Reclassification of Spinal Implants via Rule 8 (EU 2017/745)

Bonebuilder

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#1
Hi,

Does anyone have any information on the current situation regarding the reclassification of spinal implants under Rule 8 of the Medical Device Regulation (EU) 2017/745

Has a definition of "Spinal Column" been arrived at?

Is it only the bony vertebra or does it include the vertebra and the disc's?

The exceptions list "screws" does anyone know if thats going to include pedicle screws?

and what do people interpret a "spinal wedge" to be? Also listed as an exception or is it just a lazy cut and paste typo brought down from the total or partial joint replacements listing?
 
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