Attention, time is running out for IVDs! Even despite the proposal!
The European in-vitro diagnostics industry continues to undergo significant regulatory transition in 2026. The In Vitro Diagnostics Regulation (IVDR, EU 2017/746) is progressively replacing the former IVDD introducing substantial changes to device classification, performance evaluation, post-market surveillance, and conformity assessment requirements. At the same time, on 16 December 2025, the EU Commission presented a comprehensive legislative proposal aimed at simplifying regulatory framework of the MDR and IVDR, in order to address system bottlenecks and strengthen innovative capacity. However, it is important to note that this reform proposal does not amend or extend the IVDR transitional periods.
IVDR transitional periods – current status 2026
The currently applicable transitional periods for in vitro diagnostic medical devices do not derive from the recent reform proposal, but from Commission Regulation (EU) 2024/1860 amending Regulation (EU) 2017/746 , which entered into force on 9 July 2024. This amending regulation significantly extended the transition periods for so-called legacy devices in order to mitigate potential supply shortages within the European healthcare system.
- No extended transitional period applies to non-sterile Class A devices. Sterile Class A devices benefit from a transitional period for placing on the market until 31 December 2029.
- For Class B devices, the transitional period applies until 31 December 2029.
- For Class C devices, the transitional period ends on 31 December 2028.
- For Class D, the transition period ends on 31 December 2027.
However, the applicability of these transitional periods is subject to specific regulatory conditions:
- Manufacturers must have submitted (or submit), a formal application to the notified body for conformity
- For Class D devices, the application had to be submitted by 26 May 2025
- For Class C devices, the application must be submitted by 26 May 2026 and
- For Class A sterile and B by 26 May 2027.
- Within four months after submission of the application, a written agreement (contract) with the notified body must be concluded.
What does the IVDR Proposal 2025 envisage, and what is the associated timeline?
The proposal (EUR-Lex – 52025PC1023 – EN – EUR-Lex) addresses key systemic bottlenecks. The EU Commission aims to simplify and digitalise and further risk-adapt regulatory processes. Manufacturers are intended to benefit from reduced administrative burden through simplified documentation requirements and the increased use of digital procedures. For example, a risk-based, periodic review by notified bodies is proposed to replace the current five-year recertification cycle. Furthermore, a more flexible framework for the PRRC (Person Responsible for Regulatory Compliance) is envisaged, which is expected to particularly benefit small and medium-sized enterprises (SMEs).
In the first half of 2026, the EU Council and Parliament are expected to examine the proposal, submit amendments and establish their initial political positions. During the second half of the year, trilogue negotiations between the Council, the Parliament, and the European Commission are anticipated, with the objective of agreeing on a common legislative text. Formal adoption and publication in the Official Journal of the European Union are expected in early 2027, after which the implementation phase would begin. However, it remains uncertain whether this timeline will be accelerated due to the pressure to relief or potentially delayed by external factors.
What is the current status of notified bodies under the IVDR and the associated conformity assessment procedures?
Under the IVDD, significantly fewer conformity assessments for in vitro diagnostic medical devices required the involvement of a notified body. As a result, the number of notified bodies designated to perform conformity assessments under the (EU) 2017/746 has historically remained limited. However, the situation has gradually improved. At present, 19 notified bodies are designated to carry out conformity assessment procedures under the (EU) 2017/746 (EUROPA – European Commission – Growth – Regulatory policy – SMCS).
What experience has been gained so far regarding the designated laboratories under the IVDR for Class D devices?
Since 1 October 2024, the first EU reference laboratories (EURLs) have become operational, including the Paul Ehrlich Institute (covering hepatitis/retroviruses and respiratory viruses) (EU reference laboratories (EURLs) – Public Health – European Commission). The categories “Parasites” and “Blood group markers” are scheduled to become operational on 1 May 2026. The responsibilities of these laboratories include performance testing, batch testing and scientific advice. With the integration of reference laboratories into the conformity assessment processes, longer procedural timelines are expected due to additional testing bodies and potential capacity constraints. Moreover, the requirements for reference materials will also be stringent, and the characterisation of these materials will need to be included as part of the analytical performance assessment.
General status – where does the industry currently stand?
According to the MedTech Europe Survey of 2024 (mte_report_ivdr_mdr_2024-v7.pdf), 79% of the IVD manufacturers participating in the survey had already transitioned part of their product portfolio to the IVDR. In total, 73 IVD manufacturer organisations took part in the survey, with an approximately equal distribution between large companies and SMEs. Based on the European sales and MedTech Europe’s estimates of the size of the European medtech market, the survey covered roughly 50–70 % of the market share in the IVD sector. Among the participating organisations were six notified bodies (out of a total of twelve designated at that time).
2026 is a key year: manufacturers must actively make use of the transitional periods, advance their conformity assessments and at the same time prepare for the regulatory relief promised by the EU reform package – but there is no room for complacency. The IVDR remains demanding – even though the proposed amendments promise better predictability, reduced bureaucracy and a sustainable easing of systemic bottlenecks. However, the December 2025 proposal has not yet been adopted and the transitional periods adopted in 2024 remain in force.
