This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union .

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 13 November 2023.

For the Commission

The President

Ursula VON DER LEYEN

( 1 ) OJ L 396, 30.12.2006, p. 1 .

( 2 ) Commission Regulation (EU) 2021/2045 of 23 November 2021 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) ( OJ L 418, 24.11.2021, p. 6 ).

( 3 ) 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 ( OJ L 117, 5.5.2017, p. 1 ).

( 4 ) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU ( OJ L 117, 5.5.2017, p. 176 ).

( 5 ) Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices ( OJ L 189, 20.7.1990, p. 17 ).

( 6 ) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices ( OJ L 169, 12.7.1993, p. 1 ).

( 7 ) Directive 98/79/EC of the European Parliament and the Council of 27 October 1998 on in vitro diagnostic medical devices ( OJ L 331, 7.12.1998, p. 1 ).

( 8 ) Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices ( OJ L 9, 28.1.2022, p.3 ).

( 9 ) Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices ( OJ L 80, 20.3.2023, p. 24 ).

COMMISSION REGULATION (EU) 2023/2482 of 13 November 2023 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards the substance bis(2-ethylhexyl) phthalate (DEHP) in medical devices ANNEX