Essentials of European Medical Device Regulatory Affairs

CE mark – Annex XII

In accordance with Article 17 of 93/42/EEC the device or sterile pack (where practicable), the sales pack and the instructions for use must show the CE mark: Not less than 5mm high and must be proportional.

5mm

If CE marked using Annex II, IV, V and VI it should be accompanied by the responsible NB number e.g. 0050 for NSAI. minimum size (i.e., 5 mm) of the CE. The requirements for the size of the NB identification number is not included in Annex XII, but NBs interpret the requirements for size as half the height of the ¨ CE. ¨

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Module 7 Clinical MDR Chapter VI Clinical evaluation and clinical investigations

with MDD notes

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