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:
- 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;
- 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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