while all requirements for market surveillance are going to be dealt
with in the revised GPSD.
In the future there will also be only one notification procedure for
dangerous products. All products will be notified to RAPEX and only in cases
where the member states do not agree on the tests to be conducted there will be
a separate procedures afterwards. 
Joanna Darmanin raised the issue
that for smaller Member States it is more difficult to identify competent
partners in product testing. Daniel Pflumm proposed to think about the
introduction of an EU-wide data base of competent and accredited bodies
performing product test in the non harmonised area as NANDO only lists NB’s under EU-Directives.
Daniel Pflumm
also advocated maintaining recital 17 of the existing General Product Safety
Directive “Appropriate independent certification recognised
by the competent authorities may facilitate proof of compliance with the
applicable product safety criteria…”
- Medical Device Directive:
The Commission draft for the
revision of the Medical Device Directive will soon be submitted to the European
Parliament and the European Council. The current version does not foresee any
requirements for a pre-authorisation of medical devices and is thus not
following the resolution of the parliament’s ENVI committee. However, the
pressure for action is high both in the Parliament and in the Council, which is
why it is highly likely that requests for changes will come up during the
co-decision procedure. Mrs Darmanin explained that there is some resistance to
the current draft proposal. The Commission’s aim is to have the revision
proposal adopted in the third week of
September.
Thomas Grusemann reported briefly on the meeting of a group of Medical
Notified Bodies (Team NB ) with
Commissioner Dalli and other Commission staff. Due to the strong support of
John Dalli of the Code of Conduct (COC) adopted by several NBs and the
expressed wish to extend the adoption of the COC by more NBs, Team-NB has
started the process of defining work packages that can progressively be adapted
by more NBs. As soon as first results are achieved, Team-NB will report back to
John Dalli’s cabinet.
Daniel Pflumm reported briefly about an audition on safety of medical
devices organized by the French Sénat in which he took part together with two
other VdTÜV representatives.
In general Commissioner Dalli’s cabinet
demonstrated a strong interest in the contribution of independent testing,
inspection and certification bodies to the safety of European societies and its
citizens. It seems that the political winds in Brussels are changing with
growing political and public support for supervision and control of the
markets. Questions were asked about the importance of the emerging markets and
how the TIC sector is dealing with products coming from these markets and about
the costs of product testing, especially with regards to the smaller EU member
states, which might not always have the same resources and infrastructures for
conducting product certification as the big ones.
EC Commissioner Dalli will be
invited as a key note speaker at the CEOC International Safety Seminar in
November in Brussels to further discuss the issue of costs of product certification
in relation to the manufacturing and distribution costs of consumer products (and
services).
For further information please contact franziska.kassler@ceoc.com