Most non-EU manufacturers think their AR is doing a full CE assessment – but they’re not (and that could cost you your market access)

When non-EU manufacturers appoint an EU Authorised Representative (AR), a common misunderstanding often arises: the belief that the AR will – or should – conduct a full CE conformity assessment of the product. This misconception can lead to misplaced expectations and potential compliance issues.

Let’s clarify what the AR is legally required to do, what that means in practice, and how 24hour-AR goes beyond the basics to ensure your market access is smooth and safe.

Under Regulation (EU) 2019/1020, which governs market surveillance and compliance of products in the EU, the role of the Authorised Representative is clearly defined.

One of the key responsibilities of the AR is to verify that the EU Declaration of Conformity and the technical documentation exist. In other words, the AR must ensure that the manufacturer has compiled the required documentation, but the regulation does not mandate that the AR checks the content in full detail or performs a full assessment of product conformity.

This is a crucial distinction.

A CE conformity assessment is the responsibility of the manufacturer. It involves determining which directives and regulations apply, selecting and applying conformity assessment procedures, performing risk analyses, and preparing technical documentation that supports the product’s compliance.

The AR’s job is not to repeat or duplicate this work, but to verify that the manufacturer has done it.

The confusion likely stems from the fact that ARs handle technical documentation and communicate with EU authorities. As a result, some manufacturers assume this includes reviewing or approving the compliance itself.

But expecting an AR to carry out a full conformity assessment is like expecting your accountant to also audit your suppliers: related, but outside their scope.

At 24hour-AR, we believe that simply ticking a box isn’t enough – especially with increased market surveillance, growing liability, and the complexity of EU legislation.

While we are not legally required to perform a full CE assessment, we go a step further:

• We assess whether your technical file meets our own stringent internal documentation criteria. This includes checking for completeness, structure, and key compliance elements we know EU authorities may look for.
• We flag obvious compliance gaps or high-risk issues. For example, missing risk assessments, incorrect declarations, or outdated standards.
• We communicate proactively with our customers. If we identify documentation or product risks, we don’t ignore them, but we reach out to collaborate on solutions.
• We help prevent problems before they happen. Our proactive approach reduces the chance of customs delays, market withdrawals, or legal exposure.

We do all of this without overstepping our legal role. The responsibility for product compliance remains with the manufacturer, but we act as a critical compliance partner.

Assuming your AR will perform a full CE review is risky, both legally and practically. You might overlook important gaps in your documentation, thinking someone else has already “approved” it.

Working with a responsible AR like 24hour-AR ensures that:

• Your documentation exists and is fit for scrutiny
• You’re alerted to risks before authorities raise them

You receive support, not just signatures

An Authorised Representative is not a notified body. They do not perform full CE assessments or approve your product, although we can provide support on that when requested. But with the right AR partner, you gain far more than a mailbox in the EU.

At 24hour-AR, we make sure you’re not only compliant on paper, but well-prepared for real-world scrutiny.

Need an AR who does more than the minimum?

Contact us today and let’s talk about compliance done right.