With the inception of the European Medical Device Regulation, the medical sphere received something unique. However, the deadline for ensuring EU MDR’s compliance is imminent. As a matter of fact, these regulations require healthcare equipment manufacturers to embrace technological revolutions.
By this move, the manufacturers can enable and improve traceability, besides devices’ safety management within the EU. Furthermore, the regulations bring an EU identification system for healthcare devices on the basis of UDI or Unique Device Identifier. So, before understanding the MDR checklist, here are the scopes and duties.
What Are the Duties And Scopes Of MDR Compliance?
EU regulators may have quality management and risk management systems. Besides, these regulators can conduct the clinical evaluation, compile all technical documentation, and apply conformity assessment techniques.
What to Know About MRD Checklist?
Now that you’ve understood its scopes and duties, here’s presenting everything about the EU MDR checklist. These are the tasks that you require including in the action plan. They are: