How to comply with the EU-MDR – EU MDR

If you are going to claim compliance with the EU-MDR there is no real alternative to becoming familiar with it one's self.

That said, this short guide is intended to help along the road to compliance. Those already familiar with the MDD will notice many similarities but also differences.

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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