+39 06 5782665
Italy - UK - USA

IMDRF issues new final guidance documents

  • Posted by: inetika
  • Category: GLOBAL NEWS

The International Medical Device Regulators’ Forum (IMDRF) issued four new or revised final guidance documents on 20 April 2020, these being:

  • Principles and Practices for Medical Device Cybersecurity
  • Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews
  • Personalized Medical Devices – Regulatory Pathways
  • IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes
Copies can be downloaded from the IMDRF website ‘Documents’ page.