Under the Regulation (EU) 2023/988 General Product Safety Regulation (GPSR), an EU Responsible Person is an entity within the European Union designated to ensure that non-EU manufacturers' products comply with EU safety requirements. This role can be fulfilled by an authorised representative, importer, manufacturer, or fulfilment service provider based in the EU.
The EU Responsible Person acts as the primary contact for regulatory authorities, handles compliance documentation, and oversees post-market surveillance activities such as incident reporting and recalls. Appointing an EU Responsible Person is mandatory for non-EU manufacturers to legally sell their products in the EU.
Under the Regulation (EU) 2023/988 General Product Safety Regulation (GPSR), an EU Responsible Person will include the following responsibilities:
Ensure compliance: Verify that products meet all GPSR and EU safety requirements.
Maintain documentation: Hold and update the technical file for regulatory inspections.
Check labelling: Confirm proper product labelling and traceability information.
Act as liaison: Serve as the contact point for EU market surveillance authorities.
Report incidents: Notify authorities of any safety issues or non-compliance.
Support recalls: Assist in product recalls or corrective actions when needed.
Respond to inquiries: Provide regulators with necessary documentation and information.
Monitor the market: Conduct post-market surveillance and handle safety complaints.
Cooperate with authorities: Facilitate investigations and support regulatory actions.
Terminate their mandate as EU Responsible Person if the manufacturer acts contrary to the GPSR.
Is appointing an EU Responsible Person mandatory for all non-EU manufacturers under the GPSR?
Yes, under the General Product Safety Regulation (GPSR), which takes effect on 13 December 2024, non-EU manufacturers are required to appoint an EU-based 'responsible person' to ensure their products comply with EU safety standards.
This responsible person can be an authorised representative, importer, manufacturer, or fulfilment service provider established within the EU. The responsible person acts as the primary contact for regulatory authorities, maintains technical documentation, and oversees post-market surveillance activities. Non-EU manufacturers must appoint this responsible person by the 13 December 2024 deadline to legally place their products on the EU market.
Since Med-Di-Dia is already a trusted EU Authorised Representative (EU AR) for the medical industry, we are proud to extend our expertise to all companies affected by the General Product Safety Regulation (GPSR). With the 13 December 2024 deadline approaching, we offer comprehensive EU AR services tailored to ensure compliance with GPSR requirements, including technical documentation maintenance, regulatory liaison, and post-market surveillance. Let us help you navigate these new regulations and secure your market access seamlessly.
Benefits of using Med-Di-Dia as your EU Responsible Person?
Proven Expertise in EU Authorised Representation
Med-Di-Dia has extensive experience as an EU Authorised Representative (EU AR) for the medical industry, ensuring seamless regulatory compliance for manufacturers under stringent EU regulations like MDR and IVDR.
Comprehensive GPSR Knowledge
Our team is fully equipped with in-depth knowledge of the General Product Safety Regulation (GPSR), ensuring your products meet all compliance requirements ahead of the 13 December 2024 deadline.
Central Point of Contact
We act as a reliable liaison between non-EU manufacturers and EU regulatory authorities, facilitating clear and efficient communication for audits, inquiries, or investigations.
Streamlined Compliance Processes
Med-Di-Dia simplifies compliance by maintaining technical documentation, ensuring proper labelling, and overseeing post-market surveillance activities, saving your business time and resources.
Tailored Support for a Wide Range of Products
With expertise across diverse product categories, we offer services that align with your specific industry needs, including non-medical products affected by the GPSR.
Proactive Incident Management
Our team ensures timely reporting of any product safety concerns to EU authorities, helping to minimise risks and protect your market position.
Regulatory Resilience and Future-Proofing
As industry regulations evolve, we stay ahead of changes, ensuring your business remains compliant and competitive in the EU market.
Dedicated Client Support
At Med-Di-Dia, we prioritise personalised service, working closely with your team to address compliance challenges and navigate regulatory complexities with confidence.
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