In Vitro Diagnostic Medical Devices Regulation

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02017R0746-20230320 → 02017R0746-20240709

Article 74 Coordinated assessment procedure for performance studies 1. By means of the electronic system referred to in Article 69, the sponsor of a performance study to be conducted in more than one Member State may submit, for the purpose of Article … 1,185 unchanged words … (c) of Section 2.3.2 of Part A of Annex XIII, which shall be assessed separately by each Member State concerned. 13. The Commission shall provide administrative support to the coordinating Member State in the accomplishment of its tasks under this Chapter. 14. The All Member States shall be required to apply the procedure set out in this Article shall, until 25 May 2029, from the date corresponding to 5 years from the date of publication of the notice referred to in Article 34(3) of Regulation (EU) 2017/745, informing that the electronic system referred to in Article 30(2), point (e), of this Regulation is functional and meets the functional specifications drawn up pursuant to Article 34(1) of Regulation (EU) 2017/745. Before the date set out in the first subparagraph of this paragraph and at the earliest 6 months from the date of publication of the notice referred to in that subparagraph, the procedure set out in this Article shall be applied only by those of the Member States in which the performance studies are study is to be conducted which have agreed to apply it. From 26 May 2029, all Member States shall be required to apply that procedure.

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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 2017 shall remain valid until the end of the period indicated on the certificate, except for certificates issued in accordance with Annex VI to Directive 98/79/EC which shall become void at the latest on 27 May 2025. Certificates issued by notified bodies in accordance with Directive 98/79/EC from 25 May 2017 that were still valid on 26 May 2022 and that have not been withdrawn thereafter shall become void continue to remain valid after the end of the period indicated on the certificate until 31 December 2027. Certificates issued by 27 notified bodies in accordance with that Directive from 25 May 2025. 2017 that were still valid on 26 May 2022 and that have expired before 9 July 2024 shall be considered to be valid until 31 December 2027 only if one of the following conditions is fulfilled: (a) before the date of expiry of the certificate, the manufacturer and a notified body have signed a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII to this Regulation for the conformity assessment in respect of the device covered by the expired certificate or in respect of a device intended to substitute that device; (b) a competent authority of a Member State has granted a derogation from the applicable conformity assessment procedure in accordance with Article 54(1) of this Regulation or has required the manufacturer, in accordance with Article 92(1) of this Regulation, to carry out the applicable conformity assessment procedure. 3. By way of derogation from Article 5 and provided the conditions set out in paragraph 3c of this Regulation, the Article are met, devices referred to in the second paragraphs 3a and third subparagraphs 3b of this paragraph Article may be placed on the market or put into service until the dates set out in those subparagraphs, provided that, from the date of application of this Regulation, those devices continue to comply with Directive 98/79/EC, and provided that there are no significant changes in the design and intended purpose of those devices. paragraphs. 3a. Devices with which have a certificate that was issued in accordance with Directive 98/79/EC and which that is valid by virtue of paragraph 2 of this Article may be placed on the market or put into service until 26 May 2025. 31 December 2027. 