All medical devices in the EU are subject to the Medical Device Regulation. Accordingly, many have argued that other European regulations do not apply to medical devices and to economic operators in the health care sector. That is false. In addition to the MDR, which contains rules for this sector specifically, a number of inter-sector “horizontal” regulations must also be heeded (e.g. the future AI Act, the future Corporate Sustainability Reporting Directive and the NIS‑2 Directive).
This is also the case for the new EU General Product Safety Regulation (GPSR) which replaces Directive 2001/95/EC on general product safety and which is applicable to all consumer products, including medical devices. The provisions of the GPSR apply unless a more specific provision can be found in the MDR.
“Fulfilment service providers”
This is the case e.g. with regard to “fulfilment service providers,” which are not mentioned in the MDR and which are defined in the GPSR as someone “offering, in the course of commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching, without having ownership of the products involved, excluding postal services … , parcel delivery services … , and any other postal services or freight transport services.” Fulfilment service providers qualify as economic operators in terms of the Product Safety Regulation, alongside manufacturers, authorised representatives, importers and distributors. Fulfilment services which involve medical devices will therefore be subject to both the MDR and the General Product Safety Regulation in the future.
Online sales of consumer products will also be subject to a single set of European regulations with the adoption of the General Product Safety Regulation. The MDR already contains legal obligations for distributors of medical devices, as well as requirements for distance selling. The General Product Safety Regulation also defines the terms “online marketplace” and “online interface,” creating legal certainty in this regard. In addition, Chapter IV of the General Product Safety Regulation deals explicitly with sales through online marketplaces and Article 20 of the Regulation establishes specific obligations for online marketplaces with regard to product safety, which are formulated in a depth which cannot be found in the MDR.
Economic operators which place medical devices on the market as consumer products will be subject not only to the Medical Device Regulation but to the EU General Product Safety Regulation as well. Particularly fulfilment service providers, operators of online marketplaces and those engaged in online selling need to familiarize themselves with the content of the General Product Safety Regulation and implement its provisions so as to ensure that their distribution activities conform to regulations. We can provide assistance when it comes to identifying the requirements which apply in each case and implementing those requirements in a legally certain manner. Please let us know if we can help you in this regard.back