Manufacturers – The European Union In Vitro Diagnostics Regulation

Step by step guide to compliance for manufacturers

The manufacturer has the main role in complying with the EU MDR. Considering that both the device and the manufacturer must comply with the EU MDR, the manufacturer has by far the largest number of obligations to fulfil.

The linked pages 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.

Step by step guide to compliance for manufacturers

Step 1: Decide the intended use and classification

Step 2: Establish the necessary processes and resources

Step 3: Minimise risks and fulfil the general requirements

Step 4: Complete the performance evaluation

Step 5: Compile the technical documentation

Step 6: Make arrangements for distribution

Step 7: Register the device and the manufacturer

Step 8: Complete the conformity assessment

Step 9: Complete the final administrative procedures before launch

Step 10: Fulfil the obligations of the post market phase