EU Product Registration

EU Product Registration

Placing goods on the EU single market.

Manufacturers that wish to place their goods on the EU market must ensure compliance with all the relevant EU requirements. They must demonstrate its compliance within a technical file in accordance with the applicable Directive or Regulation.

Moreover, products must be notified or registered to the EU Competent Authorities subject to the requirements of the respective legislation. For non-EU based manufacturers, this action can be completed by their appointed EU Representative, such as Obelis.

Depending on the product in questions, the procedures may vary:

On the other hand, for some products to be introduced to the EU market, the only requirement is appointment of the EU Representative; Therefore, notification is not necessary. This is applicable for the following groups of products:

  • Radio Equipment
  • Machinery
  • Motor vehicles
  • Pressure Equipment
  • Personal Protective Equipment,
  • GPSD

Do not forget that the UK has officially left the EU and as of January 1, 2021 different legal regime of registration is applicable on the GB market. For all UK-related procedures, we recommend you to appoint Obelis UK as your UK Responsible Person.

National Registration Services

As the EU is not one single country, Member States may choose to impose an additional registration in order to make the product available on their market. In most cases, this is a one-time requirement, unless a significant change has been made to the product.

Once the EUDAMED is fully functional, the registration requirements for medical devices may change.

However, at the moment the below countries are imposing an additional registration for medical devices and some specific requirements for cosmetic products that are to be placed on their market in which Obelis can assist you:

Obelis is highly recommending manufacturers not to allow third party commercial entities, like distributors to perform national registrations of products, but to allow their EU Authorized Representative to take care of any regulatory & CE marking issues, as:

  • By allowing a third party commercial entity to register in your behalf, the manufacturer relinquishes an essential part of his control over his product in Country. Your registrations in Europe are your Property!
  • If decided to end the relationship with a commercial distributor at any point, it might be required to take the device completely off the market until a re- registration is completed for a second (third, fourth, etc.) time;
  • Your third party commercial entity can expect exclusivity, limiting the open distribution of your product.

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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