CUAP and ETA and CE

Common Understanding of Assessment Procedure (CUAP), European Technical Approvals (ETA), and CE marking
The Road to European Harmonisation
Traditionally, all European Member States have a variety of regulations concerning the use and installation of piping systems for different applications, in addition to the specifications and conformity controls for these systems. Since May 1985, the European Community (EC) has reinforced the process of replacing national regulations with European-wide standards through the creation of a "New Approach" defined in a Council Resolution. This New Approach is an innovative strategy with the aim of achieving European technical harmonisation. As a result, ever since this time, European Community Directives have laid down common technical requirements for each product category and procedures for assessing conformity. National authorities issue certificates of conformity, in accordance with the Directives, before products can be placed on the market.
These technical specifications are referred to as 'harmonised standards'. The Directives also lay down conformity assessment procedures for evaluating compliance with these directives.
As a means to reach the objective of harmonising certification practices, the European Committee for Standardisation (CEN = Comite European de Normalisation) Technical Committee has drafted standards, which are intended to serve as guidance for the drafting of individual certification schemes. This approach should eventually lead to European-wide harmonisation of certification schemes.
The Pipes Market
The Construction Products Directive (CPD) is one of the 'New Approach' directives, aiming at the harmonisation of standards and approval procedures, including those referencing pipes systems. New Approach directives provide for the affixing of the CE marking.As per the CPD, the future for the pipes industry approval processes lies with the creation of the Harmonised European Standards (hEN) which are currently being developed and will be approved in the coming years. These harmonised European Standards will make it possible for pipe systems manufacturers to apply for the CE marking through a fully self-certifying procedure which will give them the ability to distribute their pipe systems throughout Europe. Approvals through the country-by-country process will then become superseded by these harmonised approval processes. As long as the hEN for pipe systems has not been finalised, the sole way of obtaining this CE marking for pipe systems is for manufacturers to apply for European Technical Approval.
European Technical Approval (ETA)
In the case that no harmonized European specification exists or the product is not covered, the European Organisation for Technical Approvals (EOTA) and its approval bodies can issue a European Technical Approval (ETA), which allows the pipe system to be sold with the CE marking in the European Economic Area. European Technical Approvals (ETA) are based on a Common Understanding of Assessment Procedures (CUAP) for specific products. A CUAP is a procedure for innovative products which are not covered by any harmonized European specification but still bring a significant improvement to the industry.
PE-RT type I and II pipe systems eligible for CE marking
With a CUAP endorsed for type I and type II PE-RT pipe systems, there are two options open to manufacturers wanting to distribute PE-RT type I and/or type II systems in two or more European markets.
Obtaining separate approvals in each European country under national regulations.
Working with an EOTA partner to obtain a European Technical Approval and qualify to use the CE marking.
There are several important benefits for manufacturers using the ETA to gain a CE marking for their systems.
One approval that allows to sell PE-RT pipe systems in one go (which also makes it viable to sell in smaller markets where it would not have been practical to apply for individual approval)
Fewer administrative hassles and less cost in time and money than the current country-by-country process
Pipe systems are independently tested against performance standards agreed by certification institutes throughout Europe - standards that will be looked for by specifiers who demand quality systems.
Further information about the CUAP is available from the following organizations and Web sites:
European Commission, www.europa.eu.int/comm
EOTA, www.eota.be
Kiwa N.V., www.kiwa.nl
For more detailed information on DOWLEX PE-RT pipe system approvals, you can also contact us.

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USEFUL LINKS

Useful links

1. European Commission

• Medical devices - agenda of events 2010
• Public Health
• Scientific Committee
• Medicinal products
• Research & Development
• MD Working Groups & Task Forces
• CIRCA - Frequently Asked Questions (FAQ)

2. National Competent Authorities

• Contact points [133 KB]
• Vigilance contact points [119 KB]
• Clinical Investigation contact points [108 KB]
• CA meetings
• TSE-BSE contact points [93 KB]

3. Other contact points

• Notified Bodies
  • NANDO web site
  • European Association of Notified bodies for Medical devices (Team-NB)
  • Notified Body Operations Group (NBOG)
• European Committee for standardization (CEN)
• European Committee for Electrotechnical Standardization (CENELEC)
• The European Telecommunications Standards Institute (ETSI)
• European Trade Federations
  • European Coordination of the Radiological and Electromedical Industry (COCIR)
  • European Association of Authorized Representatives (EAAR)
  • European Diagnostic Manufacturers Association (EDMA)
  • European Hearing Instrument Manufacturers Association (EHIMA)
  • Medical Technologies Industry in Europe (EUCOMED)
  • European Federation of Precision Mechanical and Optical Industries (EUROM)
  • European Industrial Federation committe on Medical Technology (EUROM VI)
  • European Contact lens and lens care industry's association (EUROMCONTACT)
  • Federation of European Dental Industry (FIDE)

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