Product Safety Professionals, The 'New Approach' adopted by most European Directives is intended to enable manufacturers to declare conformity via EITHER the 'essential requirements' OR the 'harmonized standards' -- With the understanding that conformance to harmonized standards (as listed in the Official Journal of the European Communities) provides a 'presumption of conformity' to the Directives.
For manufacturers who are currently declaring conformity via the harmonized standards route for Machinery and/or Low Voltage Directive, I would really be interested in the following: 1. When a manufacturer declares conformity to a list harmonized standards, are they also, in effect, declaring conformity to all of the 'Normative References' called out within the harmonized standards? 1A. Follow-up to Question No. 1: If the harmonized standards you declare against references other PrEN or IEC standards in the 'Normative References' that are NOT specifically listed in the Official Journal of the European Communities for the Directive? 2. If a manufacturer chooses to pursue the harmonized standards route, who determines whether the manufacturer has actually applied ALL of the applicable standards. In the case of a large, multi-module industrial machinery, a manufacturer can easily be expected to comply with EN 60204, EN 292, EN 349, EN 418, EN 294, EN 457, EN 1050, etc. (Keep in mind that even if you utilize a Competent or Notified Body, the manufacturer is still self-declaring!) 3. For manufacturers that declare conformance to the standards route, what happens when new PrEN standards become harmonized and published in the O.J.? Will the manufacturer be expected to stop all shipment or is there an official body who will allow manufacturers a certain grace period to bring their products into compliance with the new requirements? I ask this question because I have never seen any grace period allotted when the European Commission publishes an update adding more and more harmonized standards to the Directive. 4. Rhetorical Question (I think): Which route opens up more product liability to manufacturers, standards route or essential requirements route? I would really appreciate any feedback, ESPECIALLY IF THE RESPONSE IS BACKED BY A PUBLISHED POSITION FROM AN OFFICIAL EUROPEAN SOURCE (SUCH AS THE EUROPEAN COMMISSION OR EUROPEAN COMPETENT AUTHORITIES). Best Regards. Tin
