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Rongtao Medical's Insights on Ultrasound Parts Regulation

As the deadline approaches for the EUDAMED (European Database on Medical Devices) device-entry transition, a significant shift in the landscape of ultrasound parts and repair can be expected. On October 5, 2026, Rongtao Medical, a pioneering provider of ultrasound parts and repair solutions, released a comprehensive framework that elaborates on Article 23 of the EU Medical Device Regulation (MDR). This regulation is crucial for understanding how replacement parts are classified and how they must be managed in compliance with European standards.

Understanding Article 23

The MDR, consolidated on July 19, 2026, stipulates two primary routes for categorizing replacement items:
1. Identical or Similar Components: If a replacement part is provided to restore or maintain the function of a medical device without altering its performance or safety features, it retains its identity as a part. In this scenario, the supplier needs to furnish evidence confirming that the replacement does not negatively impact the device's performance and safety.
2. Significant Changes: Conversely, if the part in question introduces significant alterations to performance, safety, or intended use, it is categorized as a standalone medical device and must adhere fully to MDR requirements.

Notably, this categorization cannot be determined based solely on a part's description in a catalog or database. Instead, the documentation accompanying each shipment detailing its intended purpose is critical for compliance.

Implications for Suppliers and Buyers

With mandatory EUDAMED modules coming into play since May 28, 2026, the regulations impose rigorous verification processes on EU importers and distributors. They must ensure that all ultrasound devices, particularly probes and accessories provided as replacements, are appropriately registered and identified before distribution. While the onus is on the supplier to demonstrate compliance with Article 23, the buyers need to ensure that the replacements are functioning as per the regulatory standards in place.

Despite the advent of such regulatory frameworks, Rongtao Medical's findings underscore a significant challenge: existing registries alone cannot suffice for verifying the safety and efficacy of ultrasound replacement parts. In an extensive analysis performed on 176,223 U.S. FDA 510(k) records, they found no direct matches for ultrasound spare boards, highlighting a gap in the existing data. Hence, the clarity around device identity, configuration, and testing evidence must accompany parts to fulfill standards.

The Importance of Evidence

Frank Zhu, General Manager of Rongtao Medical, emphasized that the variances in part revisions and software dependencies often remain hidden under similar descriptions, complicating the compliance evaluation. The company's objective is to ensure that EU buyers have access to comprehensive information about the identity and testing context of supplied parts, allowing them to conduct Article 23 assessments based on tangible evidence rather than just compatibility claims.

In this context, ordinary repair-and-return practices, which do not necessitate fresh conformity assessments, are differentiated from full refurbishments, where the rebuilder assumes the role of a manufacturer under the regulation.

Conclusion

As the November 28, 2026 deadline approaches, the landscape for ultrasound parts suppliers becomes increasingly complex, demanding compliance with stringent EU regulations. Rongtao Medical's proactive framework and insights into Article 23 of the MDR represent a critical step in preparing both suppliers and buyers to navigate the upcoming changes effectively. For those in the medical imaging sector, understanding these dynamics is essential for ensuring compliance and maintaining high standards in patient care.

For a deeper dive into this subject, readers can access the full report here.

About Rongtao Medical

Rongtao Medical is based in Guangzhou, China, providing crucial support in ultrasound core board repairs, probe solutions, and the supply of replacement parts for medical imaging equipment. Their extensive service coverage spans multiple brands, underscoring their commitment to maintaining high-quality standards in the medical sector.