Medical Devices Regulation

02017R0745-20170505 → 02017R0745-20200424

Article 1 Subject matter and scope 1. This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union. This Regulation also applies to clinical investigations concerning such medical devices and accessories conducted in the Union. 2. This Regulation shall also apply, as from the date of application of common specifications adopted pursuant to Article 9, to the groups of products without an intended medical purpose that are listed in Annex XVI, taking into account the state of the art, and in particular existing harmonised standards for analogous devices with a medical purpose, based on similar technology. The common specifications for each of the groups of products listed in Annex XVI shall address, at least, application of risk management as set out in Annex I for the group of products in question and, where necessary, clinical evaluation regarding safety. The necessary common specifications shall be adopted by 26 May 2020. 2021. They shall apply as from six months after the date of their entry into force or from 26 May 2020, 2021, whichever is the latest. Notwithstanding Article 122, Member States' measures regarding the qualification of the products covered by Annex XVI as medical devices pursuant to Directive 93/42/EEC shall remain valid until the date of application, as referred to in the first … 1,204 unchanged words … press or the freedom of expression in the media in so far as those freedoms are guaranteed in the Union and in the Member States, in particular under Article 11 of the Charter of Fundamental Rights of the European Union.

02017R0745-20170505 → 02017R0745-20200424

Article 17 Single-use devices and their reprocessing 1. Reprocessing and further use of single-use devices may only take place where permitted by national law and only in accordance with this Article. 2. Any natural or legal person who reprocesses a single-use device to … 353 unchanged words … the external reprocessor complies with the requirements referred to in points (a) and (b) of paragraph 3. 5. The Commission shall adopt, in accordance with Article 9(1), the necessary CS referred to in point (b) of paragraph 3 by 26 May 2020. 2021. Those CS shall be consistent with the latest scientific evidence and shall address the application of the general requirements on safety and performance laid down in in this Regulation. In the event that those CS are not adopted by 26 May 2020, 2021, reprocessing shall be performed in accordance with any relevant harmonised standards and national provisions that cover the aspects outlined in point (b) of paragraph 3. Compliance with CS or, in the absence of CS, with any relevant harmonised standards and national provisions, shall be certified by a notified body. 6. Only single-use devices that have been placed on the market in accordance with this Regulation, or prior to 26 May 2020 2021 in accordance with Directive 93/42/EEC, may be reprocessed. 7. Only reprocessing of single-use devices that is considered safe according to the latest scientific evidence may be carried out. 8. The name and address of the legal or natural person referred to in paragraph 2 and the other relevant information referred to in Section 23 of Annex I shall be indicated on the label and, where applicable, in the instructions for use of the reprocessed device. The name and address of the manufacturer of the original single-use device shall no longer appear on the label, but shall be mentioned in the instructions for use of the reprocessed device. 9. A Member State that permits reprocessing of single-use devices may maintain or introduce national provisions that are stricter than those laid down in this Regulation and which restrict or prohibit, within its territory, the following: (a) the reprocessing of single-use devices and the transfer of single-use devices to another Member State or to a third country with a view to their reprocessing; (b) the making available or further use of reprocessed single-use devices. Member States shall notify the Commission and the other Member States of those national provisions. The Commission shall make such information publicly available. 10. The Commission shall by 27 May 2024 draw up a report on the operation of this Article and submit it to the European Parliament and to the Council. On the basis of that report, the Commission shall, if appropriate, make proposals for amendments to this Regulation.

02017R0745-20170505 → 02017R0745-20200424

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 2020 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, on the basis of an independent audit report, inform the MDCG when it has verified that Eudamed has achieved full functionality and Eudamed meets the functional specifications drawn up pursuant to paragraph 1. 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.

02017R0745-20170505 → 02017R0745-20200424

Article 59 Derogation from the conformity assessment procedures 1. By way of derogation from Article 52, 52 of this Regulation or, for the period from 24 April 2020 to 25 May 2021, by way of derogation from Article 9(1) and (2) of Directive 90/385/EEC or from Article 11(1) to (6) of Directive 93/42/EEC, any competent authority may authorise, on a duly justified request, the placing on the market or putting into service within the territory of the Member State concerned, of a specific device for which the applicable procedures referred to in that Article those Articles have not been carried out but use of which is in the interest of public health or patient safety or health. 2. The Member State shall inform the Commission and the other Member States of any decision to authorise the placing on the market or putting into service of a device in accordance with paragraph 1 where such authorisation is granted for use other than for a single patient. The Member State may inform the Commission and the other Member States of any authorisation granted in accordance with Article 9(9) of Directive 90/385/EEC or Article 11(13) of Directive 93/42/EEC before 24 April 2020. 3. Following a notification pursuant to paragraph 2 of this Article, the Commission, in exceptional cases relating to public health or patient safety or health, may, by means of implementing acts, extend for a limited period of time the validity of an authorisation granted by a Member State in accordance with paragraph 1 of this Article or, when granted before 24 April 2020, in accordance with Article 9(9) of Directive 90/385/EEC or Article 11(13) of Directive 93/42/EEC to the territory of the Union and set the conditions under which the device may be placed on the market or put into service. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3). On duly justified imperative grounds of urgency relating to the health and safety of humans, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 114(4).

02017R0745-20170505 → 02017R0745-20200424

Article 113 Penalties The Member States shall lay down the rules on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate, and dissuasive. The Member States shall notify the Commission of those rules and of those measures by 25 February 2020 2021 and shall notify it, without delay, of any subsequent amendment affecting them.

