Irish HPRA information pack on MDR and IVDR

Posted on 03.07.2018

The Irish Competent Authority HPRA (Health Products Regulatory Authority) published an information pack on MDR and IVDR.

The HPRA New EU Medical Device Legislation Information Pack covers the following topics:

  • Changes to Scope
  • Certificate Validity during Transition
  • Incoming Process Changes (Notified Body Designation, Scrutiny, IVD Classification, Vigilance Reporting, Clinical Investigation Process)
  • Stakeholder Communication and Engagement
  • Economic Operators Obligations under the new EU Medical Device Regulations
  • Classification under the Medical Devices Regulation (MDR, IVDR)
  • Innovation in the MedTech sector

In order to download this documents, please click here.