Relevance also for medical devices from 13 December 2024

The EU General Product Safety Regulation 2023/98 – GPSR, published on 23 May 2024, will enter into force on 13 December 2024 and will be directly applicable from that date. The GPSR lays down general rules for the safety of consumer products placed on the market in the European Union or made available for sale online or in shops on the EU-market.
For those products for which safety-relevant legal acts already exist, the GPSR can nevertheless be applied in addition. Foodstuffs and medicinal products for example are expressly excluded from the scope of the GPSR, but not medical devices.

The specific safety requirements for medical devices are primarily regulated by the Medical Device Regulation (Regulation (EU) 2017/745 – MDR). The GPSR imposes additional requirements, if certain safety risks are not fully covered by the MDR. Those areas of the GPSR that are not covered by the MDR, such as responsibilities of providers of online marketplaces, new information obligations in the case of distant sales, reporting obligations or consumer rights, also apply to medical devices that are intended for or used by consumers.

Some of these relevant provisions of the GPSR are, for example, the following:

• Providers of online marketplaces are subject to new information, monitoring and reporting obligations.
• All economic operators selling their products online must provide contact details, product information and product images. Warnings and safety information must be placed on the product or on the packaging or in an accompanying document in a language easily understood by the Member State in which the product is made available on the market.
• In future, all manufacturers will be obliged to report safety-related incidents via the European Safety Gate rapid alert system. This also provides for a web portal to inform the public, including the option of submitting complaints (Safety Gate portal).
• Consumers must be informed immediately of product safety recalls or safety warnings in writing and in an easily understandable manner, this can also be done via the consumer’s contact details stored for this purpose only or via other channels to reach all consumers. In the event of a product safety recall, the responsible economic operator must offer the consumer an effective, cost-free and timely remedy. The remedy shall not cause significant inconvenience or expense to the consumer.

The provisions of the GPSR bring significant changes, particularly in the digital trade in medical devices, which must be complied with from 13 December 2024. To avoid possible sanctions (to be set by the EU Member States) and collective consumer actions, all economic operators must familiarize themselves with the specific obligations that apply to them. It is also important to put in place internal procedures to be prepared for handling product recalls as well as safety complaints from consumers and to ensure that their rights are properly handled.

unyer Working Group Health Care & Life Science

Barbara Kuchar

Petra Artner