Labelling requirements for medical devices under the new EU Product Safety Regulation

From 13 December 2024 on the General Product Safety Regulation (GPSR) will apply in the European Union. The GSPR serves as a cornerstone within the framework of European safety regulations, aiming to ensure a high level of safety for all consumer products. Although medical devices are primarily regulated by the sector specific Medical Device Regulation (MDR), the GPSR imposes additional requirements for certain aspects not fully covered by the MDR. The following article explores which specific provisions of the GPSR apply to medical devices and how economic operators are implicated by the GSPR.

General application of the GPSR

The GPSR replaces the old General Product Safety Directive but continues with the familiar approach regarding the area of application. The provisions of the GPSR apply to all consumer products that are placed or made available on the market insofar as there are no specific provisions with the same objective under Union law. Medical devices are generally subject to the MDR. Therefore, Art. 2 para. 1 GPSR excludes medical devices from certain sections of the GPSR, including general labelling requirements in Chapter III, Section 1 GSPR, as the MDR contains similar provisions.

Specific application of the GPSR

In other specific areas, however, the provisions of the GPSR apply to medical devices. Art. 19, 22, 35 para. 2 and 37 GPSR contain provisions relevant to medical devices when economic operators make products available on the market online or through other means of distance sales. These articles address specific aspects of product safety and information provision that are not covered by the MDR.

Article 19 GPSR: Obligations of economic operators in the case of distance sales

Art. 19 GPSR requires that online offers of medical devices must include specific information, including from now on the "email address" of the legal manufacturer. This requirement supplements the labelling provisions of the MDR to ensure that consumers are provided with all relevant safety information when purchasing online.

Article 22 GPSR: Obligations of providers of online marketplaces

Art. 22 GPSR regulates the responsibilities of providers of online marketplaces, who must ensure that the medical devices offered include the necessary information according to Art. 19 GPSR and comply with legal requirements.

Articles 35 para. 2 and 37 GPSR: Communication and remedial measures

Art. 35 para. 2 GPSR governs the use of product registration systems to inform consumers about product safety, while Art. 37 GPSR sets out the requirements for remedial measures in the event product recalls. These provisions are particularly important as they directly impact consumer safety and confidence in medical devices.

Remaining challenges and conclusion

The upcoming application of the GPSR to medical devices presents legal uncertainties, especially regarding obligations that are missing a direct counterpart in the MDR, for instance, the requirement to establish publicly accessible communication channels under Art. 9 para. 11 GPSR. Therefore, legal clarification of these and similar issues remains a challenge for economic operators. The partial application of the GPSR to medical devices, alongside the MDR, necessitates careful attention and implementation of both regulatory frameworks. This includes, in particular, the additional information and safety requirements provided by the GPSR for online trade and other specific situations. Continuous monitoring of legal developments and a proactive compliance strategy are essential to ensure regulatory compliance and to strengthen consumer confidence in the safety and reliability of medical devices. Economic operators should therefore be prepared to adapt their processes and systems to meet both current and future requirements.