What is new
The General Product Safety Regulation applies from 13 December 2024. It replaces the 2001 Product Safety Directive and explicitly covers connected products and digital elements. Wi-Fi toys. App-controlled appliances. Wearables. All are now unambiguously inside GPSR.
Online marketplaces are in scope. Safety Gate is wired into the big platforms. A Safety Gate entry leads to delisting demands on Amazon, Zalando and equivalents. The visibility of safety problems has structurally increased.
Manufacturers must document an internal risk analysis covering all foreseeable use scenarios, including foreseeable misuse. For manufacturers without an EU establishment, naming a responsible person in the EU is an explicit duty. Failure to nominate is an offence in itself.
Practical consequences
The internal risk analysis is now an explicit, documented duty — not an implicit expectation. No documented analysis means an explicit GPSR breach.
For connected products, the explicit capture of digital elements is added. Software updates that change safety properties can affect conformity. A documented update management process is required.
Incident reporting under GPSR is sharper and stricter. The deadline is short. Hesitation adds liability exposure.
For Swiss manufacturers
The Swiss Product Safety Act PrSG has adopted the essential GPSR requirements. GPSR conformity yields de facto PrSG conformity on the essentials. The Swiss-specific details — language obligations, market-surveillance practice — still need attention.
Excerpt from: Dr. Raphael Nagel — "Marktzulassung. How to bring your product to market in Switzerland and the EU — without recall, without liability, without detours." Tactical Management Press, 2026.