The transition from the In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR) recently entered a new phase for manufacturers of legacy IVDs. By 26 May 2026, manufacturers of class C IVDs were required to apply to a notified body for conformity assessment of their device according to the IVDR. An agreement with the notified body must be signed by 26 September 2026.
Timelines for transitioning legacy devices to the IVDR are dependent on the risk class of the device. For high-risk IVDs – class D devices – the deadline for submission of an application to a notified body for conformity assessment was in May 2025. Manufacturers of class B and class A sterile devices have until 26 May 2027 for their application. Legacy devices can be placed on the market or put into service until the end of 2027 (class D), 2028 (class C) or 2029 (class B and also class A sterile devices) provided the conditions of the transition period described in the IVDR are met.
What does it mean for the manufacturer to prepare a technical documentation compliant with the IVDR? This regulation introduces significantly stricter requirements, including:
· A risk-based classification system (classes A-D) replacing the old list-based categorisation of IVDs
· A large increase in devices requiring notified body involvement
· Enhanced requirements for clinical evidence and performance evaluation
· More stringent post-market surveillance requirements
These stricter requirements are reflected in the extent of technical documentation now needed for demonstrating compliance. The life cycle approach in the IVDR also brings with it higher demands on continual monitoring and improvement cycles to ensure ongoing safety and conformity.
A gap analysis between the IVDD-compliant technical documentation and the IVDR will highlight any missing data and additional testing required. An overhaul of the documentation may then be necessary to bring it in line with the new requirements. As well as substantial updates to existing documents covering risk management and performance evaluation, new documents relating to, for example, UDI and PMS, are now also required. The time and effort needed to upgrade the technical documentation can be substantial.
Recent survey results from the European Commission show that many notified bodies experience manufacturers requesting a delay in the submission of technical documentation to be reviewed. This can have a knock-on effect on notified bodies’ schedules, putting on-time transition completion at risk. The message is clear: submission of a robust technical documentation according to agreed timelines is the best approach for a smooth and efficient transition to the IVDR.
Are you an IVD manufacturer and would you like more information on how we can help with your transition to the IVDR? Please contact us at [email protected]
