Essentials of European Medical Device Regulatory Affairs

MDR-Classification Annex VIII

• 22 rules (4 extra versus MDD)

• Rule 11 software

• Rule 19 nanomaterials

• Rule 20 All invasive devices with respect to body orifices, other than surgically invasive devices, which are intended to administer medicinal products by inhalation • Rule 21 Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body

• Review your product under MDD and MDR. Plan for any change.

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Standalone Software - current

• Rules 9, 10,11 and 12 on active devices need to be reviewed • Current no specific rule for software in MDD