Medical Device Regulatory Consulting
Rule 1 to 4- Non-Invasive Devices Part 1 Classification rules have been changed for some devices in MDR. Devices shall be divided into classes I, IIa, IIb and III, by the intended purpose of the devices and their associated risks. Here I am explaining the major changes in the rules of MDR when compared to …
Continue reading "New Aspects of Classification Rules -EU MDR"
The UDI (Unique Device Identification) is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard. The affixing of the UDI is an additional requirement for labels or on the device itself, it does not replace any other marking or labelling requirements. Only the manufacturer may …
Medical Device CE Marking 