EU Product Registration

Guiding you through the compliance process and registering products to be made available on the EU Market.

EU & non-EU based manufacturers that wish to make their goods available on the EU market may only Register (Notify) their products once they have demonstrated their compliance within a technical file per the applicable legislation(s).

Depending on the legislation, this may mean a registration via a harmonized database such as Eudamed (Medical Devices/In-Vitro Diagnostics) or CPNP (Cosmetic Product Notification Portal).

As the EU is not one single country, some countries may choose to impose an additional Registration in order to make the product available in that country.

The EU does not approve products before they may be made available for sale. Instead, manufacturers are expected to follow the requirements laid out in the legislation and to "let them know" before placing them within the EU by means of Notification.

For non-EU based manufacturers, this product registration (notification) must be completed on their behalf by their EU Representative.

The EU Authorities then focus on in-market controls:

  • Stopping products at customs
  • Periodically auditing manufacturers and/or their EU Representative
  • Unannounced audits of importers/distributor warehouses
  • Systematically checking products on shelves
  • Using bots to comb the internet for websites that offer shipping to the EU
  • Looking into reports of adverse effects - either to government entities or online sources (i.e. social media, reviews, etc.)

In most cases, product registration is a one-time requirement unless a significant change has been made to the product; however, it is important that you remain up-to-date as the laws evolve. The EU does not "grandfather" products which have already been selling.

Allow Obelis to assist in navigating the complexities of the EU Product Registration, allowing you to focus your efforts on sales.

Interested in how your EU Compliance can serve you in other global markets? Learn about Obelis Free Sales Certificate services.

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