Mecuris, a spin-off of the LMU hospitals, enables physicians and orthopedic technicians to create customized prostheses and orthoses using 3D printing. The Munich-based medical technology company has now delivered the world's first 3D-printed prosthetic feet with CE marking.
Mecuris offers 3D-printed prosthetic feet for both adults and children — the first of their kind in the world. The custom-made prostheses now carry the CE mark and Mecuris This marks the start of the market launch. Carolin Taubmann from Mecuris' quality management explains the practical requirements that the prosthetic foot must meet for CE marking:
“The prosthetic foot should be able to withstand extreme loads, such as jumping down a flight of stairs, even after more than three years of wear by a very active patient.”
A custom prosthesis in 48 hours
CEO Manuel Opitz emphasizes the complexity of medical approval procedures:
"We are the first – and only – manufacturer in the world to achieve CE marking for a 3D-printed prosthetic foot. I believe our quality management has set a new record by obtaining medical approval in less than four months. The amendment to the European Medical Device Regulation (MDR) requires manufacturers to comply with CE guidelines, even for custom-made products."
Jannis Breuninger, Head of Product Development at Mecuris, talks about the production and fitting of the first prosthetic feet with CE certification:
"We fitted the two NexSteps to a patient just last week. The resulting CAD models were then produced at a certified 3D printing center in Germany and sent to us for final inspection. The feet are now being delivered to a specialist in Eastern Europe. He will fit a young and active double amputee with the two NexSteps. The patient was surprised that we delivered so quickly, as he had previously always had to wait two to three months for a new prosthesis."
The long-term goal, according to Breuninger, is to ship individually fitted prostheses within 48 hours.
