CE compliance from day one: assurance of quality, safety and legal peace of mind

CE marking is still too often seen as a box to tick at the very end of a project. But that is precisely where things go wrong. When commissioning approaches and the question arises about who is responsible for the conformity of the entire installation, the answers often turn out to be unclear or even absent. At Sweco, CE marking and the Technical Construction File (TCF) are an integral part of a high‑quality design and construction process from day one. That is where compliance, technical choices and commercial interests come together.

CE in multidisciplinary projects: an underexposed topic

Gerard sees it every day: project meetings focus mainly on design, planning and budget, while CE legislation often remains out of sight. “Operators typically rely on the manufacturer of machines or components to provide conformity documents. That’s necessary, but it doesn’t come close to covering everything when you combine multiple machines and installation parts into a single functioning installation.”

This leads to a crucial question that is rarely asked: Who is legally the manufacturer of the complete installation? As long as this remains unclear, risks, delays and potentially costly corrections will arise.

Many companies become manufacturers without realising it

Gerard explains that you become a manufacturer much sooner than you might think. “When you integrate machines, pipework or installation components into one process line or retrofit, you create a new whole. Legally, you become the manufacturer under the relevant directives, such as the Machinery Regulation (EU) 2023/1230 or the PED for pressure equipment.”

This means you are responsible for the risk assessment, technical documentation and the EU Declaration of Conformity. That responsibility does not automatically remain with the original machine manufacturers, but shifts to the party who assembles the whole.

Responsibility and liability

As a manufacturer, you must be able to demonstrate that the entire system complies with all relevant directives. That goes far beyond machinery legislation alone. Depending on your installation, you may also need to comply with:

• PED for pressure equipment
• ATEX for explosive atmospheres
• Low Voltage Directive
• EMC Directive

For all of these, you need a complete and up‑to‑date Technical Construction File. Gerard warns: “Without such a file, it becomes very difficult to demonstrate compliance during inspections, audits or incident investigations.”

Where do things go wrong today?

According to Gerard, timing is the biggest issue. “Many companies still view CE as a final step. They build, test and commission, and only then ask who the manufacturer is. That leads to retroactive puzzle work: what happened, who did what and according to which standards? It costs time, money and creates legal uncertainty.”

Problems also arise in design and procurement phases. “The right priorities are not set. Documentation is incomplete, risk assessments are missing and the technical file is only compiled at the end. While it should grow step by step throughout the project.”