- Author: Faith C Beaty
- Keywords: Business Assurance
Valve Magazine, August 2016 – The European Union's (EU) New Legislative Framework (NLF), which was set forth in 2008, has sharpened the focus on importer and distributor responsibilities as they relate to importing or placing CE-marked (European Conformity) products on the market. This focus is reflected in the recasting of several EU directives that affect the valve and equipment industries, including Pressure Equipment Directive (PED) 2014/068/EC and Equipment for Potentially Explosive Atmospheres (ATEX) Directive 2014/034/EC.
Along with product manufacturers, importers and distributors are subject to specific obligations in the context of "market surveillance" (a term used in Europe that means monitoring products to ensure they conform to the law).
Since 1987, more than 27 EU product directives have come into force. These directives have the dual purpose of: 1) ensuring the free movement of goods through technical harmonization (alignment of safety objectives) of entire product sectors; and 2) guaranteeing a high level of protection and safety.
This new way of doing things (which is called the New Approach and Global Approach) was a unique and bold change to previous European methods for issuing product safety regulation. As such, it hasn't been without significant challenges during the implementation.
The New Approach and Global Approach Directives changed the product compliance world by introducing several new regulatory undertakings including:
- Harmonization of safety objectives by all European Economic Area (EEA) member states through risk-based development, rather than prescriptive solutions
- Technical harmonization of product safety through industry-developed product standards
- Recognition of private, third-party conformity assessment bodies (called Notified Bodies) for assessment of higher risk products
- Application of CE Marking on products to identify compliance with EU Directives
- Application of EEA structures for monitoring products placed on the market or put into services in the EEA under the EU Product Directives
Industry trade associations, conformity assessment bodies, national authorities and the EU Commission technical working groups provided feedback. The feedback addressed variations between member states in regards to enforcement, assessment irregularities between notified bodies and inconsistencies in the technical application of EU Directives. In 2008, as result of the EU Commission review, the European parliament adopted two regulations that affect the new approach directives. The primary focus of those rules was to:
- Strengthen the value of CE marking
- Put emphasis on member state control of notified bodies
- Strengthen market surveillance (including defining the roles for different parties)
- Align the conformity assessment modules of the global approach system
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