02017R0745-20170505 → 02017R0745-20200424

Article 120 Transitional provisions 1. From 26 May 2020, 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 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 4 to Directive 90/385/EEC or Annex IV to Directive 93/42/EEC which shall become void at the latest on 27 May 2022. Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC from 25 May 2017 shall remain valid until the end of the period indicated on the certificate, which shall not exceed five years from its issuance. They shall however become void at the latest on 27 May 2024. 3. By way of derogation from Article 5 of this Regulation, a device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2020 2021 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, or which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of paragraph 2 of this Article, may be placed on the market or put into service until 26 May 2024, provided that from 26 May 2020 2021 it continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose. However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives. Without prejudice to Chapter IV and paragraph 1 of this Article, the notified body that issued the certificate referred to in the first subparagraph shall continue to be responsible for the appropriate surveillance in respect of all of the applicable requirements relating to the devices it has certified. 4. Devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to 26 May 2020, 2021, and devices placed on the market from 26 May 2020 2021 pursuant to paragraph 3 of this Article, may continue to be made available on the market or put into service until 26 May 2025. 5. By way of derogation from Directives 90/385/EEC and 93/42/EEC, devices which comply with this Regulation may be placed on the market prior to 26 May 2020. 2021. 6. By way of derogation from Directives 90/385/EEC and 93/42/EEC, conformity assessment bodies which comply with this Regulation may be designated and notified prior to 26 May 2020. 2021. 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 2020. 2021. 7. As regards devices subject to the consultation procedure laid down in Article 54, paragraph 5 of this Article shall apply provided that the necessary appointments to the MDCG and expert panels have been made. 8. By way of derogation from Article 10a, point (a) of Article 10b(1) and Article 11(5) of Directive 90/385/EEC and Article 14(1) and (2), points (a) and (b) of Article 14a(1) and Article 16(5) of Directive 93/42/EEC, manufacturers, authorised representatives, importers and notified bodies which, during the period starting on the later of the dates referred to in point (d) of Article 123(3) and ending 18 months later, comply with Articles 29(4), 31(1) and 56(5) of this Regulation shall be considered to comply with the laws and regulations adopted by Member States in accordance with, respectively, Article 10a of Directive 90/385/EEC or Article 14(1) and (2) of Directive 93/42/EEC, with, respectively, point (a) of Article 10b(1) of Directive 90/385/EEC or points (a) and (b) of Article 14a(1) of Directive 93/42/EEC and with, respectively, Article 11(5) of Directive 90/385/EEC or Article 16(5) of Directive 93/42/EEC, as specified in Decision 2010/227/EU. 9. Authorisations granted by the competent authorities of the Member States in accordance with Article 9(9) of Directive 90/385/EEC or Article 11(13) of Directive 93/42/EEC shall keep the validity indicated in the authorisation. 10. Devices falling within the scope of this Regulation in accordance with point (g) of Article 1(6) which have been legally placed on the market or put into service in accordance with the rules in force in the Member States prior to 26 May 2020 2021 may continue to be placed on the market and put into service in the Member States concerned. 11. Clinical investigations which have started to be conducted in accordance with Article 10 of Directive 90/385/EEC or Article 15 of Directive 93/42/EEC prior to 26 May 2020 2021 may continue to be conducted. As of 26 May 2020, 2021, however, the 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.

02017R0745-20170505 → 02017R0745-20200424

Article 122 Repeal Without prejudice to Articles 120(3) 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 2020, 2021, with the exception of: Articles 8 and 10, points (b) and (c) of Article 10b(1), Article 10b(2) and Article 10b(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, points (c) and (d) of Article 14a(1), Article 14a(2), Article 14a(3) and Article 15 of Directive 93/42/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; and Article 14(1) and (2), points (a) and (b) of Article 14a(1) 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, 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. 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) and (4) of this Regulation, the Directives referred to in the first paragraph shall continue to apply until 27 May 2025 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.

02017R0745-20170505 → 02017R0745-20200424

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 2020. 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 2020, 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 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 2020, 2021, the obligations and requirements that relate to Eudamed shall apply from the date corresponding to six months after the date of publication of the notice referred to in Article 34(3). 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), Articles 70 to 77, paragraphs 1 to 13 of Article 78, 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), the second sentence of the first subparagraph of Article 120(3). Until Eudamed is fully functional, 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 vigilance reporting, clinical investigations, registration of devices and economic operators, and certificate notifications. (e) Article 29(4) and Article 56(5) shall apply from 18 months after the later of the dates referred to in point (d); (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) for with regard to reusable devices that shall 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 two years after the date referred to in point (f) of this paragraph for the respective 26 May 2023; (ii) class of IIa and class IIb devices in that point; 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. 2019; (j) Article 59 shall apply from 24 April 2020.

02017R0745-20170505 → 02017R0745-20200424

ANNEX IX CONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ON ASSESSMENT OF TECHNICAL DOCUMENTATION CHAPTER I QUALITY MANAGEMENT SYSTEM 1. The manufacturer shall establish, document and implement a quality management system as described in Article 10(9) and maintain its effectiveness throughout the … 3,623 unchanged words … justification provided by the notified body publicly available via Eudamed. (h) The Commission, after consultation with the Member States and relevant scientific experts shall provide guidance for expert panels for consistent interpretation of the criteria in point (c) before 26 May 2020. 2021. 5.2. Procedure in the case of devices incorporating a medicinal substance (a) Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of point 2 of … 1,770 unchanged words … kept at the disposal of competent authorities for the period indicated in that Section in case a manufacturer, or its authorised representative, established within its territory goes bankrupt or ceases its business activity prior to the end of that period.