CE Technical File: Module-Based Templates and Compliance Guide

CE Technical File: Importance of Module-Based Templates

The CE Technical File is the most critical document proving that a product placed on the European Union market is safe, of high quality, and compliant with applicable legislation. Whether the product is a simple household electrical appliance or a high-risk medical device, if the file is incomplete, the product cannot enter the market. Therefore, the technical file is not just a formal requirement but also a safety manual that governs the product lifecycle.

The templates used to prepare the file vary depending on the applicable conformity assessment module. For low-risk products, the manufacturer’s declaration may suffice, while for high-risk products, a Notified Body must be involved. Thus, the file structure is not a “one-size-fits-all” model but must be tailored according to the product’s features, risk level, and legal requirements.

A typical CE Technical File includes product description, risk analysis, test reports, Declaration of Conformity, labeling information, user manual, and a maintenance/update plan. Preparing these elements in full is essential not only for legal compliance but also for building customer trust and protecting brand reputation.

Selection of Applicable Directives/Regulations

One of the most critical steps in preparing a technical file is choosing the correct directive or regulation. The European Union has established different legal frameworks for different product categories. Selecting the wrong directive invalidates the entire file and undermines the legal basis of the CE marking.

For example, a household electrical appliance may only fall under the Low Voltage Directive (2014/35/EU). However, if the same device includes wireless functionality, it also falls under the Radio Equipment Directive (2014/53/EU). If the product is intended for medical purposes, the Medical Devices Regulation (2017/745/EU MDR) applies. Therefore, the product’s design features, intended use, and target market must be carefully analyzed.

Key criteria when selecting directives include:

• Product category: Machinery, electrical device, toy, medical device, construction product, etc.
• Function and intended use: Household, industrial, professional use.
• Risk level: Low-risk (e.g., simple appliances) – high-risk (e.g., surgical implants).
• Additional features: Wireless connectivity, chemical content, high pressure, explosive atmosphere.

In some cases, more than one directive may apply to the same product. In this case, the manufacturer must comply with the requirements of each directive separately.

Risk Analysis: EN ISO 12100 Approach and Implementation Steps

The EN ISO 12100 standard is one of the most comprehensive frameworks for product safety. It describes the systematic steps of hazard identification, risk assessment, and risk reduction. In preparing the CE Technical File, especially in machinery safety, the correct application of this approach is mandatory.

1) Scope and Assumptions

Before starting risk analysis, the product’s intended use must be clearly defined:

• Intended use: The primary functions for which the product is designed.
• User profile: Professional operator, consumer, technician, child.
• Use environment: Home, industrial facility, outdoor, medical environment.
• Maintenance and servicing scenarios: Cleaning, part replacement, software updates.
• Transportation and disposal: Logistics, storage, end-of-life disposal.

2) Hazard Identification

Typical hazards classified under the standard include:

• Mechanical hazards: Crushing, cutting, entrapment, falling.
• Electrical hazards: Electric shock, sparks, short circuit.
• Thermal hazards: Burns, high temperature, freezing.
• Noise and vibration: Hearing loss, fatigue, ergonomic issues.
• Chemical hazards: Toxicity, explosive or volatile substances.
• Software errors: Faults in control systems.

3) Risk Assessment

Each hazard is assessed using the following criteria:

• Severity (S): Seriousness of injury (e.g., minor injury, permanent disability, fatality).
• Frequency (F): How often exposure to the hazard occurs.
• Possibility of avoidance (P): The likelihood of the user avoiding the hazard.

4) Risk Reduction

Risk reduction must follow this hierarchy:

1. Elimination by design: Remove hazard sources (e.g., rounding sharp edges).
2. Protective measures: Physical barriers, safety interlocks, emergency stop buttons.
3. Warnings and training: Labels, user manuals, use of PPE.

5) Functional Safety

If the product includes safety-related control systems (e.g., emergency stop, two-hand control, speed limitation), they must be verified in accordance with EN ISO 13849-1/-2 or IEC 62061.

6) Documentation and Traceability

All risk matrices and analysis results must be kept under revision control. Any product modification requires updating the risk analysis. Each risk must be justified as to why it is deemed acceptable.

