Understanding the New General Product Safety Regulation (GPSR)
The new General Product Safety Regulation (GPSR) is approaching quickly. While the General Product Safety Directive has been in effect for many years, the updated GPSR introduces new challenges. Notably, GPSR also applies to products that do not require CE certification.
Do You Need to Comply with GPSR?
You must comply with GPSR if any of the following apply:
- You sell products directly to consumers and/or businesses within the EU.
- You sell via a marketplace targeting EU consumers or businesses.
- You sell to distributors or resellers who target EU consumers or businesses.
Manufacturer Responsibilities Under GPSR:
Manufacturers are ultimately responsible for the safety and compliance of their products. They must provide all required documentation to supervising authorities upon request.
According to the General Product Safety Regulation (GPSR) 2023/988, manufacturers and importers are required to conduct a risk analysis to ensure that their products do not pose any danger to the health or safety of consumers. This requirement is part of the broader product safety obligations that manufacturers must comply with to meet the safety standards in the European Union (EU).
Smander can conduct this risk analysis for your products or assist in case you want to do it yourself.
We recommend booking a consultation session in both cases.
The Role of an EU Representative (EU-REP, EC-REP, CE-REP)
If your business is located outside the European Union, you are required to appoint an EU representative (EU-REP) for every product sold to end customers within the EU.
This role can be filled by:
- Your own local subsidiary within the EU.
- A specialized compliance company within the EU, often the more practical choice.
Special Considerations for Certain Product Categories
Some product categories, such as medical devices, require specialized compliance services.
Key Duties of the EU Representative:
- Authorized Representation
- The EU-REP must be explicitly authorized by the manufacturer in writing to represent them.
- Documentation and Compliance
- Retain compliance records for at least 10 years after the product is last marketed.
- Provide required information and documents to supervising authorities upon request.
- Risk and Safety Management
- Assess products for risks and compliance.
- Communicate findings to manufacturers and supervising authorities.
- Report risks and product recalls to authorities via the EU Safety Gate platform.
- Labelling Assistance
- Supply the necessary labelling information for EU product sales.
Additional Duties for CE-Certified Products:
If your product requires CE certification, the EU-REP takes on additional responsibilities:
- CE Compliance Representation
- Act as the manufacturer’s representative for all CE compliance matters.
- Assist with affixing the CE mark and issuing declarations of conformity.
- Provide CE documentation to authorities upon request.
- Technical Recordkeeping
- Maintain CE compliance and technical records for at least 10 years after the product is last marketed.
- Risk Reporting and Labelling
- Report risks and recalls to authorities via the EU Safety Gate platform.
- Provide labelling guidance for CE-certified products.
Can Smander.com Serve as Your EU-REP?
We’re working on it!
If you’re a small business looking for an easy and reliable way to authorize an EU Representative (EU-REP), we’d love to hear from you.
Contact us at hello@smander.com to join our interest list.
You’ll be the first to know when we start offering this service!
Stay tuned for updates as we explore ways to simplify product compliance for small businesses.
