Medical Devices EU Authorised Representative & UK Responsible Person – Q&A: International Associates Limited

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Medical devices

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Medical Devices are one of, if not the most, complicated, and tightly regulated products to place on the market within the European Union and the United Kingdom. This is not helped by the change from the Medical Device Directive to the new Medical Device Regulations which come into force in May 2021. This has been further complicated by Brexit as different regulations apply in different areas.

The first step is to identify if the product is actually a Medical Device and then which of the Regulation actually applies. Keep reading, and learn what you must know in this article written by International Associates Limited in the UK. Continue reading Medical Devices EU Authorised Representative & UK Responsible Person – Q&A: International Associates Limited

European Authorised Representatives: What Amazon Sellers & Exporters Must Know

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Request a free EU Authorised Representative Quotation Here

Until now it’s largely been a free for all when it comes to selling products cross-border to consumers in the European Union. As of July 2021, this changes drastically. Non-EU companies selling B2C to consumers in the European Union will be required to have an EU address on the packaging.

Packages without an EU address may be seized and destroyed – without any form of compensation to either the seller or the buyer. The solution may at first sound as simple as using a virtual address and expect business as usual.

This is not the case, as you can only use the address of a European Authorised Representative – who in turn will only allow you to use their address if you can provide evidence that your product is safe and fully compliant.

In this guide, we explain what Amazon sellers, cross-border e-commerce businesses, export manufacturers, and logistics companies must know about European Authorised Representatives in 2021 and beyond.

What is a European Authorised Representative?

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List of European Authorised Representative Companies 2021

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Request a free EU Authorised Representative Quotation Here

As of July 2021, non-EU companies selling products to consumers in the European Union must have a European Authorised Representative. Products shipped into the EU must also have the address of the authorised representative.

In this article, we list companies offering European Authorised Representative services for electronics, toys, food contact materials, cosmetics, medical devices, and other products.

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