Testing, Reporting and Notified Body Relationship

One of the most critical parts of the CE Technical File is the set of test reports that prove compliance with relevant regulations and standards. These reports not only support the manufacturer’s declaration but also serve as binding evidence for market surveillance authorities and Notified Bodies.

Depending on the product’s risk level, testing may be carried out internally by the manufacturer or in accredited independent laboratories. For high-risk products (e.g., pressure vessels, medical devices, or ATEX equipment), independent laboratory testing is mandatory.

1) Test Plan Preparation

A test plan should be prepared before production begins and must include:

• List of applicable standards (e.g., EN 55032 – EMC, EN 60204-1 – electrical safety).
• Number of samples and frequency of tests.
• Test methods, measurement equipment, and tolerance values.
• Acceptance criteria and failure scenarios.

2) Accredited Laboratory Testing

For validity, tests should be conducted in laboratories accredited to ISO/IEC 17025. This ensures acceptance both nationally and internationally. Calibration certificates of measuring instruments should also be included in the technical file.

3) Relationship with the Notified Body

Notified Bodies are independent entities designated by the European Commission. Depending on the product’s risk classification, their involvement may be mandatory. For example, Module B (EU Type Examination) and Module H1 (Full Quality Assurance) require Notified Body participation.

Communication between the manufacturer and the Notified Body must be well-documented, transparent, and regular. Providing complete technical drawings, risk analyses, and quality system documentation helps speed up the process.

Preparation of the Declaration of Conformity (DoC)

The EU Declaration of Conformity (DoC) is the official statement by which the manufacturer assumes full responsibility for the product. It forms the legal foundation of the technical file. The DoC must be prepared before a product is placed on the market and retained for at least 10 years.

Mandatory Elements of the DoC

The Declaration must follow the official format and include the following details:

Points to Consider When Preparing a DoC

• The document should be prepared for each product variant, not just for one product family.
• Date and version number must always be included.
• The DoC should be available in both physical and digital formats.

Clinical and Performance Requirements

Clinical and performance requirements are especially critical for medical devices, in-vitro diagnostic kits, and high-risk products. CE marking must not only demonstrate product safety but also prove that the product is effective for its intended use. For this reason, clinical and performance data form a cornerstone of the conformity assessment process.

1) Clinical Evaluation

Clinical evaluation is the systematic analysis of clinical evidence regarding product safety and performance. According to MDR 2017/745/EU, manufacturers must prove effectiveness using scientific literature, comparative studies, or clinical investigations. Sources include:

• Review of scientific literature
• Clinical experience with similar devices
• Clinical investigations on patients or volunteers
• Observational studies and long-term follow-up data

Findings must be documented in a Clinical Evaluation Report (CER) and added to the technical file.

2) Performance Requirements

Performance testing demonstrates whether the product achieves its intended function. Examples include:

• Medical devices: Functional testing, durability testing, biocompatibility results.
• Diagnostic kits: Sensitivity, specificity, accuracy, repeatability.
• Electrical devices: Performance verification, energy efficiency, lifetime analysis.

Change and Re-Evaluation Process

After a product is placed on the market, any design modification, production process update, or component replacement directly affects the technical file. Therefore, manufacturers must systematically evaluate changes and, if necessary, initiate a re-assessment of conformity.

1) Types of Changes

Changes are typically categorized into three groups:

• Minor changes: Packaging design modifications, cosmetic label updates.
• Medium-level changes: Software updates, replacement of production line equipment, brand substitution of sub-components.
• Major changes: Addition of new functions, change of material used, modification of safety systems.

2) Re-Evaluation Steps

1. Update risk analysis: Assess the impact of changes on the risk matrix.
2. Repeat critical tests: Perform testing again for essential safety and performance features.
3. Inform the Notified Body: In case of major changes, the Notified Body must be informed.
4. Issue a new DoC: After changes, an updated Declaration of Conformity must be prepared.
5. Update labels and manuals: End users must receive updated documentation reflecting the changes.

Labeling, UDI and Traceability

Within the CE Technical File, labeling and especially UDI (Unique Device Identification) for medical devices are key tools ensuring traceability from market placement to end-of-life. A label is not merely a visual mark; it is evidence of compliance, a means of user communication, and an integral part of recall processes.

