Hi,
There is advice here for class one manufacturers:
ec.europa.eu/health/medical-devices/documents/consensus-statements/index_en.htm (hyperlink dead 14.7.2016)
And if you intend to register in the UK:
mhra.gov.uk/Howweregulate/Devices/Registrationofmedicaldevices/index.htm
David
There is advice here for class one manufacturers:
ec.europa.eu/health/medical-devices/documents/consensus-statements/index_en.htm (hyperlink dead 14.7.2016)
And if you intend to register in the UK:
mhra.gov.uk/Howweregulate/Devices/Registrationofmedicaldevices/index.htm
David
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