Impact of the European Medical Device Regulation (MDR 2017/745) on Wrist Arthroplasty in France
Seance of wednesday 29 october 2025 (Disparition des implants articulaires du membre supérieur (hors épaule) consécutive à la réglementation européenne (MDR) sur les DMI.)
DOI number : 10.2699/efwm-yh06/emem.2025.44.03
Abstract
The implementation of the European Medical Device Regulation (MDR 2017/745) has profoundly reshaped the landscape of orthopedic implants in Europe. The increased requirements for safety, clinical data, and post-market surveillance have led many manufacturers to withdraw low-volume product lines, including implants for the hand and wrist.
Management of wrist osteoarticular disorders by prosthetic arthroplasty has now become a therapeutic niche, although it has long stimulated the creativity and innovation of many surgeons and engineers.
Today, French surgeons have access to only one total wrist replacement option: the MOTEC° prosthesis by SWEMAC, distributed by KERIMEDICAL (Medartis Group). Even more concerning, no partial resurfacing implants of the distal radius remain available, despite their usefulness in traumatic or post-traumatic situations.
Over the past five years, major American manufacturers such as Depuy, Stryker, and Integra have withdrawn their thumb, wrist, and radial head prostheses from the European market. This decision reflects both the limited financial viability of the French market and the increased regulatory complexity introduced by the MDR.
Nevertheless, the clinical outcomes reported with the MOTEC° prosthesis remain encouraging, making it the only “surviving” total wrist replacement currently available in France.
The loss of these devices, driven by economic and regulatory factors, would constitute a significant setback — depriving patients of therapeutic options and reducing their chances of functional recovery, while forcing surgeons to revert to the more traditional alternative: wrist arthrodesis.
Management of wrist osteoarticular disorders by prosthetic arthroplasty has now become a therapeutic niche, although it has long stimulated the creativity and innovation of many surgeons and engineers.
Today, French surgeons have access to only one total wrist replacement option: the MOTEC° prosthesis by SWEMAC, distributed by KERIMEDICAL (Medartis Group). Even more concerning, no partial resurfacing implants of the distal radius remain available, despite their usefulness in traumatic or post-traumatic situations.
Over the past five years, major American manufacturers such as Depuy, Stryker, and Integra have withdrawn their thumb, wrist, and radial head prostheses from the European market. This decision reflects both the limited financial viability of the French market and the increased regulatory complexity introduced by the MDR.
Nevertheless, the clinical outcomes reported with the MOTEC° prosthesis remain encouraging, making it the only “surviving” total wrist replacement currently available in France.
The loss of these devices, driven by economic and regulatory factors, would constitute a significant setback — depriving patients of therapeutic options and reducing their chances of functional recovery, while forcing surgeons to revert to the more traditional alternative: wrist arthrodesis.