EU Product Registration

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.

Placing goods on the EU single market

Manufacturers who 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:

Note 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.

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Our team of lawyers, chemists, pharmacists, and other experts represents the largest centre in Europe for CE Marking and EC REP services.
Founded in 1988, Obelis is certified by ISO 9001:2015 and ISO 13485:2016, and partakes in various EU associations and EU commission working groups.
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