Understanding European Declarations of Conformity or Incorporation

Understanding European Declarations of Conformity or Incorporation
In the wonderful world of medical device regulation, a manufacturer may find it easy to become confused with FDA rules.  When your product moves to the international market, there are new rules that must be followed to get your product to market. 

If you want to sell internationally, you’ll have to understand the difference between certification and marking.  What challenges do they present and what are they used for? Doug Nix does a great job of explaining the concepts in “Understanding European Declarations of Conformity or Incorporation.”

Certification vs. Marking
Nix says the oldest existing system for product safety is the Certification System. For example, you may be familiar with Underwriters Laboratories, a common certifying body.  The lab will test the product, including any aspect of the design related to the safety of the product.  If the product passes all the tests, the certifying laboratory issues the manufacturer a license to put the lab’s mark on the product.  A certificate stating the product’s conformity with the requirements is issued.

The certifying laboratory will also conduct a series of audits at the manufacturing site to ensure that the product continues to meet the safety standards.

CE Mark
Nix provides a brief history of the marking process in the European Union.

“The CE Mark was introduced as a sign that the product met the relevant product safety requirements,“ he writes.  “As part of this, the EU did not want to add unnecessary cost for manufacturers, so rather than implementing a certification system like that used in North America, it was decided to use a “self-declaratory” process for everything except the most hazardous products.”

Manufacturers determined which product safety laws, known as Directives, applied to their products. Safety standards were harmonized under directives.  “Once a manufacturer is satisfied that all necessary safety measures have been used, and has compiled a Technical File for the product, the CE mark can be placed on the product, an EU Declaration issued and the product shipped,” Nix writes.

Nix summarizes the EU Declaration with these points:
  • Should be based on EN ISO/IEC 17050–1 and supported by documentation (e.g., a Technical File) as layed out EN ISO/IEC 17050–2 and the relevant Annexes to the applicable directives.
  • Should state “EU Declaration of Conformity” or “EU Declaration of Incorporation” as appropriate.
  • Must include the relevant statements from the directives (i.e., "a sentence expressly declaring that the machinery fulfils all the relevant provisions of this Directive and where appropriate, a similar sentence declaring the conformity with other Directives and/or relevant provisions with which the machinery complies. These references must be those of the texts published in the Official Journal of the European Union;” and “ a sentence declaring which essential requirements of this Directive are applied and fulfilled and that the relevant technical documentation is compiled in accordance with part B of Annex VII, and, where appropriate, a sentence declaring the conformity of the partly completed machinery with other relevant Directives. These references must be those of the texts published in the Official Journal of the European Union;” (12)
  • Must carry a listing of the relevant directives.
  • May include the manufacturer’s logo, but use of letterhead is unclear.
  • Must include the manufacturer’s information AND the EU Authorized Representative’s information.
  • Should be included as a hard copy with the shipping paperwork.
  • Should be included in the product documentation.
  • May be made available on the company web site (many manufacturers do this).
  • Must include all of the relevant information as laid out in the Annexes to the relevant Directives.

Robyn Barnes, a public relations specialist at MasterControl Inc., writes about the life sciences industry and other regulated environments. Her three decades of marketing and public relations experience include work with USAA, Morrison Knudsen Corp., and KBHome Inc. She holds a bachelor’s degree in journalism and a master’s degree in business from New Mexico State University.