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, non-compliant batches, etc. They along with the Responsible Person must take action immediately to resolve the situation.

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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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