Your step by step guide to complying with the European Union's Medical Device Regulation of 2017.

 

Step 1

Decide the intended use and classification

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Step 2

Establish the necessary processes and resources

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Step 3

Minimise the risks and fulfil the general requirements

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Step 4

Complete the clinical evaluation

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Step 5

Compile the technical documentation

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Step 6

Make arrangements for distribution

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Step 7

Register the device and the manufacturer

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Step 8

Complete the conformity assessment

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Step 9

Complete the final administrative procedures before launch

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Step 10

Fulfil the ongoing obligations in the post launch phase

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