Review of the New Approach - Orgalime views on conformity assessment modules

Published: 14 April 2005

Policies & Issues: Internal Market - Compliance, Standards & Enforcement

Response to the European Commission - Mr. J. McMillan

Orgalime believes that the conformity assessment modules generally are efficient for their intended purpose and give rise to few significant problems. In particular, we urge regulators to continue to make use of Module 'A' (self declaration of conformity) as the default choice in any new or revised product legislation.  Module 'A' does not need any additional requirements in order to have credibility.

In order to adapt the modules to current practice, in addition to taking account of the revision of standard ISO 9001, Orgalime also proposes a slight amendment to module B in accordance with Directive 2004/22/EC Measuring instruments, where type testing may also be conducted in the form of evaluation of design documentation.  Such an amendment would be very advantageous for highly innovative and expensive instruments.

See encloosed our proposal in a graphical form.

References: EC letter ENTR/C1/GA/ah D(2005)4553 dated 24/02/2005

Related Position Papers

Internal Market: For a restored mutual trust in a market-relevant European Standardisation System [24 September 2019]

Towards effective, efficient EU market surveillance: all for a level-playing field without additional burdens for legitimate manufacturers [6 December 2018]

For simpler compliance with and smarter enforcement of EU harmonisation legislation: Orgalime comments on the amendments of the European Parliament to the Commission proposal on Compliance and Enforcement [6 July 2018]

For simpler compliance with and smarter enforcement of EU harmonisation legislation: comments on the Commission proposal for a Regulation laying down rules and procedures for compliance with and enforcement of Union harmonisation legislation on products [5 April 2018]

Orgalime calls for improved enforcement of harmonisation legislation for safe and compliant products [21 February 2018]

Simpler and more effective market surveillance of products is urgently needed [21 September 2017]

Orgalime guidance on the manufacturer’s obligations for the combination of a machine with radio equipment [12 June 2017]

Call to preserve the EU ‘New Approach’ as one of the Single Market’s best regulatory techniques [8 March 2017]

For an efficient market surveillance of online trade: suggestions for the better handling of fulfilment centres in the enforcement of EU harmonisation legislation [13 February 2017]