To sell in the European Union, manufacturers must have and keep up to date the technical documentation for their medical devices. This applies to all manufacturers of medical devices and IVD medical devices, whether based in the EU or not.
The technical documentation has to include all elements relevant for the device set out in the Medical Devices and IVD Medical Devices Regulations (MDR and IVDR) to demonstrate conformity with the applicable Regulations.
A compliant technical file is a key aspect when aiming to obtain the CE marking for the European markets.
Our
Compliance Success Stories
“We can always count on the quick response of the Obelis team. Managing the huge amount of data necessary for a EU Notification is very complex yet they make is seem so easy.”
“We were under huge time and cost pressure for a new product line launch and we relied on Obelis. It was the right decision. Their expert team helped us to avoid possible regulatory complications.”
“I encourage companies to seek compliance before putting their devices on the market. Working with Obelis to gain swift regulatory approval across several markets has had a profound impact on our company.”
