Text Box: Standard Wire
Edition 12 – May/June 2006




All medical devices, must have a CE Mark in order to be sold in the European Union.  In this issue we focus on the details of CE marking of medical devices.  We review technical files, Notified Body audits, and the EU’s Medical Device Directives.
What is CE Marking?
The letters "CE " are the abbreviation of the French phrase "Conformité Européene" which literally means "European Conformity".  The term initially used was "EC Mark" and was officially replaced by "CE Marking" in the EU Directive 93/68/EEC in 1993.  CE Marking is required for dozens of product categories ranging from toys and consumer electronics to in-vitro diagnostics and medical devices. For medical device manufacturers seeking to sell product within the European Union, obtaining a CE mark for their devices is an essential and practical business strategy.  The CE Mark is the “Trade Passport to Europe”.  Products with a CE mark allows a business to sell its marked products anywhere within the 28 countries of the EFTA and the EU.  For the medical device manufacturer, the CE mark allows the customer to identify those products that have met or exceeded the EU’s Medical Device Directives (MDD) for safety and efficacy.  For medical devices, the CE mark in the EU serves the same purpose as FDA approval of a medical device in the United States.  CE Marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety, and environmental protection legislation, put in practice by many of the Product Directives.
Petitioning companies prepare a Technical File specific to the device or family of devices that they intend to market.  The Technical File holds information that verifies that the testing was conducted properly and that the product complies with applicable standards.   The company submits the technical file to a Notified Body.  This is an organization that has been nominated by a Member Government and has been notified by the European Commission.  The Notified Body is fundamentally an EU-approved organization that checks for conformity with essential requirements through audits of process and documentation at critical stages of product development and review.  The Technical File contains the design, manufacturing, verification, validation specifications, and criteria need to demonstrate the safety and efficacy of the device.  Safety is determined by providing evidence that the device has met the planned requirements for bio-compatibility, design specifications, shelf life dating, and proper labeling.  Efficacy is evidenced through those records that demonstrate the application and usage of the device under controlled conditions that validate that it meets or exceeds the criteria defined for its intended use.
Concurrent with the documentation of technical specifications for the CE mark, it is also advisable for medical device manufacturers to obtain certification of the quality system to the requirements of ISO 13485:2003.  Although not required to obtain the CE mark, certification to ISO 13485:2003 will ensure that the basic requirements of a full quality assurance system have been met per the MDDs.  The successful implementation of an effective quality system helps to ensure that the manufacturer can consistently produce product per its defined technical specification.
How to obtain CE Marking for my product?
There are a series of steps to obtain the CE Mark which depend on the product classification and the nature of the risks it presents.  The Medical Device Directives (MDD) often use a series of questions about the nature of a product to classify the level of risk and refer to a chart called "Conformity Assessment Procedures".  The chart includes all of the acceptable options available to a manufacturer to certify their product and affix the CE Marking.  The following outlines the key steps:
Determine if any MDDs apply to your product.  You must comply with all MDDs that apply to the product.
Determine the extent to which your product complies with the essential requirements for design and manufacturing in the applicable directive(s).
Choose the conformity assessment procedure from the options or modules indicated by the MDD for your product.  The modules available for the Conformity Assessment Procedures are:
Module A:      internal production control
Module Aa:    intervention of a Notified Body
Module B:      EC type-examination
Module C:      conformity to type
Module D:      production quality assurance
Module E:      product quality assurance
Module F:       product verification
Module G:      unit verification
Module H:      full quality assurance
Minimal Risk
Options for products with minimal risk include self certification where the manufacturer prepares a Declaration of Conformity and affixes the CE Marking to their own product.
Greater Risks
Many directives require products/systems with greater risks to be independently certified; this must be done by a "Notified Body".  Notified bodies serve as independent test labs and perform the steps called out by directives.  They must have the necessary qualifications to meet the testing requirements set forth in the directives.  Notified bodies may be a private sector organization or a government agency.  Manufacturers may choose a notified body in any member state of the European Union.  Lists of notified bodies are published by the European Commission in the Official Journal of the European Communities.  A Notified Body is usually able to offer some of the services required:
product testing
type examination certificate issue
Technical File and design dossier evaluation
surveillance of product and quality system
identification of standards
When the Product(s) Requires Certification
The key steps are as follows:
Select the applicable product standards and test methods for your product
Select a Notified Body
Establish an Authorized Representative in the EU for your product.  Some directives require that a manufacturer designate an authorized representative within the European Union to produce technical documentation called the Technical File.  The CE Marking itself is not meant to provide details about the product to Surveillance Authorities.
Prepare a Declaration of Conformity.  This Declaration must contain information adequate for tracing the product back to the manufacturer or the authorized representative in the European Union.  It may include a list the directives and standards that your product conforms to, product identification, the manufacturer's name, address and signature.
Register your product in EU.  Many products, for instance, Class I Medical Devices, are required to be registered in the EU and get a Certificate of Registration.  Without this Certificate of Registration, the products are NOT allowed to be affixed with the CE Marking and be placed on the market.
Affix the CE Marking to your product.   There are specific rules to adhere to for the CE Marking.  These rules address the size and location of the Marking; affixing the CE Marking to products, packaging and material or documents shipped with the product; and specific limitations on when and who is permitted to affix the CE Marking.
Other International Standards
While CE Marking is particularly designed to facilitate development of a single European market, this is also part of a greater worldwide move toward harmonized standards that increasingly lower technical barriers to trade by standardizing safety and quality requirements worldwide.  Two other international quality marks that fall under the standards harmonization includes, Canada’s CMDCAS and China’s CCC.
The Standards Council of Canada developed the quality requirements for medical device manufacturers within Canada.  Registration bodies qualified under the Canadian Medical Devices Conformity Assessment System (CMDCAS) program must demonstrate conformity with these requirements before issuing CAN/CSA or ISO 13485:2003 registration certificates.  For all practical purposes, a company must be ISO 13485 certified to be registered under the CMDCAS program.
Effective on August 1, 2003, the China Compulsory Certification mark (CCC Mark) is required for a wide range of manufactured products being exported to or sold in the People’s Republic of China.  The CCC Mark is required for products in 19 groups divided into totally 132 product categories.  China integrated its two compulsory inspection systems, one to check contents of products for import and export, and the other for quality control, into a single procedure as part of its commitment for entry into the World Trade Organization.  Since May 2002, the two symbols, namely "CCIB" (Safety Mark, introduced in 1989 and required for products in 47 product categories) and "CCEE" (also known as "Great Wall" Mark, for electrical commodities in 7 product categories), have be unified and replaced by the symbol "CCC" 
How to Fast Track CE Marking
Vintara is the leading provider of fully automated, web-based enterprise quality and process management solutions and services within the international accredited standard environments of ISO13485:2003.  Incorporating internationally recognized current best manufacturing practices, our software’s functionality and innovative technology crosses all quality and process standards to deliver the solutions that manage and administer quality, content, documents, and processes to meet international standards and requirements for medical device manufacturing.  Vintara enables the enterprise, regardless of its classification, to meet the regulations for quality, safety of use, and fit of purpose by electronically managing the design, purchase, labeling, storing, packaging, installation, and servicing of medical devices in accordance with international standards and best practices.
 Contact Steve Anderson at sanderson@vintara.com or (510) 808- 2562 or
Visit at ISO13.vintara.com
The Connection between Standards, Compliance & Medical Technology