The European Union (EU) Medical Device Regulation (MDR) EU 2017/745 replaced the Medical Devices Directive (MDD) on May 25, 2017, with the aim of impr...
New EU MDR Reporting Requirements Coming in 2020
Keeping up with the evolving compliance landscape can be challenging. From a growing list of labeling requirements to additional reporting criteria, c...
Notified Bodies Under the EU Medical Device Regulation: Avoiding Certification Delays
Thousands of medical device companies have until May 2020 to certify their products under the new European Union (EU) Medical Device Regulation (MDR 2...
Ask the Experts: March 29 Edition
Our regulatory subject matter experts are always helping a range of stakeholders solve compelling regulatory challenges associated with supply chain d...
Recertifying a Product Under the European Union Medical Device Regulation
In September 2012, the European Union Medical Device Regulation (EU MDR) 2017/745 was first proposed to address weaknesses in the existing Medical Dev...
The EU Medical Device Regulation: Five Reasons to Stay Compliant
Companies are still figuring out how to manage their requirements under the European Union Medical Device Regulation (EU MDR) 2017/745, and in-scope m...
Ask an Expert: Common Questions About the EU MDR
The European Union (EU) Medical Device Regulation (MDR) EU 2017/745 entered into force on May 25, 2017, with the aim of improving clinical safety and ...