The first article in a six part series on CE marking
A Manufacturers Guide to CE Marking
The formation of the European Union (EU) in the 1990s resulted in one of the largest single free trade markets in the world.
Products that were once restricted within the boarders and regulations of a single country could now be transported and sold throughout the entire EU (currently 27 member states). To achieve this level of free trade, a common set of product standards and regulations were established. The introduction of CE (Conformité Européenne) marking became the EU's method of ensuring uniform product conformity and consumer safety across all its member states. Compliance with the CE marking requirements is an essential step for any manufacturer seeking to market and sell their products within the European Union region.
The basic principle of EU harmonisation legislation is that irrespective of the origin of the products, they need to be compliant with the applicable Union harmonisation legislation if they are made available on the Union market. Products manufactured in the EU and products from non-EU countries are treated alike. (1)
Understanding EU Directives and Standards
To understand the CE marking process, you first need to understand harmonized rules that make the marking process possible. These rules are set forth in laws called directives. An EU directive is a type of legislation used by the European Union to establish common requirements for health, safety, and environmental protection across member states. Directives set the goals that member states must achieve but leave flexibility for each state to define how those goals will be achieved.
Often, the steps required to demonstrate compliance with a directive are complicated and need a standardized method of assessment. European harmonized standards were created to establish the minimum technical requirements needed to demonstrate compliance with established legislation. Manufacturers or conformance assessment bodies use these standards to evaluate products for compliance.
Steps to CE Marking
The manufacturer bears the responsible for a conformity assessment of the product. The complexity of the assessment process depends on the product, however there are several key steps every manufacturer needs to perform before applying the CE mark:
Identify the EU directives for health, safety, and environmental protection that are applicable to your product.
Identify the applicable harmonized standards that provide the product requirements necessary to show compliance with the directives.
Perform a conformity assessment to demonstrate your product's compliance with the requirements.
Compile a technical file with all data and test reports necessary to document product compliance with the requirements.
Prepare an EU Declaration of Conformity, formally declaring that your product complies with the directives.
Affix the CE mark to your product.
Identifying Applicable Directives and Standards
Identifying EU directives and standards applicable to your product can be a difficult process and often requires expert input based on your specific product design.
A product example for Identifying applicable EU directives and standards can be found in Unlocking the European Market: Navigating Directives and Standards for Your Product. In addition to this article, you may want to investigate the following resources to determine applicable directives and standards for your product:
Individual Product Research:
Europa.EU is an official website of the European Union containing information on many topics, including the full text of directives. The Harmonized Standards section contains a list of EU directives with a link to associated standards. With specific understanding of the product and the health, safety, and environmental rules, appropriate standards can be identified for CE assessment.
Consult a Notified Body:
Notified Bodies are conformity assessment organizations authorized by EU member states to assess product compliance with relevant directives. Consulting a Notified Body experienced with your product type can provide specific guidance on applicable directives and standards. The New Approach Notified and Designated Organizations (NANDO) website can be used to search for appropriate Notified Body in your area.
Seek Help from a Consultant:
A product regulatory consultant can assist you in navigating the complexities of EU regulations and help to identify the directives associated with your product and the applicable standards for assessing compliance.
Conformity Assessment
Conformity assessment involves evaluating your product to demonstrate compliance with applicable directives and generally follows the following process:
Identify the areas of each directive applicable to the product and the methods that will be used to show conformity. Conformity often involves the identification and reduction of risk as part of a formal Risk Assessment.
If conformity will be shown using a standard, identify each area criteria for evaluation applicable to the product.
Perform all applicable identified tests and measurements. Records of the tests and measurements must be kept and will become part of the official technical file.
For detailed information on assessing product risk, see 'Unlocking the European Market: The CE Risk Assessment'.
The Technical File
The product technical file is a critical component of the CE marking process. It completely documents how your product meets the requirements for all applicable directives. The technical file serves as a vital record for regulatory authorities, demonstrating that you've taken the necessary steps to ensure your product meets EU safety and performance standards. It's also valuable for your own organization, providing a historical record of the product's development and regulatory compliance.
There is no specific format for a CE technical file, however it should be well organized and easy for authorities to navigate. Here is an example of the CE technical file contents, the specific content requirements may vary depending on the applicable directive and the risk classification of your product.
