IVDR Extension: A Free Pass or a Strategic Opportunity?

The recent extension of In Vitro Diagnostic Regulation (IVDR) deadlines under (EU) 2024/1860 has led many manufacturers to breathe a sigh of relief. With additional time granted for compliance, some organizations may feel a reduced sense of urgency.

But does this extension truly mean manufacturers can afford to wait? Not exactly. While the new timelines offer flexibility, they come with specific conditions and ongoing requirements for quality management system (QMS) remediation.

Now is the time to take a strategic approach to compliance—before the deadlines become a last-minute scramble.

A Mixed Message: Compliance vs. Supply Risk

The language in the regulation’s preamble seems to shift the focus from compliance to ensuring an uninterrupted supply of medical devices:

“It is therefore necessary to ensure that there is an uninterrupted market supply of in vitro diagnostic medical devices in the Union.” (EU 2024/1860, Preamble Paragraph 9)

While supply continuity is critical, this does not mean compliance requirements have eased. The extension only applies under certain conditions, including:

• The manufacturer informs the competent authority if a supply interruption or discontinuation could result in serious harm to patients or public health.
• Devices must have had a valid EU 98/79/EC (IVDD) certificate as of May 26, 2022, and must not have been withdrawn.
• Competent authorities in EU Member States must grant a derogation from the standard conformity assessment procedure.
• No significant changes can be made to the design or intended purpose of the device.

These conditions emphasize that while time extensions exist, compliance remains non-negotiable.

Key IVDR Deadlines & Requirements

For manufacturers working toward compliance, meeting key deadlines is essential:

For organizations assuming these extensions allow for delays in compliance efforts, these dates should serve as a reality check.

Article 10: More Than Just ISO 13485 Compliance

Many manufacturers wonder: Are the Article 10 and transitional requirements the same as ISO 13485?

The answer: Not quite. While ISO 13485 forms the foundation of a compliant QMS, IVDR Article 10 includes additional specificity and requirements, such

Article 10 Requirement Description of Change Helpful Resources

This means compliance isn’t just about meeting deadlines—it’s about building a robust, future-proof QMS that supports long-term regulatory success.

Why Wait? Start Your Compliance Journey Today

While the IVDR extension grants additional time, manufacturers should act now to avoid last-minute remediation challenges. Our ready-to-go solutions, developed through successful implementations across EU and non-EU manufacturers and two Notified Bodies, help companies:

• Understand exactly what to do and when to do it
• Follow a structured remediation process to avoid unnecessary complexity
• Implement a streamlined approach to compliance—without overloading internal resources

Don’t let the extension create a false sense of security. By acting now, manufacturers can ensure compliance, risk mitigation, and business continuity—well ahead of the deadlines.

Explore our solutions today: QMS Velocity IVDR Resources