IMDRF issues new final guidance documents

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