EU Product Registration for medical devices

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.

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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

Why Obelis?

Our deep and long-standing experience with Swiss, EU and UK compliance frameworks makes us the best choice to support your products’ path towards compliance in these territories.

Our team regulatory experts will guide you through medical devices’ technical documentation, notification, labelling, among others.

About us
Founded in 1988, we are among Europe’s largest centres for advisory and representative services.
We are certified by ISO 9001:2015 and ISO 13485:2016.
We have helped over 3,000 manufacturers from over 60 countries address their regulatory challenges.
We are members of professional associations and more than 10 European Commission working groups.
Obelis International Offices (OIO) comprise independent partners providing solutions in other global markets.
Our team consists of lawyers, chemists, pharmacists, and other experts. Our close-knit culture has been certified by the Great Place to Work Survey 2022-23.