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Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. ) article 119 CELEX: 02017R0745-20250110 Amendment to Regulation (EC) No 1223/2009
In Article 2 of Regulation (EC) No 1223/2009, the following paragraph is added:
‘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).’. |