In general, there are five general classifications of essential content, divided into the following 'frameworks':
User Information: Clear and concise user manual with safety instructions and troubleshooting guidance.
Design and Manufacturing: Design calculations, drawings, material specifications, process flow diagrams, and quality control procedures.
Risk Assessment: Detailed hazard analysis, risk assessment matrix, risk reduction measures, and residual risk evaluation.
General Safety and Performance Requirements (GSPR): Test reports for electrical safety, EMC, and mechanical safety; calculations for structural integrity and airflow; documentation of risk reduction measures.
Conformity Assessment: Copies of certificates, test reports, and the declaration of conformity.
For more detailed information on the product CE Technical File, see 'Unlocking the European Market: The CE Technical File'.
EU Declaration of Conformity
The EU Declaration of Conformity (DoC) is a formal document issued by the manufacturer (or authorized representative) declaring that a product complies with the relevant EU directives and requirements. By issuing the DoC, the manufacturer assumes full responsibility for the product's compliance with EU regulations.
There is no specific format for an EU DoC, however the following key elements should be included:
Identification of the Declaration:
This section specifies the document as an EU Declaration of Conformity and assigns it a unique reference for traceability purposes.
Issuer Information:
This part identifies the manufacturer or authorized representative issuing the declaration. It includes their name, registered address, and contact details.
Product Identification:
The DoC clearly describes the product it pertains to. This includes details like the product name, model number, type, and any relevant serial numbers.
Applicable Directives and Standards:
This section lists the specific EU directive(s) and harmonized standards with which the product claims compliance.
Conformity Assessment Procedure:
The DoC specifies the conformity assessment procedure followed to demonstrate the product's compliance. This may reference internal production control, involvement of a Notified Body, or a combination of procedures. The level of detail required for the conformity assessment statement depends on the risk classification of the product, as defined by the relevant EU directive.
Signatory Information:
The authorized signatory representing the manufacturer or authorized representative must sign the DoC. This signature signifies their acceptance of legal responsibility for the product's compliance.
Date of Issue:
The date the DoC is issued is recorded in this section.
Additional Considerations:
The DoC must be drawn up in an official language of the European Union.
The manufacturer or authorized representative is legally obligated to keep a copy of the DoC readily available for authorities for at least 10 years after the last product unit is placed on the market.
The DoC itself is not a complex document, typically spanning a single page. However, it represents the culmination of the entire CE marking process. In essence, the EU Declaration of Conformity serves as a statement to regulatory bodies and consumers that your product has undergone the necessary conformity assessment procedures and meets the safety, health, and environmental requirements established by the relevant EU directives.
Affixing the CE Mark
Placing the CE mark on your product demonstrates that your product complies with the relevant EU directives and unlocks access to the European Economic Area. In most cases, the CE mark is affixed by the manufacturer before the product is placed on the EU market. The manufacturer can appoint an authorized representative based in the EU to affix the marking on their behalf. This representative must have a mandate from the manufacturer to act on their behalf for CE marking purposes.
The following marking requirements are required by most directives:
Visibility and Legibility:
The CE marking itself must be clearly visible, legible, and indelible. It should be permanently affixed to the product or its data plate in a location readily accessible for inspection by authorities or consumers.
Size and Proportion:
The marking's size and proportions must be appropriate to the product's size and surface. There's no minimum size requirement, but it should be large enough to be easily seen and read.
Specific Requirements for Certain Products:
Some directives might have additional specifications regarding the marking's format. For example, products of high category risk require assessment by a notified body and will be issued a registration number. These products are required to include the registration number with the CE marking.
Where to Start
CE marking can be a difficult and confusing process. The 'Blue Guide' (1) on the implementation of EU product rules 2022 is a comprehensive resource for understanding the general process and principals involved in CE marking. The guide clarifies the general obligations of manufacturers when placing products on the EU market, including understanding the conformity assessment procedures, and the importance of maintaining technical documentation.
References:
Striper Solutions LLC, Your Regulatory Partner
With over 30 years development experience and more than a decade providing consulting services, Striper Solutions has demonstrated a commitment to excellence and integrity in developing new products. Embracing a shift to regulatory compliance allows us to focus on a critical area of product development with the dedication and quality our customers need.
See more at www.striperllc.com
Comments