United Orthopedic Receives Asia’s First EU MDR Certificate for Class III High-Risk Orthopedic Medical Device from BSI

On the 12th, United Orthopedic announced that its U Total Knee System has successfully received the first EU Medical Device Regulation (MDR) certificate for a Class III high-risk orthopedic medical device issued by BSI in all of Asia, meeting the highest international standards for product quality and safety. This achievement further motivates United Orthopedic to continue innovating and improving product quality and safety, delivering superior medical solutions to patients worldwide.

In April, United Orthopedic reported consolidated revenue of NT$479 million, representing a 27% year-on-year increase. For the first four months of the year, cumulative consolidated revenue reached NT$1.776 billion, up 23.09% from the same period last year.

United Orthopedic noted that the European Union officially adopted the MDR in 2017, replacing the previous Medical Device Directive (MDD). Implementation of the new regulation began in stages starting in 2021, with the goal of enhancing medical device safety, clinical effectiveness, and market transparency, thereby safeguarding patient rights and strengthening industry trust.

Compared to the MDD, the MDR imposes significantly more stringent requirements regarding clinical evidence, technical documentation, risk management, and post-market surveillance (PMS/PMCF). It also clearly defines the responsibilities of manufacturers, distributors, and importers, and introduces the EUDAMED information platform to improve traceability and transparency of product information. These enhancements make the certification process more complex and the compliance threshold notably higher.

United Orthopedic explained that artificial joint implants fall under the highest risk category and must undergo the strictest Class III certification. This entails comprehensive clinical trial data and a post-market clinical follow-up (PMCF) plan, with all technical and clinical documentation subject to rigorous review by a European Notified Body. The overall certification process is among the most challenging and costly, typically requiring two to three years to complete—two to three times longer than the previous MDD certification process.

BSI is recognized as one of the world’s most authoritative certification bodies. The successful CE MDR certification of the U2 Total Knee System for Class III orthopedic medical devices represents the highest level of certification difficulty in the field and is the first of its kind in Asia. This signifies that United’s product has passed thorough clinical evaluations, risk assessments, and quality control reviews, fully complying with the latest EU medical device regulations. The certification not only affirms the product’s compliance with international standards for quality and safety but also ensures its continued legal sale and use within EU member states. It enhances United Orthopedic’s global competitiveness, strengthens brand reputation and market recognition, and lays a solid foundation for future international market expansion.

Currently, United Orthopedic’s product lineup in Europe includes knee systems (U2 Total Knee System, U2 Total Knee System-Mobile, U2 Total Knee System-PSA), hip systems (U-Motion II Acetabular System, Dual Mobility System, U2 Hip Stem, UCP Stem, UTF Stem, UTS Stem, Conformity Stem), and limb reconstruction systems (USTAR II System). In addition to the recently certified U2 Total Knee System, the company expects to obtain MDR certification for its other products between 2025 and 2027, ensuring compliance with stricter regulatory standards for continued legal distribution in the EU.

Reference: United Orthopedic Receives Asia’s First EU MDR Certificate for Class III High-Risk Orthopedic Medical Device from BSI | Healthcare+ B2B