The EU CE Marking Process: From Directive Identification to Technical File

CE marking is a declaration, not a badge

The letters CE are not issued by the European Union. They are affixed by the manufacturer as a declaration that the product meets every applicable EU harmonisation rule. There is no central authority that grants a CE mark, and any service that offers to "get you CE certified" in exchange for a fee is selling you either a notified body assessment, which is sometimes required, or nothing at all.

The legal obligation sits with the manufacturer, or with the importer when the manufacturer is outside the Union. That is why the first step is not testing — it is legal research.

Step 1: identify the applicable legislation

A product may fall under several directives and regulations at once. A machine with a radio module and a battery sits under the Machinery Regulation, the Radio Equipment Directive, the Low Voltage Directive and the Battery Regulation simultaneously, and each brings its own essential requirements and its own conformity assessment route.

Build a legislation map before touching a test laboratory. List every rule with its scope test, its essential requirements, its conformity assessment options, and whether it requires a notified body. Missing one applicable rule is the most common and most expensive CE marking error.

Step 2: classify risk and pick the assessment module

Each directive offers one or more conformity assessment procedures, described as modules in Decision 768/2008/EC. The choice is driven by risk class. Internal production control, module A, is sufficient for low-risk products and requires no third party. Higher-risk categories — certain machinery, medical devices, pressure equipment — require a notified body and a module such as B plus C, or H.

Confirm the notified body's scope in the NANDO database before contracting. A body outside its designated scope issues an opinion with no legal value.

Step 3: build the technical file

The technical file is the substance of the claim. It typically contains the design drawings, the risk assessment, the harmonised standards applied, the test reports, the instructions and safety information, and the EU declaration of conformity. It must be retained for ten years after the last unit is placed on the market.

Keep it structured against the essential requirements of each applicable rule. An assessor reads it looking for the link between a requirement, the evidence, and the decision made. A file that is a folder of test reports without that thread invites questions.

Step 4: the declaration and the mark itself

The EU declaration of conformity is a legal document. It names the manufacturer, the product, the legislation applied, the standards used, the notified body where relevant, and the person authorised to sign. Draft it in the language or languages required by the member states where you sell.

The mark itself has geometric requirements. The two letters must have the proportions defined in Regulation (EU) 2019/1020 and, where the product is covered by legislation requiring it, must be at least 5 mm high. Scale it up proportionally; never distort or stretch it. Affix it visibly, legibly and indelibly, on the product or its data plate, and on the packaging where the product cannot carry it.

Where companies actually fail

Market surveillance authorities report the same three failures repeatedly: a technical file that cannot be produced when requested, an applicable directive that was never mapped, and a declaration of conformity referencing a withdrawn standard edition. None of these is a manufacturing defect. All three are process failures that a disciplined file review would catch before a customs hold.