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 Success Stories
“We can always count on the quick response of the Obelis team. Even with the six-hour time difference, they are always available for consultation. Managing the huge amount of data necessary for a EU Notification is very complex yet they make is seem so easy.”
“I would encourage companies to seek compliance before putting their devices on the market, preferably with a reliable partner. Working with Obelis to gain swift regulatory approval across several markets has had a profound impact on our company.”
“We have been under huge time and cost pressure for a new OEM product line launch and we relied on Obelis for the first time. Afterwards, I can say that it was the right decision.Their expert team helped us to avoid possible regulatory complications.”
