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. 2024
  3. June
  4. 04

June 4, 2024


The EU regulates medical laboratories – Are Laboratory Developed Tests still allowed?

By Ulrich HafenJune 4, 20242 Comments

This article will help you ensure that you will still be able to offer in-house IVD (also called Laboratory Developed Tests, LDTs) under the IVDR and will explain the three options open to you avoiding legal disputes. In-house IVD are a type of in vitro diagnostic test. But do regulatory requirements such as the IVDR also…

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