Article 112

Without prejudice to Article 110(3) to (4) of this Regulation, and without prejudice to the obligations of the Member States and manufacturers as regards vigilance and to the obligations of manufacturers as regards the making available of documentation, under Directive 98/79/EC, that Directive is repealed with effect from 26 May 2022, with the exception of:

1. (a)

   Article 11, Article 12(1), point (c), and Article 12(2) and (3) of Directive 98/79/EC, and the obligations relating to vigilance and performance studies provided for in the corresponding Annexes to that Directive, which are repealed, as applicable, with effect from the date referred to in Article 113(3), point (f), of this Regulation in respect of the application of the obligations and requirements that relate to the electronic systems referred to in Article 30(2), points (e) and (f), respectively, of this Regulation;

2. (b)

   Article 10, Article 12(1), points (a) and (b), and Article 15(5) of Directive 98/79/EC, and the obligations relating to registration of devices and economic operators, and certificate notifications provided for in the corresponding Annexes to that Directive, which are repealed, as applicable, with effect from the date referred to in Article 113(3), point (f), of this Regulation in respect of the application of the obligations and requirements that relate to the electronic systems referred to in Article 30(2), points (a) to (d), respectively, of this Regulation.

As regards the devices referred to in Article 110(3) to (4) of this Regulation, Directive 98/79/EC shall continue to apply to the extent necessary for the application of those paragraphs.

Decision 2010/227/EU adopted in implementation of Directives 90/385/EEC, 93/42/EEC and 98/79/EC shall be repealed with effect from the later of the dates referred to in Article 113(2) and point (f) of Article 113(3) of this Regulation.

References to the repealed Directive shall be understood as references to this Regulation and shall be read in accordance with the correlation table laid down in Annex XV.