GPSR Compliance - EU

 

GPSR Compliance – EU Authorised Representative

Business Name: Med-Di-Dia Ltd
Business Address: Platform 94, Mervue Business Park, Galway H91 D932, Ireland
Contact Email: GPSR@mddltd.com
Reference: Craft Consortium

 

In accordance with Regulation (EU) 2023/988 on general product safety and Regulation (EU) 2019/1020 on market surveillance, Med-Di-Dia Ltd acts as the EU Authorised Representative (EUAR) for Craft Consortium. As required by the regulations, a written mandate is in place between the EUAR and the Manufacturer.

 

As the designated representative, Med-Di-Dia Ltd ensures compliance with the following regulatory obligations:

• Regulatory Documentation & Market Surveillance:

  • Provide market surveillance authorities with a copy of the manufacturer’s mandate upon request.

  • Supply relevant authorities with necessary safety documentation in an official language they understand.

  • Notify the Manufacturer and relevant authorities if a product is deemed unsafe.

• Safety & Risk Management:

  • Report any corrective actions or product safety concerns via the Safety Business Gateway (if not already provided by the Manufacturer).

  • Cooperate with national authorities to address and mitigate product risks.

 

As per the Regulations, the EURP is required to check that the Manufacturer (i.e. Craft Consortium) complies with:

1.      Record keeping requirements

2.      Technical documentation requirements

3.      Provision of instructions and safety information (if applicable)

4.      Labelling requirements, including:

·         Product identification

·         Manufacturer’s name

·         Manufacturer’s postal and electronic address

·         EUAR(RP) name, address, and other contact details

 

Additionally, the EUAR conducts regular compliance checks to ensure that the Manufacturer continues to meet regulatory obligations and can provide evidence of these checks upon request from the authorities.

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For further inquiries, please contact GPSR@mddltd.com.