The Medical Device Regulation (MDR) changes the legal framework for medical devices in Europe. The MDR became fully applicable beginning in May 2021. The transition period from the former regulation framework Medical Devices Directive, during which manufacturers must recertify medical devices in accordance with the new regulation, was originally scheduled to last until May 2024.

The EU recently published new legislation that extends the transition period (upon meeting certain criteria) to December 2027 or December 2028, depending on the class of the device. This extension, however, does not mean anyone can relax, but it does open a window of opportunity for successful implementation. 

As a manufacturer, you are no doubt under pressure as you try to navigate the complex details of MDR and work towards compliance with the new requirements.  

How prepared are you and your team for the transition to new Medical Device Regulation?