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

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.