MDR - Annex II - article 1.2

Original text

Expert opinion

Reference to previous and similar generations of the device

(a) an overview of the previous generation or generations of the device produced by the manufacturer, where such devices exist;

(b) an overview of identified similar devices available on the Union or international markets, where such devices exist.

References to previous versions and competitor’s similar products should be made.

a) previous generations of the device, if existent, is interesting to understand the improvements and risk mitigations of a device.

b) similar devices by competitors are of interest to the authorities to understand the risks involved with the device.

Please be informed and adviced that such devices should be included for post-market surveillance and product safety update reporting. Further, the similar products of the competitor’s should be monitored via public information to be alerted in cases of field actions.

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