IVDR Compliance in 2026: What Has Changed and What You Should Do Next

The In Vitro Diagnostic Regulation (IVDR) has been on the minds of IVD manufacturers and organizations for some time. However, in 2026, it is no longer something you can plan for later. IVDR is here, and it is already reshaping how IVD manufacturers operate in Europe.

If you are feeling the pressure, you are not alone. Many companies are still working through what IVDR truly means for their products, timelines, and internal resources.

What’s different?

Under the old regulatory system, many IVDs could be self‑certified. That is no longer the case. Moving forward, most devices require review by a notified body, and expectations for clinical and performance evidence are significantly higher.

Challenges companies are facing:

Even well‑prepared organizations are encountering difficulties, including:

• Notified body delays: There are not enough notified bodies available to manage demand efficiently.
• Gaps in clinical evidence: Many legacy products were not developed to meet current IVDR requirements.
• Reclassification: Some devices have moved into higher risk classes, introducing additional requirements that were not originally planned for.

How SGS can help:

SGS supports manufacturers at every stage of IVDR compliance, from identifying regulatory gaps to preparing for certification.

Final thought:

IVDR can feel overwhelming, especially when everything requires attention at the same time. However, by breaking the process into manageable steps such as gap assessment, Stage 1, and Stage 2 audits, achieving IVDR certification can be both structured and achievable.