Skip to content
Regulatory knowledge for medical devices
Articles on the development and approval of medical devices and other regulatory topics
Regulatory knowledge for medical devices
CONTACT USLogin
Search:
  • Consulting
    • Market Access
      • Market Access US & International
      • Market Access Europe
      • MDR / IVDR Consulting
      • IVD Admission Strategy
      • AI Medical Devices
      • And more…
    • Quality System
      • Quality management systems (ISO 13485)
      • ISO 13485 audits
      • Quality management representative
      • Quality management system as a service
    • Technical Documentation
      • Software (IEC 62304, FDA)
      • Risk Management (ISO 14971)
      • Clinical Evaluation
      • Performance evaluation of IVDs
      • Electrical Safety & IEC 60601
      • Human Factors / Usability (IEC 62366 and FDA)
      • FDA relevant documents
    • Product test
      • Human Factors Research
      • Safety and EMC test laboratory
      • Biological safety
      • Computer System Validation
    • Seminars
      • Seminar Overview
  • Digital Transformation
  • Medical Device University
  • Regulatory Intelligence
    • Post-Market Radar
    • Regulatory Radar
  • About us
    • The Company
      • Our Mission
      • Our Values
      • Certificates
    • People
      • The Team
      • Our Customers
    • Locations
    • Jobs at Johner Institute
      • Current Vacancies
      • Why the Johner Institute?
  • Consulting
    • Market Access
      • Market Access US & International
      • Market Access Europe
      • MDR / IVDR Consulting
      • IVD Admission Strategy
      • AI Medical Devices
      • And more…
    • Quality System
      • Quality management systems (ISO 13485)
      • ISO 13485 audits
      • Quality management representative
      • Quality management system as a service
    • Technical Documentation
      • Software (IEC 62304, FDA)
      • Risk Management (ISO 14971)
      • Clinical Evaluation
      • Performance evaluation of IVDs
      • Electrical Safety & IEC 60601
      • Human Factors / Usability (IEC 62366 and FDA)
      • FDA relevant documents
    • Product test
      • Human Factors Research
      • Safety and EMC test laboratory
      • Biological safety
      • Computer System Validation
    • Seminars
      • Seminar Overview
  • Digital Transformation
  • Medical Device University
  • Regulatory Intelligence
    • Post-Market Radar
    • Regulatory Radar
  • About us
    • The Company
      • Our Mission
      • Our Values
      • Certificates
    • People
      • The Team
      • Our Customers
    • Locations
    • Jobs at Johner Institute
      • Current Vacancies
      • Why the Johner Institute?
You are here:
  1. Home
  2. 2025
  3. October
  4. 06

October 6, 2025


Classification of in-vitro diagnostic medical devices: how to avoid a too-high classification

By Dr. Juliane HavlicekOctober 6, 2025Leave a comment

The classification of in-vitro diagnostics (IVD) can have far-reaching consequences, as it has an impact on the conformity assessment procedure, certification audits, and, thus, on market launch. To help you prevent the unnecessary allocation of your IVD product to a high-risk class, this article provides an overview of

Details

Intended purpose and intended use: More consequences than you think!

By Dr. Juliane HavlicekOctober 6, 20252 Comments

The correct and precise formulation of the intended purpose of medical devices and in vitro diagnostic medical devices (IVD) is crucial for their successful development and approval. However, even the definitions of terms and the connection between intended purpose and intended use make it difficult to achieve clarity and precision. This article reveals how to…

Details

Stay informed with our newsletter!

Medical Device Briefings

Your trustworthy source to safely navigate the medical device regulations.

SIGN UP
  • LinkedIn
  • Locations
  • GTC
  • Login
  • LinkedIn
JI Bottom Bar
Go to Top