What documents do you need for a notification via the Safety Business Gateway?
If it becomes apparent that a product you have placed on the market could pose a risk, the regulation provides for a duty to notify the supervisory authorities. This happens via the Safety Business Gateway, the European notification point for businesses. In practice, you need three types of documents for that notification: documents that uniquely identify the product, documents that describe the risk, and documents that show what you have already done to mitigate the problem.
The detail where businesses most often run into trouble on this subject is not the notification itself but the identification underlying it. A notification without conclusive type and batch numbers is difficult for a supervisory authority to link to the correct batch of products, and that delays the very process that is meant to be fast. Those who have this detail in order in advance do not need to reconstruct it under time pressure later.
Product identification: the document most often missing
A notification stands or falls on the question of whether a supervisory authority can distinguish the product in question from all other products you sell. This requires the type or model number, the batch or serial number if applicable, the brand name, a product photo and preferably the barcode or EAN code. Without this information, a notification is essentially a signal without an address: the supervisory authority knows that something is going on, but not exactly which items.
This is also the reason why it is wise to record type and batch numbers not only on the label, but also in your own product overview. That overview is precisely what you provide as soon as a notification proves necessary.
Description of the risk
In addition to identification, a notification requires a description of what the problem is: what use or what property of the product could lead to a risk, under what circumstances this occurs, and whether any incidents or complaints are already known about it. A risk analysis that you have already drawn up for your dossier is the first document you turn to for this. If you do not have one, this description must still be drawn up on the spot, and that takes time you would rather not lose at that moment.
What you must already have in place before it is needed
Most of the documents a notification requires are the same documents that are also built up for the regular product dossier: the technical documentation, the risk analysis, an overview of how many units have been sold and in which EU countries, and any correspondence with the supplier or manufacturer about the problem. You are also asked what measures have already been taken, for example stopping sales, adjusting a product page, or informing customers. A complaints register is one of the sources that shows whether a signal stands alone or is structural.
Contact details are also part of a complete notification: not only of your company, but for imported products also of the manufacturer or, where applicable, the responsible person in the EU. Those who do not have this information at hand lose time looking for it at the moment when speed is crucial.
Why this goes faster if the dossier already exists
None of these documents need to be drawn up specifically for a notification; they should all already be part of an ongoing GPSR file. The difference between a company that completes a notification within a day and one that takes days lies rarely in the notification itself, but in whether the underlying documents already existed or still had to be created. This is also why supervisory authorities and industry organisations repeatedly point out that a file is not a formality you set up for appearance's sake, but the material you need as soon as something happens.
What gpsria.eu does and does not do in this regard
We structure the risk analysis and product file so that the data a notification requires is in one place, and we signal weekly whether there are Safety Gate publications in your own product categories. In doing so, we do not make a judgment about the safety of a product and we do not complete a notification on your behalf; for the assessment of a specific risk and for the notification itself, we refer you to specialised partners or to the competent supervisory authority.
Whether you may face this notification obligation for your products depends on the role you hold in the supply chain. in a few questions see which role fits you provides a first indication of this without requiring you to have an account. If you want to go deeper into which documents belong to which obligation, you will find that worked out in the knowledge base with topics per situation. How the system structures the risk analysis and file precisely is explained on the page about how the information is structured, and what a subscription costs for this you can see on the overview of subscriptions.
If you are unsure whether this is relevant for your products, first do the free role check or browse through the topics in the knowledge base. Both can be consulted without an account and provide immediate direction.