MARKET SURVEILLANCE IN THE
EUROPEAN UNION
A coordinate approach for metrology
Lucia Palmegiani
Policy Officer, DG ENTR I.5
WELMEC, WG 5, Malta, 23 October 2008
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Points to cover
Market surveillance: the context and the substance
 Market surveillance: the means
 Cooperation at European level: the envisaged practice
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The New Approach, the context for Market Surveillance
New Approach Directives: harmonisation at European level
the aims
 For Users/Consumers: high level of metrological control
 For Manufacturers: free movement within the common market
the means
Setting essential requirements, not technical solutions
Coordinated market surveillance
Competent conformity assessment
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Compliance with ERs whose responsibility is it?
Manufacturer
 Designing and manufacturing instrument for the Community market
 Bringing the instrument complies with ERs
 Making sure that the instrument is conformity assessed
 Affixing M- and CE-marking & draft the EC declaration of conformity
Notified Body
 Implementation of conformity assessment
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Role of Member States
Member States are responsible for the correct and full application of the
Directives on their territory. Member States shall:
 Ensure proper implementation
 Appoint and monitor of notified bodies
Designate competent authorities for the exchange of information
 Exchange information with other authorities
 Market surveillance; verification of documents
 Intervention in case of unduly affixed CE marking
 Issue safeguard clauses
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Market Surveillance
Basis : Art 18, point 1 of the Measuring Instruments Directive
“Member States shall take all appropriate measures to ensure that
measuring instruments that are subject to legal metrological
control but do not comply with the applicable provisions of the
MID are neither placed on the market nor put into use”.
Role of Market Surveillance
Protection of consumers/users and fair competition
Role of the European Commission
Ensure that cooperation between market surveillance authorities
is sufficient and examine safeguard actions.
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Member States’ action in case of unduly affixed CE
marking
Basis for action, art. 20
- The CE marking and/or the supplementary metrology marking
on the product are not complying with the Directive
-Not all the administrative provisions required by the Directive
have been met
However, any decision shall state the exact ground on which it
is based (art. 21)
Consequences
Manufacturer or authorized representative shall be obliged by
Member States to the make product conform and to end
infringement under the conditions imposed by the Member States
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Member States’ safeguard action (art.
19, MID)
 Basis
for action
Failure to satisfy essential requirements.
Appreciation
Member States shall take account of the systematic or incidental nature of
the non-compliance.
 The role of the European Commission
Verify correct implementation of Community law with respect to the
product that comply with the requirements of the Directive, come to a
European wide solution, protecting interests at the European level.
However, any decision shall state the exact ground on which it is based
(art. 21)
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Administrative Cooperation
Basis: Art. 18 of the Measuring Instruments Directive
Tasks and objectives for authorities involved in market surveillance and
monitoring of Notified Bodies:
 Ensure efficient co-operation at EU national levels
 Provide assistance and information to other Member States
 Development of guidelines
 Share expertise and best practices
 Realise common actions
Tools:
 Meetings of Welmec WG5
 Electronic communication platform (CIRCA)
 Common actions
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Common actions: why?
 Member States have limited capabilities and
market surveillance must cover all the EU market,
 The logic is to pool some resources in
COMMON ACTIONS
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Common actions: how
 Define areas of action
 Define strategies of action
 Give actions prior publicity (or not?)
 Divide tasks (Who does what)
 TAKE THE ACTION
 Analyse the results and, if needed, follow-up
 Report on the actions and follow-up
 Publicise the report
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Our hope is that this meeting will be the first step in developing
common actions in 2009
Thank you!
European Commission:
 [email protected]
 [email protected]
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