Extension of IVDR transition period

The transition period under the EU In Vitro Diagnostic Medical Devices Regulation (IVDR, EU 2017/746) was extended by the amendment EU 2024/1860, which entered into force in July 2024. However, the extension does not mean automatic extra time for all operators. It means meeting specific conditions within clearly defined deadlines.

In practice, managing the transition period is no longer a one-off project, but an ongoing process in which the manufacturer must demonstrate progress towards meeting the IVDR requirements. This directly affects market access and the availability of products in the EU.

One of the most significant changes introduced by the IVDR has been a substantial tightening of requirements, particularly in relation to demonstrating product performance, surveillance and traceability, and clinical evidence and documentation. 

At the same time, a significantly larger share of IVD devices moved into the scope of assessment by a notified body. For this reason, the transition period was not extended to ease administrative work, but to safeguard the availability of devices on the market. Only products that meet the strict conditions can benefit from the extension, in particular those relating to the quality management system, applications and agreements with a notified body.

What did the new regulation (2024/1860) change in practice?

The amendment that entered into force in July 2024 had two key effects:

Certain devices that had been placed on the market under the IVDD ([98/79/EC]()) may remain on the market for longer – but only if the manufacturer progresses towards IVDR compliance in line with the defined milestones.

The extension is not automatic; it is tied to concrete preconditions:

• an IVDR-compliant quality management system
• an application submitted to a notified body
• a written agreement with a notified body

In addition, the previously removed “sell-off” deadline reduced the mandatory withdrawal of products from the market, but it does not remove the obligations for new products or for products relying on the transitional provisions.

Who can benefit from the transition period?

The extension applies only to so-called legacy devices, i.e. products that were on the market under the IVDD before 26 May 2022, fall into Class D, C, B or Class A sterile (not Class A non-sterile), and meet the transition-period conditions throughout the entire period.

The three key conditions are:

1. The product continues to comply with the requirements and does not present an unacceptable risk
2. No significant changes are made to the product
3. The manufacturer progresses through the IVDR transition in line with the deadlines

Critical deadlines

The greatest risk is not the final date of the transition period, but missing the interim milestones. This table summarises the most critical deadlines:

If even one interim milestone is missed, the transition period can no longer be relied upon.

The most common stumbling block is change management

One of the most underestimated risks is related to change management. If the product’s intended purpose, technical solution, performance or documentation (for example, the IFU) changes in a way that is interpreted as a significant change, the right to rely on the transition period may end immediately. This makes change management a critical part of any IVDR strategy – not only as a technical matter, but also as a matter of regulatory decision-making.

What does this mean in practice for customers?

The IVDR transition period is not just a regulatory issue. It is a factor that directly affects business:

• Market access can be interrupted without prior warning
• Documentation maturity determines project lead times
• Notified body capacity creates a bottleneck

The extended transition period helps only if the manufacturer is actively progressing towards IVDR compliance. In other words, it is not wise to wait until the last minute.

How can SGS Fimko support you in this situation?

SGS Fimko acts as a notified body under the IVDR (NB 0598) and as part of the international SGS network.

SGS Fimko offers, among other things, EN ISO 13485 certification, which is often used as the foundation for an IVDR quality management system. However, it is important to understand that the certificate alone does not fulfil the IVDR requirements; it must be complemented by processes such as PMS, vigilance and registration.

The biggest challenge in the transition period is not the existence of the requirements, but how they should be interpreted for your own product.

The Structured Dialogue approach offered by SGS Fimko helps break the requirements down step by step, identify risks early and ensure that the right things are ready at the right time.

What should customers do now?

Managing the transition period is a chain in which failure at one point can undermine the whole.

At a minimum, manufacturers should make sure that:

• the product genuinely falls within the scope of the transitional provisions (legacy status)
• an IVDR-compliant quality management system is in place
• the application and agreement with the notified body are on schedule
• change management is sufficiently controlled.

Explore our IVDR services and get in touch: IVD.devices.fimko@sgs.com.