Technical regulations and the CE mark question

This is one of the most common practical questions I am asked by manufacturers considering production in Ukraine, and it is usually asked with the wrong assumption behind it.

What the CE mark actually is

Not a certificate issued by an authority. It is a declaration by the manufacturer that the product complies with the applicable European requirements. The manufacturer applies the mark themselves, on their own responsibility, and must hold the technical file that supports it.

Where the product is made is irrelevant to the mark. What matters is that it complies and that the person placing it on the European market can prove so.

Where third-party assessment enters

For higher-risk product categories, the applicable directive requires assessment by a notified body — an organisation designated by a member state. For those categories, the manufacturer cannot self-declare.

This is where the location question genuinely arises: a Ukrainian testing body is not a notified body under European law unless mutual recognition exists. Hence the significance of the conformity assessment agreement discussed elsewhere in this archive.

The practical position

For self-declaration categories, manufacturing in Ukraine presents no obstacle: build the technical file, test to the harmonised standards, declare, mark, and place on the market through an authorised representative established in the Union.

For notified-body categories, budget for assessment inside the Union until recognition is in place, and factor the cost and time into the project rather than discovering it late.

The advice I give

Establish which category your product falls into before anything else. It determines your cost base, your timetable and whether your Ukrainian test data is usable. It is a question with a definite answer and it is answered too late in most projects I have seen.

This is the question I am asked most, and the answer has been the same for years: CE is not a quality badge but the manufacturer's own declaration, and without a technical file behind it, it means nothing. Having worked in conformity assessment I would add that what a market trusts is not the mark itself but who supervises it.