IVDR deadlines 2027-2029: the IVD transition calendar

The transition to Regulation (EU) 2017/746 (IVDR) is one of the most underestimated regulatory projects in the sector. Unlike the MDR, the IVDR moved a majority of in vitro diagnostic devices under notified body control, where self-certification previously sufficed. The result: a bottleneck, and deadlines arriving fast. Here is the exact calendar and what to do right now.

Why the IVDR changes everything for IVDs

Under the former Directive 98/79/EC (IVDD), around 80% of in vitro diagnostic devices were self-certified by the manufacturer, without notified body involvement. The IVDR reversed the logic: with the new risk-based classification (classes A, B, C, D), it is now the opposite — the majority of IVDs require notified body involvement.

The problem: the number of notified bodies designated under the IVDR remains limited, and their audit capacity is saturated. It is this observation that led the European Commission to adopt Regulation (EU) 2024/1860, extending the transition periods.

The IVDR transition calendar (Regulation 2024/1860)

The cut-off dates depend on the device's risk class:

• Class D (highest risk — HIV, hepatitis, blood donation screening): 31 December 2027
• Class C (high risk — tumour markers, genetic tests, screening): 31 December 2028
• Class B and sterile Class A (moderate risk and low risk sterile): 31 December 2029

💡 These dates assume the device was already legally on the market and that no significant change to design or intended purpose has occurred.

The conditions for benefiting from the extension

An extended deadline is not automatic. To benefit from it, the manufacturer must in particular:

1. Maintain IVDD compliance for the legacy device concerned
2. Make no significant change to the design or intended purpose
3. Have implemented a quality management system compliant with the IVDR by the scheduled date at the latest
4. File a formal application with a notified body and obtain written agreement within the deadlines set by the regulation

Failure to meet any of these conditions removes the benefit of the transition — the device must then be withdrawn from the market.

Recommended action plan for IVD manufacturers

If you manufacture or distribute IVDs, here are the priorities:

• Map your portfolio by IVDR class and identify the cut-off date for each reference
• Secure an audit slot with an IVDR notified body as early as possible — waiting lists run into months
• Build the technical documentation in line with Annexes II and III of the IVDR (performance evidence, clinical performance evaluation)
• Set up regulatory monitoring on IVDR-specific MDCG guidance and your notified body's positions

EUDAMED and the IVDR

On top of these deadlines comes the progressive obligation to register in EUDAMED (the European medical device database): actors, UDI, certificates. IVD manufacturers must integrate this obligation into their compliance schedule.

Do not miss any IVDR development

The IVDR framework keeps evolving: new MDCG guidance, notified body designations, ANSM and EMA positions. Monitoring these sources manually represents several hours a month — with the risk of missing a decisive publication.

MedQara automates this monitoring across 18 official sources, ranks each publication by criticality and generates timestamped proof of monitoring for your audits. Its regulatory AI assistant answers your IVDR questions while citing its sources.

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This article is provided for informational purposes and does not constitute regulatory advice. For any decision affecting a device, validate with your notified body or a regulatory affairs expert.