New regulations ahead

MDR brings changes

New european regulations are set to come into effect on 1 January 2021. Depending on the country specific implementation, that will affect treatment with mechatronic knee joints such as the Kenevo, C-Leg, Genium and Genium X3, and other products. For O&P professionals, this means changes in terms of lifetime of and subsequent treatment with new prostheses as well as those already on the market. In the video, experts discuss aspects that need to be considered under the new regulations with respect to the (subsequent) prosthesis for amputees, with focus on the German speaking markets.

“The new regulations based on the EU Medical Device Regulation impact the day-to-day work of orthopaedics businesses because they will lead to changes in the treatment process. Our employees help you make the best preparations for future fittings now and are there to support you with advice and assistance.”

Dr Thomas Meininghaus, Vice President Global Regulatory Affairs at Ottobock

Video highlights

View the expert discussion to learn what’s behind the new regulation and get the latest information: What impact will the MDR have on subsequent prostheses with mechatronic knee joints? What other products are affected? What does this mean for users and their prosthetic fittings? What opportunities does this present?

The discussion includes

  • Matthias Regenhardt, Market Manager Prosthetics at Otto Bock HealthCare Deutschland GmbH
  • Tim Baumeister, qualified O&P professional at Pohlig GmbH
  • Josef, who wears a prosthesis with a mechatronic knee joint

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