1. 1 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

2. 2 Points to cover  Market surveillance: the context and the substance  Market surveillance: the means  Cooperation at European level: the envisaged practice

3. 3 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 The New Approach, the context for Market Surveillance

4. 4 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

5. 5 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

6. 6 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.

7. 7  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 Member States’ action in case of unduly affixed CE marking

8. 8  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) Member States’ safeguard action (art. 19, MID)

9. 9 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

10. 10 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

11. 11  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 Common actions: how

12. 12 Our hope is that this meeting will be the first step in developing common actions in 2009 Thank you! European Commission:  Daniel.Hanekuyk@ec.europa.eu Daniel.Hanekuyk@ec.europa.eu  Lucia.Palmegiani@ec.europa.eu Lucia.Palmegiani@ec.europa.eu