EVERBIZ News Center: company news, global medical device regulatory updates, and registration and compliance insights.
Exporting IVD Instruments to the US: How FDA and FCC Requirements Relate
For IVD instruments with wireless functions, FDA clearance and NRTL certification must be complemented by FCC equipment authorisation and FDA cybersecurity requirements.
Medical Device Cybersecurity in Focus: Lessons from the CMS8000 Patient Monitor Vulnerabilities
What the FDA’s January 2025 safety communication on the CMS8000 patient monitor revealed, and how FDA, EU and NMPA cybersecurity requirements have tightened.
IVDR Performance Evaluation Report at a Glance: A 12-Section Framework
A practical structure for the performance evaluation report of an IVD under the IVDR – from product description and risk analysis to scientific validity, analytical and clinical performance.
IVDR Registration (Part 2): The Performance Evaluation Plan
What an IVDR performance evaluation plan must contain under Annex XIII, how to demonstrate scientific validity, analytical and clinical performance, and how to tackle common challenges.
IVDR Registration (Part 1): Key Points of the IVDR Transition Extension
Extended IVDR transition deadlines for legacy devices under Regulation (EU) 2024/1860, the conditions that apply and the actions manufacturers must take.
IVDR Performance Studies at a Glance (Part 3): The Clinical Performance Study Plan
Purpose, ethics and design of IVDR clinical performance studies, the content of the clinical performance study plan (CPSP) under Annex XIII and the study report.
IVDR Registration (Part 4): ISO/IEC 27001 Explained – and How It Relates to the IVDR
What ISO/IEC 27001 is, where the IVDR sets information security requirements, and how ISMS clauses map to key documents.
NMPA Registration in China: AI Medical Devices (Part 1)
Key concepts of China’s NMPA guideline for the registration review of AI medical devices: definitions, device types, review principles and the algorithm research report.
NMPA Registration in China: Medical Device Cybersecurity (Part 3)
Scope, protection levels and capabilities required by the NMPA cybersecurity guideline, plus the cybersecurity information needed in technical requirements and instructions for use.
NMPA Registration in China: The Cybersecurity Research Report (Part 4)
The structure of the cybersecurity research report required for NMPA registration: basic information, implementation process, vulnerability assessment and conclusion.
NMPA Registration in China: Medical Device Cybersecurity (Part 1)
Applicable Chinese regulations and standards, scope, and the content required in the cybersecurity part of an NMPA registration dossier.
EN 17161 vs EN 301 549: Key Differences and Relevance for Medical Devices
How the Design-for-All standard EN 17161 and the ICT accessibility standard EN 301 549 differ, and which one is relevant for which kind of medical device.