Règlement européen relatif aux dispositifs médicaux (MDR)

The EU MDR is set to replace the MDD in May 2021. The newer regulation is intended to increase the safety, transparency and usage of medical devices sold in the EU.

While the EU MDR doesn't specify the conformity assessment route a manufacturer must use, most device makers will use ISO 13485:2016. However, compliance with ISO 13485 doesn't guarantee that a medical device will be fully compliant with the EU MDR.

The EU MDR replaces the Medical Device Directive (MDD) on May 2021 for all medical devices sold in the EU. The new regulation is meant to increase transparency and the stringency of the approval and usage of devices while also improving patient safety and outcomes.

The EU's new MDR increases premarket conformity requirements for all medical devices sold in the EU. The regulation also has more stringent risk assessment requirements, allows for greater tracking of device performance and safety, reclassifies a device based on its purpose.