1. Pressure Equipment Workshop September 2007 – Day 2
Pressure Equipment Directive
Market Surveillance and
Role of the Regulator
Ed Haynes

2. Community legislation
Member States responsible for Market surveillance
Defined in horizontal Articles of Directives
Set up in horizontal regulation
In the revision of the New Approach, directives may include more specific market surveillance requirements (to be fulfilled by Member States)

3. Market Surveillance: Safeguard Clause
Detection of product on the market which is not safe to be used and/or is dangerous (normally by a national authority)
Clarify manufacturer/authorized representative/importer roles by market surveillance
If danger persists: withdraw product from the market, notify the Commission and other Member States
Investigation by the Commission
Commission Decision

4. Scope Consumer products Products for professional use
Priority for products with high potential risks
Placing on the market and putting into service

5. Objective of market surveillance
Products should satisfy community legislation
Ensure a high level of safety
Effective action against non compliant products
Functioning information exchange

6. Need for market surveillance
Reduced third party involvement in conformity assessment
Competition of Notified Bodies
Some Pressure Equipment is consumer product
Increasing imports from third countries

7. Responsibilities of Member States
Safety of Pressure Equipment in respect of market surveillance, Article 2 of PED or SPVD Article 2.
Notification of Conformity Assessment Bodies
Installation and the operation of PE (various approaches in Member States)

8. Tasks of Member States Establish a market surveillance system
Ensure adequate resources
Empower their authorities to take necessary measures
Draw up market surveillance programmes
Establish information and cooperation systems

9. Role of the Commission
Perform procedures of the safeguard clause (PED Article 8) and SPVD
Monitor Member States in regard of free movement of Pressure Equipment
Set up European co-operation and information on market surveillance
Coordinate common market surveillance projects

10. Role of the Notified bodies
Notified Bodies have an essential safety function in a global market
If lower safety levels are accepted, their role becomes counterproductive
Increasing importance of Member States Authorities monitoring Notified Bodies

11. Product Safety Directive (PSD)
For PE used as consumer products like vessels for air compressors, pressure cookers, the PSD also applies
For industrial Pressure Equipment only the relevant Articles of SPVD or PED apply

12. Specific problems in P E
Identification of defects
New approach allows different technical solutions
High potential risks
Imports from outside Europe
Consumer products as well as products for professional use
High number of consumer products

13. Experience
Most identified problems are with relatively cheap mass products (simple pressure vessels, pressure cookers) However, a “small” risk per item may generate a substantial risk for accidents due to the large number of products.
Sometimes difficult to distinguish responsibilities amongst manufacturer, distributor, authorized representative, e.g. insufficient labeling, access to documentation

14. Overview

15. Incomplete fusion

16. Formal problems Formal safeguard procedures take a long time
Member States unlikely to use safeguard clause if problem is solved internally
Other Member States receive information too late or no information at all

17. Detection of non compliant PE
Use of information tools like ICSMS, RAPEX, CIRCA
National Authorities must provide the information to these systems and in time
Information on test results and possible distribution channels

18. Cooperation on European level ADCO Group
Sectoral group of National Authorities and the Commission
Exchange expertise, develop best practices
Set up and carry out shared market surveillance programmes
Share information when non compliant pressure equipment is detected
Cooperate on measures against dangerous products

19. Administrative Co-operation
Individual Member States have limited resources but collective strength
ADCO groups WGA & WPA established in 2004
Comprise representatives from public administrations only
Information exchange, co-operation, common concepts and actions for the surveillance/designation of products and notified bodies
Chaired by Member States, supported by the Commission
Regular meetings, web-based communication (CIRCA, ICSMS)
“Constitution” established
May extend ADCO activities with the revision of New Approach
WG 6 (Article 6) and OAEn procedure (Vademecum) 2006/2007

20. The Manufacturer
Person who is responsible for designing and manufacturing a product, with a view to placing it on the Community market, on his own behalf.
obligation to ensure that product is designed and manufactured, and its conformity assessed, all to the Essential Requirements in applicable New Approach directives.
May use finished products, ready-made parts or components, or may subcontract these tasks. However, he must always retain the overall control and have the necessary competence to take the responsibility for the product.

21. The Authorised Representative
Any natural or legal person appointed by the manufacturer to act on his behalf.
Must be established inside the Community.
May be addressed by authorities of the Member States instead of the manufacturer with regard to obligations under a New Approach directive.
Manufacturer remains generally responsible for actions carried out by an authorised representative on his behalf.

22. International Co-operation
has details on Mutual Recognition Agreements,
Agreements on Conformity Assessment and Acceptance of Industrial Products
This includes positive relationships with countries in the Eastern Mediterranean, North Africa and some of the former Soviet Republics and parts of former Yugoslavia not presently in EU.
In some cases this involves legislation based on or similar to the European Directives and / or the role of standards