In 2023, the EU adopted a new regulation that defines general safety and quality standards for products marketed in the EU. This regulation comes into force on 13 December 2024.
Who is the Regulation Relevant for?
From 13 December 2024, the following will also apply to economic operators in the medical devices sector: GPSR – these are not excluded from the scope of application.
The requirements of the GPSR apply whenever no more specific requirements have been defined in the European Medical Device Regulation (MDR). Furthermore, a draft amendment to our national Product Safety Act (ProdSG) is still being prepared in order to transpose this EU regulation into national law.
What Aspects Should Economic Operators or Manufacturers Consider?
For you as an economic operator or, if applicable, a manufacturer of medical devices, requirements in the following areas, in particular, must be taken into account and implemented in addition to the MDR:
- Specific obligations of economic operators with regard to distance selling
- Where medical devices are made available on the market online or via any other form of distance selling, the offer must include the information specified in Article 19 of the ‘GPSR’
- Special obligations of online marketplace providers in connection with product safety
- Online marketplace providers must register with the Safety-Gate portal and submit their details there
- A central point of contact for consumers regarding product safety issues is to be set up.
- Reported information about dangerous products that you receive via the Safety Gate portal must be taken into account and action taken if necessary.
- Reports must be processed immediately, and in any case within three working days.
- Online marketplaces must be designed in such a way that consumers can be provided with the information required under Article 22(9) of the ‘GPSR’ for each product on offer
- Information on dangerous products must be reported to the market surveillance authorities via the Safety Business Gateway (Article 26, ‘GPSR’)
- Provision of information to consumers on product safety by economic operators and online marketplace providers (Article 35 of the ‘GPSR’)
- Economic operators and providers of online marketplaces with product registration systems or customer loyalty programmes that enable the identification of products purchased by customers for purposes other than providing safety information to their customers shall provide their customers with the option of registering separate contact details for safety purposes only.
- Abhilfemaßnahmen im Falle eines Produktsicherheitsrückruf (Artikel 37 „GPSR“)
- In the event of a recall, the responsible economic operator shall offer the consumer a choice between at least two of the following remedies:
- Repair of the recalled product,
- Replacement of the recalled product with a safe product of the same type, of at least the same value and quality, or
- Reimbursement of the value of the recalled product, provided that the reimbursement amount is at least equal to the price paid by the consumer.
- In the event of a recall, the responsible economic operator shall offer the consumer a choice between at least two of the following remedies:
We’d be happy to assist you with any questions you may have regarding the GPSR – contact us!
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