The fourth article in a six part series on CE marking
A Passport to the European Market
The CE technical file demonstrates that a product meets all applicable essential requirements for the CE mark.
The technical file is a comprehensive record of the information showing evidence that a product complies with EU regulations. It demonstrates proof of compliance to regulatory authorities, with appropriate technical design and test data showing compliance to EU directives and standards.
In addition to product information, design calculations, and test results, the technical file documents the risk management performed as part of the product design, ensuring that potential hazards have been identified and mitigated. A well-documented technical file can protect manufacturers from legal liabilities by demonstrating due diligence. A clear and organized technical file streamlines the CE marking process and increases the chances of smooth market entry.
Who Creates the Technical File?
The manufacturer is ultimately responsible for creating and maintaining the technical file. This responsibility extends to ensuring its availability for inspection by regulatory authorities for a specified period after the last product has been placed on the market.
While the manufacturer holds the primary responsibility, there are instances where access to the technical file is necessary for other parties:
Importer: If the product is imported into the EU, the importer must have access to the technical file to ensure compliance.
Authorized Representative: If the manufacturer is located outside the EU, an authorized representative may need access to the technical file to fulfill their obligations.
Notified Body: In cases where a notified body is involved in the conformity assessment, they will require access to the technical file for evaluation.
Regulatory Authorities: These authorities may request access to the technical file during market surveillance activities or in case of incidents.
It's important to note that while others may have access to the technical file, the ultimate responsibility for its creation, maintenance, and availability lies with the manufact
Technical File Organization and Management
There is no specific format for a CE technical file, however it should be well organized and easy for authorities to navigate. Use a logical folder structure that reflects the technical file content. Documents should have unique identifiers for easy reference and consider using a version control system for document and product updates.
It is important to remember that the technical file is a dynamic document. As the product changes or evolves over time, the file must be updated accordingly.
Technical File Structure and Content
The specific contents and structure of a technical file will vary depending on applicable directives and the product risk classification.
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.
Technical File Example
Rather than give long lists of possible technical file content, let's use a specific product example, the enclosed fume hood described in Unlocking the European Market: Navigating Directives and Standards for Your Product. This product has hazards common to many products and the technical file example will be common to most equipment or machinery.
Overview:
This technical file outlines the design, manufacturing, and conformity assessment of an enclosed fume hood for laboratory use. The product is subject to the Machinery Directive, Low Voltage Directive, EMC Directive, and RoHS Directive, and conforms to standards EN 60204-1:2018, EN 61010-1:2010.
Technical File Structure and Contents
1. General Product Information
Product description, including intended use, dimensions, weight, materials.
Technical drawings and schematics.
Product identification (model number, serial number).
Applicable directives and standards.
2. Risk Assessment
Hazard identification (e.g., electrical shock, moving parts, chemical exposure).
Risk analysis (evaluation of risk severity and likelihood).
Risk reduction measures (e.g., safety interlocks, emergency stop).
Residual risk evaluation.
3. Design and Manufacturing
Design calculations and simulations (e.g., structural integrity, airflow).
Manufacturing process description, including quality control measures.
Material specifications and test reports.
Component supplier information.
4. General Safety and Performance Requirements (GSPR)
Machinery Directive:
Safety components (emergency stop, interlocks, etc. if needed).
CE marking and conformity assessment procedure.
Risk assessment documentation.
Technical documentation related to machinery safety (e.g., guarding, accessibility).
Low Voltage Directive:
Electrical safety requirements (e.g., insulation, clearances).
Compliance with EN 61010-1:2010.
Electrical schematics and diagrams.
Test reports for electrical safety.
EMC Directive:
EMC requirements (emissions and immunity).
Compliance with applicable EMC standards.
Test reports for EMC.
RoHS Directive:
Declaration of conformity to RoHS.
Material composition and test reports.
5. Conformity Assessment
Declaration of conformity.
Involved notified bodies (if applicable).
Conformity assessment procedures (e.g., self-certification, type examination).
Certificates and test reports.
6. User Information
User manual, including installation, operation, maintenance, and troubleshooting instructions.
Safety instructions and warnings.
Disposal information.
7. Post-Market Surveillance
Plan for monitoring product performance (if required in specific application).
Complaint handling procedures (if required in specific application).
Adverse event reporting procedures (if required in specific application).
By following the structure shown above and including the essential content, you can create a comprehensive technical file that demonstrates compliance with the required directives and standards for a large range of products.
Retention Period
Most directives specify that the technical file must be kept for a minimum of 10 years after the last unit of a product model has been placed on the market.
However, it's advisable to retain it for a longer period, especially for products with a long lifecycle.
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