Regulations of Reusable Medical Devices under EU MDR
The introduction of the EU Medical Device Regulation (MDR) has brought increased emphasis on robust data and comprehensive evaluations for […]
EU MDR Compliance
Understand the EU MDR requirements for medical device manufacturers. Our articles cover conformity assessment, CE marking, safety documentation, and risk management to ensure products meet European standards.
System and Procedure Packs in Accordance with EU MDR
In today’s healthcare system, the role of system and procedure packs is of great importance. Since these packs contain tools
Meeting EU Regulations: Role of the European Authorized Representative (EAR)
When foreign medical device and IVD manufacturers seek to distribute their devices within the European Union (EU) Member States, compliance
EU MDR Labelling Requirements For Medical Devices
The European Union Medical Device Regulation (EU MDR) has ushered in a new era of regulatory compliance for medical device
Understanding the Role of PRRC under EU MDR and IVDR
The advent of the EU Medical Device Regulations (EU MDR) and In-Vitro Diagnostic Regulation (IVDR) signals a new era of
Conformity Assessment of Medical Devices under EU MDR
The world of medical devices is a realm of constant innovation, where the development of new technologies has the power