From 13 December 2024, general products falling within the scope of the General Product Safety Regulation (GPSR) must comply with the new Regulation when placed on the EU market. Products compliant with the Directive (the current GPSD) can be placed on the market until 12 December 2024 and can stay on the market.
The new GPSR brings additional requirements compared to the Directive, such as the introduction of the Responsible Person.
Responsible Person for GPSR
The Responsible Person is an economic operator, which can be the manufacturer (the brand owner) if based in the EU, the importer, the authorised representative (EAR), or the fulfilment service provider. Manufacturers have the option to designate an EAR to serve as the Responsible Person within the EU market. If a manufacturer lacks both an importer and an EAR, the fulfilment service provider assumes by default the role of the Responsible Person.
Authorised Representative acts as Responsible Person
The Authorised Representative can act as Responsible Person (RP) when agreed in the written mandate. In this case, the Authorised Representative (EAR) will undertake several key responsibilities designated to both the EAR and RP, including verifying:
- Technical documentation
- Labels and Instruction for Use (IFUs)
- Type, batch or serial number which enable product identification
- Manufacturer’s details, such as name, their registered trade name or registered trademark, their postal and electronic address
In addition, the EAR has the following obligations:
Cooperate with authorities upon request to mitigate product risks.
Provide market surveillance authorities with necessary documentation to demonstrate product safety upon request.
Notify the manufacturer if they suspect a product is dangerous.
Inform national authorities about actions taken to address product risks.
Obelis can act as your Responsible Person and Authorised Representative for GPSR products.
References:
EUR.Lex (2023). Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety. Retrieved on 25/11/2024.
Regulatory Intelligence & Innovation Department
25.11. 2024
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