MDR - Chapter X - article 118

Original text

Expert opinion

Amendment to Regulation (EC) No 178/2002

In the third paragraph of Article 2 of Regulation (EC) No 178/2002, the following point is added:

(i) medical devices within the meaning of Regulation (EU) 2017/745 of the European Parliament and of the Council.

Amendment to the food regulation

The food regulation is amended with the paragraph under i) to lay the basis for food delivered via a medical device. This actually forms the regulatory basis for food-medical device combination products.

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