3b. Devices for which the conformity assessment procedure pursuant to Directive 98/79/EC did not require the involvement of a notified body, for which a declaration of conformity was drawn up prior to 26 May 2022 in accordance with that Directive, and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, may be placed on the market or put into service until the following dates: (a) 26 May 2025, 31 December 2027, for class D devices; (b) 26 May 2026, 31 December 2028, for class C devices; (c) 26 May 2027, 31 December 2029, for class B devices; (d) 26 May 2027, devices and for class A devices placed on the market in sterile condition. 3c. Devices referred to in paragraphs 3a and 3b of this Article may be placed on the market or put into service until the dates referred to in those paragraphs only if the following conditions are met: (a) those devices continue to comply with Directive 98/79/EC; (b) there are no significant changes in the design and intended purpose; (c) the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health; (d) no later than 26 May 2025, the manufacturer has put in place a quality management system in accordance with Article 10(8); (e) the manufacturer or the authorised representative has lodged a formal application with a notified body in accordance with Section 4.3, first subparagraph, of Annex VII for conformity assessment in respect of a device referred to in paragraph 3a or 3b of this Article or in respect of a device intended to substitute that device, no later than: (i) 26 May 2025, for devices referred to in paragraph 3a and paragraph 3b, point (a), of this Article; (ii) 26 May 2026, for devices referred to in paragraph 3b, point (b), of this Article; (iii) 26 May 2027, for devices referred to in paragraph 3b, point (c), of this Article; (f) the notified body and the manufacturer have signed a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII no later than: (i) 26 September 2025, for devices referred to in paragraph 3a and paragraph 3b, point (a), of this Article; (ii) 26 September 2026, for devices referred to in paragraph 3b, point (b), of this Article; (iii) 26 September 2027, for devices referred to in paragraph 3b, point (c), of this Article. 3d. By way of derogation from the first subparagraph paragraph 3 of this paragraph, Article, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, and to the registration of economic operators and of devices shall apply to devices referred to in the second paragraphs 3a and third subparagraphs 3b of this paragraph, Article, instead of the corresponding requirements in Directive 98/79/EC. 3e. Without prejudice to Chapter IV and paragraph 1 of this Article, the notified body that issued the certificate referred to in the second subparagraph paragraph 3a of this paragraph Article shall continue to be responsible for the appropriate surveillance in respect of all the applicable requirements relating to the devices it has certified. certified, unless the manufacturer has agreed with a notified body designated in accordance with Article 38 that the latter shall carry out such surveillance. No later than 26 September 2025, the notified body that has signed the written agreement referred to in paragraph 3c, point (f), of this Article shall become responsible for the surveillance in respect of the devices covered by the written agreement. Where the written agreement covers a device intended to substitute a device which has a certificate that was issued in accordance with Directive 98/79/EC, the surveillance shall be conducted in respect of the device that is being substituted. The arrangements for the transfer of the surveillance from the notified body that issued the certificate to the notified body designated in accordance with Article 38 shall be clearly defined in an agreement between the manufacturer and the notified body designated in accordance with Article 38 and, where practicable, the notified body that issued the certificate. The notified body designated in accordance with Article 38 shall not be responsible for conformity assessment activities carried out by the notified body that issued the certificate. 4. Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 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. 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.11. Article 10a shall also apply to devices referred to in paragraphs 3a and 3b of this Article.

