New version of the Blue Guide 2014. What is new?

img_news_bluguideIn April 2014, the European Commission finally published the revised Blue Guide on the implementation of EU products rules (The “Blue Guide”). This updated version of the Blue Guide reflects the modernization and harmonization of the EU legislative framework for marketing of products.

The Concept and Objectives of the revision

The New Blue Guide updates the previous edition of the Blue Guide (Guide to the implementation of the directives based on the New Approach and the Global Approach), published in 2000. Since then, as it is stated in the new Blue Guide, it has become one of the main reference documents explaining how to implement the legislation based on the New Approach, now covered by the so-called New Legislative Framework (NLF).

The need to revise the Blue book was evident since it was necessary to ensure a common understanding on the implementation of the NLF and to cover new developments such us the modifications introduced by the Lisbon Treaty in 2009. Therefore, the updated version of Blue Guide aims at including and explaining the different elements of the NLF, especially placing of various products on the EU market, and also at ensuring its uniform and coherent application across the different product sectors and throughout the Single Market.

Although the Blue Guide is intended as a guidance document and is not legally binding, it is immensely useful document for interpretation of legislation aimed at such particular industries asmedical devices,cosmetics,electrical equipment, toys, personal protective equipment and other consumer products.

The present Blue Guide is addressed to the Member States and others who need to be informed of the provisions designed to ensure the free circulation of products as well as a high level of protection within the EU (e.g. standardisation bodies, manufacturers, importers, distributors, conformity assessment bodies, authorized representatives and trade unions).

Scope of the New Blue Guide

The revised Blue Guide covers non-food and non-agricultural products referred to as industrial products or products whether for use by consumers or professionals. The New Blue Guide also includes an updated list of Union Harmonisation Legislation falling within its scope. It now clearly states that it does not attempt to cover the Directive on General Product Safety, Union legislation on motor vehicles, construction products, REACH and chemicals. Furthermore, the Blue Guide does not discuss the applicable rules for food or agricultural products.

The Blue Guide discusses the following topics related to placing a product on the EU market:

  • The actors in the product supply chain and their obligations. These obligations apply to the manufacturer, the authorized representative, the importer and the distributor of the product.
  • Essential product requirements. The Blue Guide examines the role of harmonised standards, traceability requirements, technical documentation, EU Declarations of Conformity, CE marking etc.
  • Conformity assessment.  The Blue Guide discusses the concept and structure of conformity assessment process, the role and responsibilities of conformity assessment bodies and notified bodies.
  • Accreditation. This includes information on the accreditation of conformity assessment bodies both at an EU level and internationally.
  • Market Surveillance. The New Blue Guide emphasize the importance of market surveillance, outlines the market surveillance activities as well as the responsibilities of the Member States.

 

What was updated in the new Blue Guide?

According to the objectives of revision, the new version of Blue Guide includes new chapters, for example on the obligations of economic operators or accreditation and completely revised chapters such as those on standardisation or market surveillance.

The New Blue Guide states that the Union Harmonisation Legislation applies when a product is “placed on the market” (i.e. when the product is made available for the first time on the EU market), as well as to any subsequent operation which constitutes making available until it reaches the end-user. It should be noted that the aforementioned legislation applies to all forms of selling and only to finished products.

Moreover, it applies both to newly manufactured products and to used and second-hand products imported from third countries when these products enter the EU market for the first time. The Guide also clarifies the definitions of the different actors in the supply chain (e.g.manufacturers, authorized representatives, importers, distributors and end-users) and their related obligations. Among other updates, relevant changes relate to “distributors” whose obligations are now clearly emphasized.

  • Product requirements:

–          The New Blue Guide includes clarification of “essential requirements” and “harmonised standards”, with reference to the definitions included in Regulation (EU) No 1025/2012;

–          The New Blue Guide now lays down the procedure leading to a harmonised standard by creating a presumption of conformity;

–          Whereas the Old Blue Guide required manufacturers or authorised representatives to draw up an EU Declaration of Conformity in one of the official languages of the EU, the New Blue Guide now requires a translation into the language(s) required by the Member State in which the product is placed or made available on the EU market.

  • Conformity assessment and accreditation:

–          The New Blue Guide specifies that, under Union Harmonisation Legislation, the conformity assessment procedures consist of one or two conformity assessment modules. The legislator selects the most appropriate one(s) from these modules or procedures (which are set out under Decision No 768/2008/EC) to address the specific needs of the relevant sector.

–          The New Blue Guide gives a thorough guidance on the system of accreditation (i.e. attestation by an accreditation body that a conformity assessment body has the technical competence to perform a specific conformity assessment activity).

  • Market surveillance:

–          The New Blue Guide not only outlines market surveillance activities, but also gives extensive guidance on the responsibilities of the Member States;

–          Appropriate market surveillance mechanisms.  This is a new Chapter in the revised Blue Guide which provides guidance, including guidance on market surveillance activities, EU Member State responsibilities, and corrective measures such as recalls and sanctions.  The Blue Guide also discusses the medical devices vigilance system.

Challenging EU regulatory framework after the blue Guide

The aim of the first New Approach directives focused on the elimination of barriers and on the free movement of goods in the single market. Nevertheless, the Blue Guide as non-legally binding instrument serves only as a guidance document, it will hopefully achieve its ambition of developing a more uniform approach. The new Blue Guide is a “living” document, meaning that it will be regularly updated according to the latest regulatory developments.

The New Blue Guide 2014 is available in English on the European Union’s website.

For further information on the Blue Guide 2014, please contact us.

Follow us:
Facebook

Facebook
Google+

http://obelismedical.net/blue_guide_2014_what_is_new/
YouTube

YouTube
LinkedIn

RSS
in Industry News Active Implantable Medical Devices, Industry News In-Vitro Diagnosis, Industry News Medical Devices, News