Medical Devices Regulation

No text on either side: this unit was named by a signal that carries no text, and only the structural diff carries any.

02017R0745-20230320 → 02017R0745-20240709

Article 34 Functionality of Eudamed 1. The Commission shall, in collaboration with the MDCG, draw up the functional specifications for Eudamed. The Commission shall draw up a plan for the implementation of those specifications by 26 May 2018. That plan shall seek to ensure that Eudamed is fully functional at a date that allows the Commission to publish the notice referred to in paragraph 3 of this Article by 25 March 2021 and that all other relevant deadlines laid down in Article 123 of this Regulation and in Article 113 of Regulation (EU) 2017/746 are met. 2. The Commission shall, shall inform the MDCG when, on the basis of an independent audit report, inform the MDCG when reports, it has verified that Eudamed has achieved full functionality one or more of the electronic systems referred to in Article 33(2) are functional and Eudamed meets meet the functional specifications drawn up pursuant to paragraph 1. 1 of this Article. 3. The Commission shall, after consultation with the MDCG and when it is satisfied that the conditions referred to in paragraph 2 have been fulfilled, publish a notice to that effect in the Official Journal of the European Union.

02017R0745-20230320 → 02017R0745-20240709

Article 78 Coordinated assessment procedure for clinical investigations 1. By means of the electronic system referred to in Article 73, the sponsor of a clinical investigation to be conducted in more than one Member State may submit, for the purpose of Article … 1,166 unchanged words … 4.2, 4.3 and 4.4 of Chapter II of Annex XV, 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 2027, from the date corresponding to 5 years from the date of publication of the notice referred to in Article 34(3), informing that the electronic system referred to in Article 33(2), point (e), is functional and meets the functional specifications drawn up pursuant to Article 34(1). 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 clinical investigation is to be conducted which have agreed to apply it. From 26 May 2027, all Member States shall be required to apply that procedure.

02017R0745-20230320 → 02017R0745-20240709

Article 120 Transitional provisions 1. From 26 May 2021, 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. 2. Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC … 1,550 unchanged words … reporting of serious adverse events and device deficiencies shall be carried out in accordance with this Regulation. 12. Until the Commission has designated, pursuant to Article 27(2), issuing entities, GS1, HIBCC and ICCBBA shall be considered to be designated issuing entities.13. Article 10a shall also apply to devices referred to in paragraphs 3a and 3b of this Article.

02017R0745-20230320 → 02017R0745-20240709

Article 122 Repeal Without prejudice to Article 120(3) to (3e) and (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 Directives 90/385/EEC and 93/42/EEC, those Directives are repealed with effect from 26 May 2021, with the exception of: Articles 8 and 10, Article 10b(1), points (b) and (c) of Article 10b(1), (c), and Article 10b(2) and Article 10b(3) (3) of Directive 90/385/EEC, and the obligations relating to vigilance and clinical investigations provided for in the corresponding Annexes, which are repealed with effect from the later of the dates referred to in point (d) of Article 123(3) of this Regulation; Article 10a, point (a) of Article 10b(1) and Article 11(5) of Directive 90/385/EEC, and the obligations relating to registration of devices and economic operators, and to 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 point (d) of Article 123(3) of this Regulation; Article 10, Article 14a(1), points (c) and (d) of (d), Article 14a(1), Article 14a(2), Article 14a(3) 14a(2) and (3) and Article 15 of Directive 93/42/EEC, and the obligations relating to vigilance and clinical investigations provided for in the corresponding Annexes, Annexes to those Directives, which are repealed repealed, as applicable, with effect from the later of the dates date referred to in Article 123(3), point (d) (d), of this Regulation in respect of the application of the obligations and requirements that relate to the electronic systems referred to in Article 123(3) 33(2), points (e) and (f), respectively, of this Regulation; Article 10a, Article 10b(1), point (a), and Article 11(5) of Directive 90/385/EEC, Article 14(1) and (2), Article 14a(1), points (a) and (b) of Article 14a(1) (b), and Article 16(5) of Directive 93/42/EEC, and the obligations relating to registration of devices and economic operators, and to certificate notifications, provided for in the corresponding Annexes, Annexes to those Directives, which are repealed repealed, as applicable, with effect from 18 months after the later of the dates date referred to in Article 123(3), point (d) (d), of this Regulation in respect of the application of the obligations and requirements that relate to the electronic systems referred to in Article 123(3) 33(2), points (a) to (d), respectively, of this Regulation; and Article 9(9) of Directive 90/385/EEC and Article 11(13) of Directive 93/42/EEC, which are repealed with effect from 24 April 2020. As regards the devices referred to in Article 120(3) to (3e) and (4) of this Regulation, the Directives referred to in the first paragraph of this Article shall continue to apply to the extent necessary for the application of those paragraphs. Notwithstanding the first paragraph, Regulations (EU) No 207/2012 and (EU) No 722/2012 shall remain in force and continue to apply unless and until repealed by implementing acts adopted by the Commission pursuant to this Regulation. References to the repealed Directives shall be understood as references to this Regulation and shall be read in accordance with the correlation table laid down in Annex XVII to this Regulation.

