A step by step guide to compliance
The manufacturer has the main role in complying with the EU IVDR. Considering that both the device and the manufacturer must comply with the EU IVDR, the manufacturer has by far the largest number of obligations to fulfil.
The pages linked below describe a step by step approach to compliance which should be applicable to the majority of manufacturers and devices. There is no single formula however, and the described approach will likely require adjusting to the specifics of the manufacturer and device concerned.