Classification chart

In keeping with a devolved approach to medical device legislation, the EU turned away from establishing a legally prescribed classification of devices. Device classification is carried out through applying a series of rules within the legislation. There is no ‘central EU authority’ which prescribes the classification of a device.

The result is a series of some six implementing rules and 18 classification rules. Add to that over two dozen different routes to CE marking, and you have a recipe for some divergence of opinion. To say nothing of some confusion.

The Priory Analysts’ Classification Chart for medical devices is designed to help you through that maze. On a single page it lays out:

•    A method of device classification
•    The ability to trace backwards through the rules to establish ‘which type of devices are like mine’?
•    Forward movement to the possible Routes to approval
•    Identifies the Rule
 
It is not, and cannot be, a replacement for the legislative text. It is an aid, from which the regulatory text may be consulted for final verification of Classification and CE marking route available.

 

Ask Priory Analysts for a full copy of the classification chart. Contact us.

 

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