1) Mandatory Information on Labels

The following elements must be displayed based on the directive, product class, and target market language:

• CE Marking: Reflects conformity declaration. Rules regarding size, visibility, and placement must be followed.
• Product Identification: Model name/code, serial or lot number; production and expiration dates if applicable.
• Manufacturer/Importer Information: Company name, address, and contact details.
• Mandatory Symbols and Warnings: ISO 15223, ISO 7010 and applicable EN pictograms; explanations must be provided in the IFU.
• Language Compliance: Label and IFU must be provided in the official language(s) of the target country.
• IFU Reference: If electronic IFU is used, a QR code or URL must be indicated.

2) UDI System (Medical Devices)

The UDI ensures unique identification and traceability of devices throughout their lifecycle. It consists of two elements: UDI-DI (device identifier) and UDI-PI (production identifier such as lot/serial/date). This information is applied via barcode, 2D code, or RFID.

3) Traceability Records

Products must be traceable from manufacturing to delivery, distribution, and field service with clear data on who, when, and where. This ensures rapid identification of affected batches in case of non-compliance.

Market Surveillance and Recall Management

Once a product is on the market, market surveillance authorities and, when necessary, Notified Bodies may take samples or review documentation. The CE Technical File is the primary reference during such inspections.

1) Scope of Market Surveillance

Typical aspects reviewed during inspections include:

• Label and CE marking: Visibility, placement, compliance with language rules.
• DoC and test reports: Up-to-date status, traceability, and standards references.
• User instructions: Risk warnings, explanation of symbols, servicing guidance.
• Product sample testing: Testing of market samples against harmonized standards.

2) Complaints and Corrective Actions

Each market complaint must be recorded, followed by root cause analysis (e.g., 5 Whys, fishbone diagrams, 5W1H). Subsequently, CAPA (Corrective and Preventive Actions) must be implemented. Critical risks should be reported to authorities proactively.

3) Recall Procedure

If a product poses a hazard, a recall procedure must be initiated quickly, transparently, and traceably:

CE Technical File Maintenance Plan

The CE Technical File is not a static dossier prepared once and forgotten. It is a living, controlled record that must be kept up to date throughout the product lifecycle. A formal maintenance plan ensures continuous compliance with regulatory changes, standard revisions, design updates, and post-market feedback.

1) Purpose of the Maintenance Plan

Through a maintenance plan, the manufacturer can:

• Apply regulatory updates (e.g., new EU regulations or guidance) in a timely manner.
• Track revisions of applicable EN/ISO standards to avoid using outdated versions.
• Properly incorporate product changes (design, components, software) into the file.
• Respond quickly to market surveillance with up-to-date documentation.

2) Revision Cadence

The plan should define clear review frequencies and owners:

• Annual Review: A complete file review at least once per year; if no changes, record “no change”.
• Regulatory Watch: Monitor the EU Official Journal for harmonized standards and guidance on a monthly basis.
• Change-Driven Updates: Trigger immediate revisions after new features, software releases, supplier changes, or process modifications.

3) Digital Archiving and Version Control

Include a digital repository with version control (numbering, change logs, approvals). Ensure that who changed what and when is fully traceable, and maintain read-only archives of superseded versions.

Common Mistakes in Preparing a CE Technical File

Many manufacturers make similar mistakes when preparing technical files. Seemingly small gaps can lead to serious consequences during market surveillance or customs clearance. Below are frequent pitfalls, their outcomes, and practical remedies.

1) Incorrect Directive/Regulation Selection

Assessing a product under the wrong legal framework invalidates the entire conformity process. Hybrid products (e.g., with both electrical and mechanical functions or wireless capabilities) are especially prone to misclassification.

2) Insufficient Risk Analysis

Superficial risk assessments that ignore reasonably foreseeable misuse or maintenance scenarios typically result in major nonconformities.

3) Use of Outdated Standards

Referencing obsolete EN standards can render the product non-compliant. The list of harmonized standards must be monitored continuously.

4) Missing Documentation

Absent test reports, user instructions, or certificates are among the most common findings and are treated as major nonconformities by authorities and auditors.