02017R0745-20230320 → 02017R0745-20240709

Article 123 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 2021. 3. By way of derogation from paragraph 2: (a) Articles 35 to 50 shall apply from 26 November 2017. However, from that date until 26 May 2021, the obligations on notified bodies pursuant to Articles 35 to 50 shall apply only to those bodies which submit an application for designation in accordance with Article 38; (b) Articles 101 and 103 shall apply from 26 November 2017; (c) Article 102 shall apply from 26 May 2018; (d) without prejudice to the obligations on of the Commission pursuant to Article 34, where, due to circumstances that could not reasonably have been foreseen when drafting the plan referred to in Article 34(1), Eudamed is not fully functional on 26 May 2021, the obligations and requirements that relate to Eudamed any of the electronic systems referred to in Article 33(2) 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). 34(3), informing that the relevant electronic system is functional and meets the functional specifications drawn up pursuant to Article 34(1). The provisions referred to in the preceding sentence are: Article 29, Article 31, Article 32, Article 33(4), the second sentence of Article 40(2), Article 42(10), Article 43(2), the second subparagraph of Article 44(12), points (d) and (e) of Article 46(7), Article 53(2), Article 54(3), Article 55(1), Article 56(5), Articles 70 to 77, paragraphs 1 Article 78(1) to 13 of (13), without prejudice to Article 78, 78(14), Articles 79 to 82, Article 86(2), Articles 87 and 88, Article 89(5) and (7), and the third subparagraph of Article 89(8), Article 90, Article 93(4), (7) and (8), Article 95(2) and (4), the last sentence of Article 97(2), Article 99(4), Article 120(3d). Until Eudamed is fully functional, the date of application of the provisions referred to in the first subparagraph of this point, the corresponding provisions of Directives 90/385/EEC and 93/42/EEC 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, clinical investigations, registration of devices and economic operators, and certificate notifications. notifications shall continue to apply. (e) no later than 12 months from the date of publication of the notice referred to in Article 29(4) 34(3) in respect of the electronic system referred to in Article 33(2), points (a) and (b), manufacturers shall ensure that the information to be entered in Eudamed in accordance with Article 29 is entered in that electronic system, including regarding the following devices, provided that those devices are also placed on the market from 6 months from the date of publication of that notice: (i) devices, other than custom-made devices, for which the manufacturer has undertaken a conformity assessment in accordance with Article 52; (ii) devices, other than custom-made devices, placed on the market pursuant to Article 120(3), (3a) or (3b), unless the device, for which the manufacturer has undertaken a conformity assessment in accordance with Article 52, is already registered in Eudamed; (ea) no later than 18 months from the date of publication of the notice referred to in Article 34(3) in respect of the electronic system referred to in Article 33(2), point (d), notified bodies shall ensure that the information to be entered in Eudamed in accordance with Article 56(5) shall apply from 18 months after the later of the dates is entered in that electronic system, including regarding devices referred to in point (d); (e)(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; (eb) by way of derogation from point (d), first subparagraph, of this paragraph, the obligations to upload the summary of safety and clinical performance in accordance with Article 32(1) and to notify competent authorities in accordance with Article 55(1), through the electronic system referred in Article 33(2), point (d), shall apply to devices referred to in point (e) of this paragraph when the certificate is entered in Eudamed in accordance with point (ea) of this paragraph; (ec) without prejudice to point (d), first subparagraph, of this paragraph, when a manufacturer is to submit a PSUR in accordance with Article 86(2) of this Regulation, to report a serious incident or a field safety corrective action in accordance with Article 87 of this Regulation, or to submit a trend report in accordance with Article 88 of this Regulation through the electronic system referred to in Article 33(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 33(2), points (a) and (b), of this Regulation, except if such device was placed on the market in accordance with Directive 90/385/EEC or 93/42/EEC; (f) for implantable devices and for class III devices Article 27(4) shall apply from 26 May 2021. For class IIa and class IIb devices Article 27(4) shall apply from 26 May 2023. For class I devices Article 27(4) shall apply from 26 May 2025; (g) with regard to reusable devices that are required to bear the UDI carrier on the device itself, Article 27(4) shall apply to: (i) implantable devices and class III devices from 26 May 2023; (ii) class IIa and class IIb devices from 26 May 2025; (iii) class I devices from 26 May 2027; (h) The procedure set out in Article 78 shall apply from 26 May 2027, without prejudice to Article 78(14); (i) Article 120(12) shall apply from 26 May 2019; (j) Article 59 shall apply from 24 April 2020.