The 9 most important questions about product monitoring

Dr. Carsten Schucht: In the legal profession, a distinction has long been made between the pre-market on the one hand and the post-market on the other with regard to the obligations of economic operators: The dividing line is drawn by the placing on the market (by the manufacturer and importer) or the making available on the market (by the distributor). Obligations that have to be fulfilled beforehand belong to the pre-market.

Dr. Carsten Schucht: Yes, this requirement is set out there. These specific after-market obligations are regulated in Art. 10 para.4 subpara.2 of Regulation (EU) 2023/1230 for completed machinery. However, it should be noted that these obligations under public law only round off what the legal system has long required of manufacturers of goods in particular in other areas of product law.

Dr. Carsten Schucht: In this respect, civil law is of central importance: according to this law, there are product monitoring obligations, particularly for manufacturers of goods, which are sometimes spelled out in detail. In Germany, these product monitoring obligations are anchored in Art. 823 para. 1 of the German Civil Code (BGB), the so-called producer liability, which expressly stands alongside the product liability determined at European level in the German Product Liability Act (ProdHaftfG).

Dr. Carsten Schucht: First of all, every manufacturer should be aware that a stricter standard applies in civil law than in public law. Put simply, civil law is concerned with the particularly dynamic state of the art in science and technology, whereas public law is only concerned with the state of the art.

In concrete terms, this means that a manufacturer should, on the one hand, take a close look at the case law of the highest courts. This is because the scope of the product monitoring obligations is unfortunately not set out in the law. On the other hand, they must anticipate what the supreme court rulings will look like in areas where there are no rulings yet. Such gaps still exist in the area of “product monitoring in digitalization”, for example. It is therefore anything but clear what case law expects from a machine manufacturer, for example in the area of social media screening or in relation to data generated by so-called smart products.

Dr. Carsten Schucht: Yes, but more in the area of risk prevention and less in the area of product monitoring. This is because if legally relevant hazards are identified in the course of product monitoring, then the product monitoring obligation is transformed into a so-called obligation to avert danger. The aim must then be to effectively eliminate the existing product hazards in the field, and to do so immediately! If a necessary recall is then nevertheless omitted, a sufficient safety warning is not issued or the field action in question is simply inadequate, then criminal law can come threateningly close for the persons responsible!

Dr. Carsten Schucht: This distinction is indeed important: while the actual manufacturer must actively and passively monitor its products after they have been placed on the market, the quasi-manufacturer, importer and (distributor) retailer focus on the passive product monitoring obligation.

Active means - unsurprisingly - taking care of relevant information relating to the product themselves. For example, the manufacturer sends the responsible persons to specialist congresses or instructs them to familiarize themselves with the current technical literature. Active product monitoring also includes looking at competitor products: Are there any safety-relevant aspects that the competition manages differently or even better?

In contrast, passive product monitoring only involves receiving incoming complaints. For retailers in particular, it is sufficient to simply forward these to the responsible body, which is usually the manufacturer or importer, and ask for appropriate “instructions” from there. It is then up to the manufacturer to keep the retailer up to date on how to proceed once the complaint has been investigated. A possible announcement would then be an immediate sales stop. The retailer should of course comply with this.

Dr. Carsten Schucht: This is now often a combination of traditional methods of active and passive product monitoring and engagement with social media. Smart products can also generate a large amount of relevant data that can also be used for the purposes of product monitoring.

Dr. Carsten Schucht: Absolutely! Such information is an elementary component of the passive product monitoring obligation! Moreover, every economic operator can be expected to receive such information. Depending on their specific role, they can leave it at simply forwarding the information to the responsible body (retailer) or must analyze it in detail themselves (manufacturer).

Dr. Carsten Schucht: This question is one of the most difficult in current product law. And it is therefore often the starting point for mandating law firms specializing in product law. Roughly speaking, the facts of the case must be properly clarified from a technical perspective. This includes, in particular, a proper risk assessment. This is followed by a legal assessment. Serious defects will typically result in a field action, i.e. usually either a recall or a safety warning.
There is a clear trend across the EU towards safety warnings in the B2B sector, while a recall may also be necessary for consumer products.