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Full text of EU MDR (Medical Device Regulation)
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EU MDR Chapter 10 Article 119

Article 119 – Amendment to Regulation (EC) No 1223/2009

In Article 2 of Regulation (EC) No 1223/2009, the following paragraph is added:

  1. ‘4.The Commission may, at the request of a Member State or on its own initiative, adopt the necessary measures to determine whether or not a specific product or group of products falls within the definition ‘cosmetic product’. Those measures shall be adopted in accordance with the regulatory procedure referred to in Article 32(2).’.
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