剛剛，在歐盟官網(wǎng)看到一篇有關(guān)制造商按照MDR辦理醫(yī)療器械CE認(rèn)證的指引文件，寫的非常簡明。在此分享給大家。
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 1: Decide the intended use and classification
Step 2: Establish the necessary processes and resources
Step 3: Minimise the risks and fulfil the general requirements
Step 4: Complete the clinical 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
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