CE marking and EU product compliance: a practical guide

3. From market placement to commissioning: national statutory requirements

An important distinction applies throughout the CE marking process: CE marking covers the placing on the market of a product — it does not automatically authorise its putting into service. These are two legally distinct steps, and both must be addressed when planning market entry.

For many industrial installations — pressure systems, energy equipment or complex machinery — additional statutory requirements apply at the point of installation and commissioning. These obligations are country-specific and may involve notification to local authorities, mandatory third-party inspections or formal operational approvals before the equipment can be put into service. They exist independently of the CE marking process and vary significantly across EU member states.

4. Declaration vs. certification: what’s the difference?

One of the most common points of confusion in CE marking concerns the distinction between self-declaration and third-party certification. The applicable route depends on the product category and the risk level defined by the relevant EU directive or regulation.

Regardless of the specific pathway, manufacturers remain responsible for ensuring that technical documentation is complete, consistent and available for review by market surveillance authorities. The Technical File must demonstrate how the product complies with applicable requirements and may include risk assessments, test results, design documentation and references to applied standards.

The role of harmonised European standards varies by directive. Under the Construction Products Regulation (CPR), application of harmonised standards is mandatory. Under the Machinery Directive, it is strongly recommended, as it provides a presumption of conformity with the essential requirements. Under the Pressure Equipment Directive (PED), alternative technical solutions are widely accepted, making harmonised standards less prescriptive in practice. Manufacturers should verify the specific status of harmonised standards under each applicable directive before defining their compliance approach.

6. Declaration process (self-declaration route)

When no Notified Body is required, the manufacturer follows the self-declaration route:

1. Identify all applicable EU directives and regulations for the product.
2. Apply relevant harmonised European standards to establish presumption of conformity.
3. Conduct a documented risk assessment covering all identified hazards.
4. Compile the Technical File: design documentation, test reports, risk analysis, instructions for use.
5. Issue the EU Declaration of Conformity, signed by an authorised representative.
6. Affix the CE mark to the product before placing it on the market.

Technical documentation must be kept available for at least 10 years after the last product is placed on the market. Market surveillance authorities may request it at any time.

7. Certification process (notified body route)

For higher-risk product categories, or where directives explicitly require it, an independent Notified Body (NoBo) must be involved before the CE mark can be affixed. The process typically follows these steps:

1. Identify the applicable module(s) for conformity assessment (e.g. type examination, full quality assurance).
2. Select an accredited Notified Body registered for the relevant directive and product category.
3. Submit technical documentation and product samples for examination.
4. NoBo conducts review, testing and/or audit of the manufacturing process.
5. Upon successful assessment, the NoBo issues the relevant conformity certificate in accordance with the applicable assessment module.
6. Manufacturer issues the EU Declaration of Conformity referencing the NoBo certificate.
7. CE mark is affixed, accompanied by the NoBo’s identification number.

About SGS:

SGS is the world’s leading Testing, Inspection and Certification company. It operates a network of over 2,500 laboratories and business facilities across 115 countries, supported by a team of over 100,000 dedicated professionals. With more than 145 years of service excellence, SGS combines the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, compliance and sustainability. 

The brand promise – when you need to be sure – underscores its commitment to trust, integrity and reliability, enabling businesses to thrive with confidence. The company proudly delivers its expert services through the SGS name and a portfolio of trusted specialized brands, including Applied Technical Services, Brightsight, Bluesign and Nutrasource. 

SGS is publicly traded on the SIX Swiss Exchange under the ticker symbol SGSN (ISIN CH1256740924, Reuters SGSN.S, Bloomberg SGSN SW). 

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