IVDR Transition Timeline

IVDR Transition Timeline

It was adopted on April 5, 2017, and replaced the previous In Vitro Diagnostic Directive (IVDD). The IVDR transition timeline is as follows:

 

The new EU 2017/746, IVDR Transition Timeline is as follows

  • December 31, 2027, for higher risk class devices
  • December 31, 2028, for medium and low-risk class devices

Important Changes in the EU IVD Regulation

The In Vitro Diagnostic Regulation (IVDR) showcases a few major changes in the regulatory pathway for invitro devices in Europe, a few are outlined below.

  1. Increased Notified Body Involvement: Under the IVDR, a substantial 80-90% of IVDs sold in Europe will require Notified Body intervention
  2. No Grandfathering Provisions: Unlike the IVDD, the IVDR does not provide grandfathering provisions.
  3. Risk-Based Classification: The IVDR follows a risk-based classification scheme (Classes A, B, C, and D)
  4. Expanded Scope: The IVDR  includes SaMD, apps, single-use IVDs, companion diagnostics (CDx), and genetic tests.
  5. Stringent Requirements for Clinical Evidence: There are heightened requirements for clinical evidence and performance studies, a
  6. Vigilance and Post-market Surveillance: More stringent requirements for vigilance and post-market surveillance
  7. Focus on Labeling and UDI Product Traceability: Major focus is placed on labelling identification and Unique Device Identification (UDI)
  8. Mandatory Appointments: EU Representative a Person Responsible for Regulatory Compliance (PRRC) are made mandatory
  9. Quality Management System (QMS) Requirements: Manufacturers of Class B, C, and D devices are obligated to have a QMS and unannounced Notified Body inspections

 

The IVDR introduces a comprehensive framework structured to enhance the safety and performance of IVDs in the European market, emphasizing increased scrutiny, expanded scope, and more rigorous post-market obligations for manufacturers.

Need Help with IVDR Technical Documentation?
We have the resources and knowhow!
More details
Need Help with IVDR Performance Evaluation?
We have the resources and knowhow!
More details
Are you looking for IVDR pricing?
Check out the most economic pricing
More details
Quick Contact