When registering a new Device containing in its composition substances (substances being CMR of category 1A or 1B / substances having endocrine-disrupting properties/ substances which, if used separately, may be considered to be a medicinal product/ substances which, if used separately, may be considered to be a medicinal product derived from human blood or human plasma), Manufacturer will have to submit the details of those substances. Field stores the INN value for the substance provided. INN can be provided only for CMR or Endocrine-disrupting substances which, if used separately, may be considered to be a medicinal product or substances which, if used separately, may be considered to be a medicinal product derived from human blood or human plasma.

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