New Approach Directives Bring Noteworthy Clarifications

The New Approach Directives, which often are referred to as CE Marking Directives, are a legislative mechanism that helped the European Union achieve its goal of eliminating barriers of trade between member state countries and creating a single market in Europe. Three documents are incorporated into the New Approach:

  • Council Resolution (May 1985) on New Approach to technical harmonization and standardization
  • Council Resolution (December 1989) on Global Approach Conformity Assessment
  • Council Decision (July 1993) on Modules Conformity Assessment Rules and CE Marking used Technical Harmonization Directives

These directives facilitate the free circulation of products among member states (internal market) while simultaneously protecting consumers within the member states.

Manufacturers that are subject to these directives must meet relevant mandatory Essential Requirements, select an appropriate Conformity Assessment procedure and, once in compliance with the directive, affix the CE Marking to the product, its packaging, or both. Depending on the type and classification of the product, notified body involvement may be required. (In addition, European Norm harmonized standards, published in the Official Journal of European Communities [OJEC], facilitate demonstration of compliance with the Essential Requirements. The topic of conformity assessment for medical devices was discussed in this column in the May issue of Medical Product Outsourcing, available at These New Approach Directives cover a range of products, from recreational watercraft to construction products and, obviously, medical devices.

Background to Revision

The revision of the New Approach Directives began with the European Council of Ministers adopting a resolution (in November 2003) for the European Commission to revise the New Approach. As an adjunct to its activities, the Commission sought public commentary on the revision during the summer of 2006. In February 2007, the Commission formally decided to accept the proposed regulation. The next step is adoption by the European Council and Parliament.

The New Legal Framework

The New Approach Directives were modernized and adopted by the European Council on June 23, 2008. In this second iteration, the directives are billed as the "New Legal Framework," and the two legal texts consist of a "Regulation" and a "Decision." The texts are not official legal documents until they are published in the OJEC, but their publication was imminent as of press time. The Regulation will take effect at the beginning of 2010.

This New Legal Framework has been designed to:

  • Introduce better rules on market surveillance
  • Reinforce rules on requirements for notifications of conformity assessment bodies and increase use of accreditation
  • Clarify the meaning of CE Marking

The text in the revised Regulation and Decision has increased significantly.

The Impact

Medical device manufacturers should be relieved to know that these revisions don't impact many aspects of the medical devices directives. However, one term that has been formally defined in the revised directives is "economic operator."

In the revised directives, economic operators collectively are described as the manufacturer, authorized representative, importer and distributor. The definitions of manufacturer and authorized representative remain consistent with the definitions used in the directives for medical devices. The importer is an entity established in the community who places a product on the market, while a distributor makes a product available on the market and is involved in the supply chain but isn't the manufacturer or importer.

In addition, The Blue Book (or "Vade Mecum"), which contains guidelines on the New Approach and Global Approach, previously had provided guidance on responsibilities of the manufacturer, authorized representative, importer, and distributor. However, this now has been officially described in Annex I of the Decision.

The obligations of the economic operators are formally delineated in the articles of Annex I.

The recitals of the Decision explain that economic operators are responsible for the compliance of products as it relates to their role in the supply chain, and the decision provides a distribution of obligations proportionate to the role of each economic operator in the supply chain. Furthermore, importers are required to ensure that:

  • Products the importer places on the market comply with the relevant requirements
  • The manufacturer has completed the conformity assessment procedures
  • The manufacturer's product marking and documentation are available

Many of the comments about manufacturers were expected - manufacturers' products need to be designed and manufactured to comply with the appropriate legislation; manufacturers need to possess technical documentation and applicable conformity assessment; and information supplied by the manufacturer is written in language understood by the user, as determined by the member state concerned; and so forth.

One expectation enhances the traceability of products: The manufacturers' products must bear a type, batch or serial number, or other element allowing identification; if that is not possible, the information should be included on the packaging or with information accompanying the product. Importers should possess a copy of the manufacturer's Declaration of Conformity and should ensure that if the technical documentation is requested, it be made available to European authorities. In addition, products within the supply chain need to be traceable so an economic operator can provide information on the economic operator who supplied them and on the economic operator to whom they have supplied.

The New Legal Framework clearly places greater responsibility on the economic operators within the supply chain. Medical device manufacturers should possess formal agreements between themselves and the authorized representative, importer and distributors to ensure that each entity is performing its role as described. Greater responsibility now is placed on both the importer and distributor. Thus, manufacturers may find that their importers are beginning to request their technical documentation more often. Member states are charged with levying "penalties for infringements, which may include criminal sanctions for serious infringements" for products that are improperly CE marked. With time, there also will be a revised Blue Book, which will assist with guiding the European Community - economic operators included.

September 2008