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The European Union Medical Device Regulation (MDR) up-classifies certain spinal implants from Class IIb to Class III. This position paper, sponsored by the Orthopaedic Surgical Manufacturers Association (OSMA), reflects on the proposed interpretation of the MDR’s risk-classification rules under MDCG 2021-24. The paper notes that the new rules create unnecessary burdens for orthopedic manufacturers and Notified Bodies during the implementation of the MDR, are inappropriate for certain implants and may lead to consequences for various stakeholders, including patients. OSMA also highlights the implants impacted and provides a brief background on device classification based on risk and its interpretation.
Spine industry professionals will benefit from this deeper understanding of the EU’s regulatory changes.
