* Regulation (EU) of the European Parliament and of the Council of on 2017/… … 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 p. (OJ L …, …, …).++'. Article 118 Amendment to Regulation (EC) No 178/2002 In the third subparagraph of Article 2 of Regulation (EC) No 178/2002, the following point is added: '(i) medical devices within the meaning of Regulation (EU) of the European 2017/… Parliament and of the Council*+. __________________ * Regulation (EU) of the European Parliament and of the Council of on 2017/… … 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 (OJ L p. …, …, …).'. Article 119 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).'. Article 120 Transitional provisions 1. From [date of application of this Regulation], any publication of a notification in … respect of a notified body in accordance with Directives 90/385/EEC and 93/42/EEC shall become void.
* Regulation (EU) 2017/… of the European Parliament and of the Council of … 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 (OJ L …, …, p. …).++'. Article 118 Amendment to Regulation (EC) No 178/2002 In the third subparagraph of Article 2 of Regulation (EC) No 178/2002, the following point is added: '(i) medical devices within the meaning of Regulation (EU) 2017/… of the European Parliament and of the Council*+. __________________ * Regulation (EU) 2017/… of the European Parliament and of the Council of … 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 (OJ L …, …, p. …).'. Article 119 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).'. Article 120 Transitional provisions 1. From … [date of application of this Regulation], any publication of a notification in respect of a notified body in accordance with Directives 90/385/EEC and 93/42/EEC shall become void.
ENVI_AG(2017)602726_EN.docx