EU Product Registration
Guiding you through the compliance process and registering products to be made available on the EU Market.
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 completing a Notification via a harmonized database such as EUDAMED (Medical Devices/In-Vitro Diagnostics) or CPNP (Cosmetic Product Notification Portal) only after the products have sufficiently demonstrated compliance with the applicable legislation. For non-EU based manufacturers, this action can only be completed by their appointed EU Representative.
National Registration Services
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 - particularly as it relates to devices for human health.
- Medical Device Registration in Bulgaria
- Medical Device Registration in Croatia
- Medical Device Registration in France
- Medical Device Registration in Greece
- Medical Device Registration in Italy
- Medical Device Registration in Latvia
- Medical Device Registration in Portugal
- Medical Device Registration in Spain
- Medical Device Registration in Slovakia
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.Get in touch