How an inspection usually begins
In product safety, it rarely starts with an inspector at the door. More often, there is a letter or an email with a request for documents and a deadline for submission. Sometimes the trigger is a report, sometimes a random check, and sometimes a product that has attracted attention elsewhere in Europe.
That request is not an optional inquiry. The Market Surveillance Regulation empowers authorities to order economic operators to provide documents and data. Failing to respond does not make the case smaller; it only makes it more unfavorable.
At the same time, a request is not yet an accusation. In many cases, the regulator simply wants to determine whether the file exists and if it is correct. Those who deliver quickly and completely are usually finished quickly.
What the regulator may request
The powers are set out in Article 14 of the Market Surveillance Regulation. They go beyond just documents. The authority may also request data about your supply chain, your distribution network, the quantities on the market, and other models with the same technical characteristics.
- Documents and data. Everything concerning the conformity and technical aspects of the product, regardless of where it is stored. Access to embedded software is also included when necessary to assess conformity.
- Supply chain data. From whom you source the product, to whom you supply it, how much is on the market, and which related models have the same characteristics.
- On-site inspections. Unannounced, with the power to enter business premises, sites, and means of transport.
- Purchasing samples. Explicitly also under a false identity, for inspection and dismantling.
- Online content. In the event of a serious risk, the removal of content from an online interface may be ordered. A mandatory warning for end users is also among the possibilities.
The latter two surprise entrepreneurs most often. A test purchase does not have to be recognizable as such. And the path to your webshop does not only run through you, but also through your platform.
What you must be able to provide within a week
In practice, it comes down to four items: the declaration of conformity, the technical file including the risk assessment, the test reports stating the standards applied, plus the data on origin and distribution for the exact part number to which the request relates.
It is important that these documents belong together. A file in which the type number on the test report differs from the number on the declaration raises more questions than a missing document. Therefore, check the consistency first and only then the completeness.
If you cannot provide everything within the deadline, report this in a timely manner and indicate what is being provided and when the rest will follow. Silence is almost always interpreted unfavorably.
A folder with two hundred files reads as an inability to show that things are correct. Provide the requested documents, in the requested order, with a line for each document stating what it demonstrates. This saves questions and saves time.
Is there a request from the regulator?
Briefly let us know what is being requested and which product it concerns. We respond within 24 hours on business days.
Which measures may follow
The authority may order you to take appropriate measures to end the non-compliance. If this does not happen or if the risk persists, it may take corrective action itself. It may prohibit or restrict the offering of the product. It may also have it withdrawn from the market or recalled.
So there is a sequence. First, you are given the chance to resolve it yourself. That opportunity is worth more than companies usually estimate, because a self-executed correction is manageable, whereas an imposed recall is not.
In addition, sanctions may be imposed. Exactly what these look like is determined by the national law of the Member State where the infringement occurs.
Who pays the costs of surveillance
This point is rarely mentioned. Article 15 of the Market Surveillance Regulation allows Member States to permit their authorities to recover the costs of activities related to non-compliance from the economic operator concerned. This includes the costs of testing, measures taken, and storage.
Whether and how a Member State uses this option varies. The point is the calculation involved: for a product that turns out not to comply, the laboratory costs of the investigation may end up with you, on top of the damage to your stock and your sales.
What you should avoid doing
Most damage in these processes is caused not by the product but by the reaction to it. Documents created after the fact, answers that evade the question, and declarations that do not match what is in the store exacerbate the problem instead of solving it.
- Backdating documents. An experienced inspector will recognize a file that was prepared after the request. It is better to explicitly state that you are now supplementing the file and when that will be completed.
- Referring to the supplier. If you place the product on the market under your own name, you are the point of contact. Your supplier is your source, not your substitute.
- Remaining silent until the deadline expires. An interim message with a realistic schedule is almost always better than a complete package delivered late.
- Resolving only the single item. If one product is questioned, related models often follow. The regulation mentions this possibility explicitly.
What you should do today
If there is a request, start by reading exactly what is being asked and which part numbers it concerns. Then collect the four core documents for those numbers and check if they belong together. Appoint one person to maintain contact with the regulator.
- Note the deadline and the exact question. Answer the question as it is written, not the question you expected.
- Place the declaration, the file, and the test reports side by side and check if the type numbers match.
- Identify which related models have the same technical characteristics and assess them immediately.
- Appoint one point of contact and keep all correspondence in one place.
- Confirm receipt of the request, even if you do not yet have the documents complete.
There is a request. Now what?
We assess what is being requested, check your file for consistency, and draft the response. This also applies to the related part numbers that follow.
Contact us