Europe – TEAM-NB : Position Paper on Spinal Classification per the MDR

This document summarizes the opinion of NB-Med and Team-NB on rule 8 of the medical device regulation (EU) 2017/745. It was created to facilitate the discussion about the classification of implantable devices and long-term surgical invasive devices as described in the regulation and to ensure a harmonized implementation of the classification rules throughout Notified Bodies.
ANNEX VII – 5.4. – Rule 8 of the MDR includes for various neurosurgical implants unspecific wording which is not considering the establishment level of these devices and is leading to their upclassification to the highest risk class in Europe (Class III). Professional resources of a representative number of notified bodies met to clarify, discuss and agree on the interpretation of this new rule and communicate a common understanding back to the relevant EU authorities and if relevant the EU Commission.
The current position paper aims to provide a risk-based decision tree which considers the
establishment level of the various devices, their clinical evidence and the risks associated with their usage…