NB-Med and Team-NB issued a Joint Position Paper to ensure more harmonized classification of implantable devices and long-term surgically invasive devices under the new MDR (Annex VIII, Rule 8).
Rule 8 lays down a general class risk - IIb, however with eight exceptions that fall under the highest risk class (Class III) and even those have exceptions with wording that allows (too) wide interpretation.
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