Summary
- Profile Type
- Business Offer
- POD Reference
- BOIE20241031022
- Term of Validity
- 31 October 2024 - 31 October 2025
- Company's Country
- Ireland
- Type of partnership
- Commercial agreement
- Targeted Countries
- All countries
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General information
- Short Summary
- The Irish service provider offers regulatory compliance support for manufacturers, e-commerce sellers who are not located in EU. EU regulatory framework such as General Product Safety Regulation (GPSR), Medical Device Regulation (MDR), Cosmetic Products Regulation (CPR) requires an appointed entity located in EU before products can be placed on the EU market. Commercial agreements are sought.
- Full Description
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The Irish company provides regulatory compliance support in the field of consumer products, medical devices, cosmetic products, which are regulated by (EU) 2019/1020, (EU) 2017/745, (EC) No. 1223/2009 and other Union regulations. The company supports the non-EU manufacturers or online sellers to draft and maintain the technical documentation for their products.
The following service can be provided:
Consumer products: GPSR will be fully enacted on 13 December 2024. Consumer products without authorised representative information on their package will not be able to enter the EU market. The Irish company can support clients to conduct product safety assessments, manage technical documentation, and offer authorised representative service.
Medical devices: MDR/IVDR are under transition. Devices without MDD/IVDD CE certification are required to apply to new regulations. The Irish company offers authorised representative and legal importer services to support clients expedite their process in new regulation compliance.
Cosmetic products: Under EU CPR, product information files shall be built, and products shall be registered via CPNP system by a responsible person. The Irish company offers a full service from safety assessment, completion of product information files, and product registration services. Product registration to the UK system is also possible.
The company is looking for commercial agreements with non-EU manufacturers/online sellers. The company will take the role of authorized representative/responsible person within the EU regulatory framework to support their partner placing their products to the EU market legally. - Advantages and Innovations
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The company has supported their clients to place their consumer products, medical devices, and cosmetic products to the EU market legally. The company has registered their authorized representative and importer roles to the competent authority and helped manufacturers sort out compliance issues. Their professional network enables them to provide additional services other than regulatory compliance such as 3rd party logistics and warehouse service within the EU.
Client in need of EU regulatory compliance support or authorised representative/responsible person service in the field of consumer products, medical devices, and cosmetic products. - Stage of Development
- Already on the market
- Sustainable Development Goals
- Goal 8: Decent Work and Economic Growth
Partner Sought
- Expected Role of a Partner
- From 13 December 2024, non-EU manufacturers/online sellers will need an EU authorised representative per GPSR Regulation. The company provides authorized representative/responsible person service under commercial agreements for those who need an entity within the EU territory to comply with the new regulation.
- Type and Size of Partner
- Big company
- SME 50 - 249
- SME 11-49
- SME <=10
- Type of partnership
- Commercial agreement
Dissemination
- Market keywords
- 08006001 - Process control and logistics
- 09003004 - Distributors, imports and wholesalers
- 09003005 - Consulting services
- Targeted countries
- All countries