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Article 112 Repeal Without prejudice to Articles 110 (3) and 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 2022, with the exception of: (a) Article 11, Article 12(1), point (c) of Article 12(1) (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, Annexes to that Directive, which are repealed repealed, as applicable, with effect from the later of the dates date referred to in Article 113(2) 113(3), point (f), of this Regulation in respect of the application of the obligations and point (f) of requirements that relate to the electronic systems referred to in Article 113(3) 30(2), points (e) and (f), respectively, of this Regulation; and (b) Article 10, Article 12(1), points (a) and (b) of Article 12(1) (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, Annexes to that Directive, which are repealed repealed, as applicable, with effect from 18 months after the later of the dates date referred to in Article 113(2) 113(3), point (f), of this Regulation in respect of the application of the obligations and point (f) of requirements that relate to the electronic systems referred to in Article 113(3) 30(2), points (a) to (d), respectively, of this Regulation. As regards the devices referred to in Article 110(3) and 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.

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Article 113 Entry into force and date of application 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 2. It shall apply from 26 May 2022. 3. By way of derogation from paragraph 2: (a) Articles 26(3) and 51(5) shall apply from 18 months after the later of the dates referred to in point (f); (b) Articles 31 to 46 and Article 96 shall apply from 26 November 2017. However, from that date until 26 May 2022 the obligations on notified bodies pursuant to Articles 31 to 46 shall apply only to those bodies which submit an application for designation in accordance with Article 34; (c) Article 97 shall apply from 26 May 2018; (d) Article 100 shall apply from 25 November 2020; (e) for class D devices, Article 24(4) shall apply from 26 May 2023. For class B and class C devices Article 24(4) shall apply from 26 May 2025. For class A devices Article 24(4) shall apply from 26 May 2027; (f) without prejudice to the obligations on of the Commission pursuant to Article 34 of Regulation (EU) 2017/745, where, due to circumstances that could not reasonably have been foreseen when drafting the plan referred to in Article 34(1) of that Regulation, Eudamed is not fully functional on 26 May 2022, the obligations and requirements that relate to Eudamed any of the electronic systems referred to in Article 30(2) of this Regulation shall apply from the date corresponding to six 6 months after from the date of publication of the notice referred to in Article 34(3) of Regulation (EU) 2017/745, informing that the relevant electronic system is functional and meets the functional specifications drawn up pursuant to Article 34(1) of that Regulation. The provisions referred to in the preceding sentence are: Article 26, Article 28, Article 29, the second sentence of Article 36(2), Article 38(10), Article 39(2), the second subparagraph of Article 40(12), points (d) and (e) of Article 42(7), Article 49(2), Article 50(1), Article 51(5), Articles 66 to 73, paragraphs 1 Article 74(1) to 13 of (13), without prejudice to Article 74, 74(14), Articles 75 to 77, Article 81(2), Articles 82 and 83, Article 84(5) and (7) and the third subparagraph of Article 84(8), Article 85, Article 88(4), (7) and (8), Article 90(2) and (4), the last sentence of Article 92(2), Article 94(4), Article 110(3d). Until the second sentence date of application of the provisions referred to in the first subparagraph of Article 110(3). Until Eudamed is fully functional this point, the corresponding provisions of Directive 98/79/EC shall continue to apply for the purpose of meeting the obligations laid down in the provisions listed in the first paragraph of this point regarding exchange of information including, and in particular, information regarding on vigilance reporting, performance studies, vigilance reporting, registration of devices and economic operators, and certificate notifications. notifications shall continue to apply. (fa) no later than 6 months from the date set out in point (f), first subparagraph, of this paragraph, manufacturers shall ensure that the information to be entered in Eudamed in accordance with Article 26 is entered in the electronic system referred to in Article 30(2), points (a) and (b), including regarding the following devices, provided that those devices are also placed on the market from the date set out in point (f), first subparagraph, of this paragraph: (i) devices for which the manufacturer has undertaken a conformity assessment in accordance with Article 48; (ii) devices placed on the market pursuant to Article 110(3), (3a) or (3b), unless the device, for which the manufacturer has undertaken a conformity assessment in accordance with Article 48, is already registered in Eudamed; (fb) no later than 12 months from the date set out in point (f), first subparagraph, of this paragraph, notified bodies shall ensure that the information to be entered in Eudamed in accordance with Article 51(5) is entered in the electronic system referred to in Article 30(2), point (d), including regarding devices referred to in point (fa)(i) of this paragraph; for those devices, only the latest relevant certificate and, where applicable, any subsequent decision taken by the notified body related to such certificate shall be entered; (fc) by way of derogation from point (f), first subparagraph, of this paragraph, the obligations to upload the summary of safety and performance in accordance with Article 29(1) and to notify competent authorities in accordance with Article 50(1), through the electronic system referred in Article 30(2), point (d), shall apply to devices referred to in point (fa) of this paragraph when the certificate is entered in Eudamed in accordance with point (fb) of this paragraph; (fd) without prejudice to point (f), first subparagraph, of this paragraph, when a manufacturer is to submit a PSUR in accordance with Article 81(2) of this Regulation, to report a serious incident or a field safety corrective action in accordance with Article 82 of this Regulation, or to submit a trend report in accordance with Article 83 of this Regulation through the electronic system referred to in Article 30(2), point (f), of this Regulation, it shall also register the device, which is the subject of the PSUR or the vigilance reporting, in the electronic system referred to in Article 30(2), points (a) and (b), of this Regulation, except if such device was placed on the market in accordance with Directive 98/79/EC; (g) the procedure set out in Article 74 shall apply from 26 May 2029 without prejudice to Article 74(14); (h) Article 110(10) shall apply from 26 May 2019; (i) Article 5(5), points (b) and (c) and (e) to (i), shall apply from 26 May 2024; (j) Article 5(5), point (d), shall apply from 26 May 2028. 31 December 2030.