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.
The Representative of choice for
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.
Compliance Success Stories
“We can always count on the quick response of the Obelis team. Managing the huge amount of data necessary for a EU Notification is very complex yet they make is seem so easy.”
“We were under huge time and cost pressure for a new product line launch and we relied on Obelis. It was the right decision. Their expert team helped us to avoid possible regulatory complications.”
“I encourage companies to seek compliance before putting their devices on the market. Working with Obelis to gain swift regulatory approval across several markets has had a profound impact on our company.”
