Europe | Medical Devices
Now that the European Medical Device Regulation (MDR) is widely available, manufacturers and other industry participants can more accurately predict key issues that will affect them—including how and whether the scope of the new regulations covers their devices.
Note: This blog post was updated in October 2018 for accuracy.
The MDR text (see page 13 for the definition) as well as its accompanying Annex XVI (page 117) lay out clear indications as to which types of devices will have to...
Source | Ronald Boumans and Stewart Eisenhart
Sep 9, 2018