In Vitro Diagnostic Regulation (IVDR)

2017 Regulation

In April 2017, the European Union published its Regulation on in vitro diagnostic medical devices, also known as the IVDR. The legislation became applicable in May 2022.

The IVDR establishes:

Clear obligations for economic operators
A risk-based classification system with four risk classes
Stricter control for high-risk IVDs
More transparency—through a comprehensive EU database on medical devices (EUDAMED)
A traceability system based on a unique device identifier (UDI)
Reinforced rules on clinical evidence and performance evaluation,
Strengthened post-market surveillance requirements
A specific regime for devices manufactured and used in the same health institution (‘in-house devices’)

In December 2025, the European Commission proposed targeted changes to the IVDR.

The IVDR revision is meant to:

Simplify the applicable rules
Reduce the administrative burden on manufacturers
Enhance the predictability and cost-efficiency of the certification procedure by notified bodies
Preserve a high level of public health protection and patient safety

Priority pathways for “breakthrough” and “orphan” diagnostics: provided that an expert panel confirms the fulfillment of the necessary criteria.
Stronger coordination across the EU: Competent authorities will work together when determining the classification of a device, or a category or group of devices.
- Member States should also consult relevant regulatory and advisory bodies incl. EMA and the SoHO Coordination Board.
A more flexible early scientific advice mechanism for class C/D tests, replacing the mandatory performance evaluation consultation procedure (PECP) for high-risk IVDs.
Enhanced clarity: regarding UDI assignment and registration in EUDAMED.
Digitalization: of technical documentation, conformity assessment and reports.
Regulatory sandboxes: can be set up by Member States to address unmet medical needs or providing significant clinical benefit to patients or the health system.
Less involvement of notified bodies in the conformity assessment of lower and medium risk devices.

Removal of the “no equivalent device on the market” condition: health institutions will no longer need to demostrate that no commercial alternatives exist.
In-house IVDs may be transferred to another health institution, when justified by public health or patient needs. Traceability must be ensured.
Central laboratories in the EU that manufacture and use tests exclusively for clinical trials are added to the scope.

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