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Medical Devices: Harmonisation of Requirements for Address of Manufacturer

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The inclusion of the manufacturer’s address on the labels and instructions for use is an Essential Requirement according to the regulation of medical devices.. The Central Management Committee has recently issued a decision which, in effect, harmonises this requirement and is intended to minimise any adverse impact on post market surveillance activities which may have arisen as a consequence of hitherto divergent interpretations.

Wainwright Associates offer full services in connection with the regulation of medical devices and if you would like to know what this new decision means for your products , or if you require assistance with writing your labels and instructions for use, please contact us on +44 (0)1628 530554 or email


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