Combination Products

In Europe combination products are health products which combine a medicinal product with a medical device (MD). However, a combination product has only one status: medicinal product or MD.

The status of your combination products are determined by their primary mode of action (PMOA).

There are two cases:

  1. If the active ingredient is present ancillary, in order to assist the MD  in its function, the combination products have the status of a MD and must be CE marked;
  2. If the active ingredient is the primary and is assisted in its function by the MD, the combination products have medicinal product status and must obtain marketing authorisation (MA).

WHITE-TILLET advises and assists you to determine the status of your product or will assist you with the authorities to do it.

When medical device

When medicinal product


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