In Vitro Diagnostic Medical Devices Regulation

02017R0746-20230311 → 02017R0746-20230320

Article 110 Transitional provisions 1. From 26 May 2022, any publication of a notification in respect of a notified body in accordance with Directive 98/79/EC shall become void. 2. Certificates issued by notified bodies in accordance with Directive 98/79/EC prior to 25 May … 349 unchanged words … subparagraph of this paragraph shall continue to be responsible for the appropriate surveillance in respect of all applicable requirements relating to the devices it has certified. 4. Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022 may continue to be made available on the market or put into service until 26 May 2025. Devices 2022, and devices lawfully placed on the market from 26 May 2022 pursuant to paragraph 3 of this Article may continue to be made available on the market or put into service until the following dates: (a) 26 May 2026, for devices referred to in paragraph 3, second subparagraph, or in paragraph 3, third subparagraph, point (a); (b) 26 May 2027, for devices referred to in paragraph 3, third subparagraph, point (b); (c) 26 May 2028, for devices referred to in paragraph 3, third subparagraph, points (c) and (d). service. 5. By way of derogation from Directive 98/79/EC, devices which comply with this Regulation may be placed on the market before 26 May 2022. 6. By way of derogation from Directive 98/79/EC, conformity assessment bodies which comply with this Regulation may be designated and notified prior to 26 May 2022. Notified bodies which are designated and notified in accordance with this Regulation may carry out the conformity assessment procedures laid down in this Regulation and issue certificates in accordance with this Regulation prior to 26 May 2022. 7. As regards devices subject to the procedures laid down in Article 48(3) and (4), paragraph 5 of this Article applies provided that the necessary appointments to the MDCG and expert panels and of EU reference laboratories have been made. 8. By way of derogation from Article 10, points (a) and (b) of Article 12(1) and Article 15(5) of Directive 98/79/EC, manufacturers, authorised representatives, importers and notified bodies which, during the period starting on the later of the dates referred to in point (f) of Article 113(3) and ending 18 months later, comply with Articles 26(3), 28(1) and 51(5) of this Regulation shall be considered to comply with the laws and regulations adopted by Member States in accordance with Article 10, points (a) and (b) of Article 12(1) and Article 15(5) of Directive 98/79/EC as specified in Decision 2010/227/EU. 9. Authorisations granted by the competent authorities of the Member States in accordance with Article 9(12) of Directive 98/79/EC shall keep the validity indicated in the authorisation. 10. Until the Commission has designated, pursuant to Article 24(2), issuing entities, GS1, HIBCC and ICCBBA shall be considered to be designated issuing entities.

02017R0746-20230311 → 02017R0746-20230320

Article 112 Repeal Without prejudice to Articles 110 (3) and (4) of this Regulation, and without prejudice to the obligations of the Member States and manufacturers as regards vigilance and 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: (a) Article 11, point (c) of Article 12(1) 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, which are 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; and (b) Article 10, points (a) and (b) of Article 12(1) 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, which are repealed with effect from 18 months after the later of the dates referred to in Article 113(2) and point (f) of Article 113(3) of this Regulation. As regards the devices referred to in Article 110(3) and (4) of this Regulation, Directive 98/79/EC shall continue to apply until 26 May 2028 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.