Post-Market Surveillance

It is the responsibility of each brand owner to continue to collect information related to the use of their products after they have been made available to consumers as well as to ensure that they continue to comply with the applicable legislation considering the ongoing regulatory updates.

Ensuring Compliance

Manufacturers must keep their EU Responsible Person informed of any changes in formulation, claims, product names or any other matters that could potentially impact the compliance of their product.

As consumers use the products, any undesirable or Serious Undesirable Effects (SUE) reported by end users should also be recorded within the respective Product Information File (PIF), revised within the Safety Assessment report if needed and, depending on the circumstances, reported to the competent authorities.

When a manufacturer becomes aware of a non-compliant product entering the market, they along with the Responsible Person must take action immediately to resolve the situation.

Compliance stands for safety, so should your products!

We register your product in the EU in 3 working days! Get your free consultation today!

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.