New Milestones in MDR Certification
MatOrtho® is pleased to announce a significant expansion of our Medical Device Regulation (MDR) certified portfolio, marking another important milestone in our commitment to quality, regulatory excellence and patient safety.
Following MDR certification of our ReCerf Ceramic Hip Resurfacing Class III portfolio in September 2025, we have continued to progress the transition of our wider product portfolio to the MDR regulatory framework.
The MDR introduced more rigorous requirements for medical devices marketed within Europe, placing increased emphasis on clinical evidence, post-market surveillance, traceability and ongoing regulatory oversight. Successfully achieving certification across our portfolio therefore represents an important milestone for MatOrtho and reflects the considerable work undertaken across the organisation.
Expanding our MDR-certified portfolio
We are delighted to confirm that our MDR certification now encompasses:
- Adept Hip Resurfacing System – newly certified
- ReCerf Hip Resurfacing System
- Saiph Primary Knee Replacement System – newly certified
- Saiph Revision Knee Replacement System – newly certified
To date, MatOrtho has achieved a total of 16 Class III product certificates, together with one Class IIa and one Class I certificate.
This represents an important step in securing the continued availability of our established technologies while providing the regulatory foundation to support the ongoing development of the MatOrtho portfolio.
A significant milestone for Saiph Revision
We are particularly pleased to achieve certification for the Saiph Revision Knee Replacement System.
While our established product portfolios have transitioned from the previous MDD framework to MDR certification, Saiph Revision represents a new addition to our certified product portfolio and an important extension of the Saiph knee platform.
The addition of a revision solution broadens our knee offering beyond primary knee replacement and will enable MatOrtho to support a wider range of clinical needs. It represents another important step in the continued development of the Saiph portfolio and in our ambition to make our orthopaedic technologies available to more surgeons and patients.
More than implant certification
The transition to MDR extends beyond our implant systems. The associated surgical instrumentation supporting these procedures has also been successfully transitioned to MDR compliance.
Across the portfolio, this represents approximately 443 individual products, comprising approximately 192 implants and 251 instruments.
The scale of this work reflects a substantial cross-functional effort across MatOrtho, encompassing regulatory affairs, quality, clinical, engineering, operations and the wider business.
Achieving certification is not simply a regulatory milestone. It is part of the ongoing process required to ensure that our products continue to be supported by appropriate clinical evidence, robust quality processes and post-market monitoring throughout their lifecycle.
Built on a commitment to quality
These latest achievements demonstrate MatOrtho’s continued commitment to maintaining high standards across our orthopaedic portfolio.
Securing MDR certification across multiple Class III product systems reflects both the strength of our quality and regulatory processes and the dedication of the teams involved in bringing these programmes to completion.
“Achieving the latest MDR certifications represents an important milestone for MatOrtho and is the result of a tremendous collaborative effort across the business. Maintaining and expanding our portfolio under the MDR framework reinforces our commitment to quality, patient safety and ensuring our technologies remain available to the surgeons and patients who rely on them.”
Oriol Millet-Lopez, CEO
As we progress the final outstanding instrumentation approvals, our expanding MDR-certified portfolio provides a strong foundation for the next stage of MatOrtho’s development.
From established systems such as Adept and Saiph Primary, through to newer technologies including ReCerf and the extension of Saiph into revision knee replacement, these latest milestones demonstrate our continued focus on protecting proven technologies, developing our portfolio and supporting better orthopaedic care for patients worldwide.