Are you overwhelmed by the changes the new MDR brought for your medical devices?
We make sure that you implement them as required.
As of May 26, 2021, the new EU Medical Devices Regulation (EU-MDR 2017/745), which is intended to ensure greater safety and transparency for medical devices within the European Union, is ultimately considered mandatory.
This new framework changes the requirements that manufacturers of medical devices have to meet: In order to sell their products on the EU market, important changes in the classification system must be adhered to and a more comprehensive conformity assessment must be carried out.
Even formerly approved medical devices must explicitly be classified according to the new regulations within the transition period.
So anyone who wants to continue to sell their medical devices in the EU or who wants to launch a new medical device on the market must now comply with the MDR. If you as a manufacturer are facing this challenge, THE FORCE will support you in
- ...analyzing where your products need to be adapted from former to new legal requirements.
- ...adapting the technical documentation for your medical devices accordingly or to create new documentation.
- ...adapting your quality management system sustainably to the new standards.
- ...training your employees for the new processes and requirements.
- ...preparing optimally for the certification audit by a Notified Body.