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This document deals with registration of devices, which can continue to be placed on the market under Directive certificates by virtue of Article 120(3) of Regulation 745/2017 (MDR), and Article 110(3) of Regulation 746/2017 (IVDR) after the relevant MDRs application dates. Those products are, for the purpose of this document, referred to as “legacy devices”1. All following considerations, which are made in relation to the MDR shall apply to the IVDR, mutatis mutandis. Art 120(3) of the MDR lays down that the requirements of the MDR relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply to legacy devices placed on the market after the application date of the MDR in place of the corresponding requirements of the Directives. The MDR is not explicit in requiring that these “legacy devices” are subject to relevant UDI obligations. The MDR device registration requirements (Annex VI Part A Section 2 and Part B that are complementary) make the Basic UDI-DI and UDI-DI the access keys for device-related information in the future Eudamed, which is reflected in the database design. Therefore, any registration of a device is normally possible in Eudamed only if a proper Basic UDI-DI and UDI-DI are assigned to the device and registered in the database together with the other device-related data.

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“With regard to timelines for device registration, the text of the MDR presents an inconsistency. On the one hand, Article 123(3)(d) lists the full Article 29 as being applicable from the application dates or, if EUDAMED is not functional on time, six months after the date of publication of the notice referred to in Article 34(3). On the other hand, Article 123(3)(e) grants an additional 18-month transitional period for obligations contained in Article 29(4). Taking into account: - the declared will of the co-legislator to grant an 18-month additional transitional period for device registration and registration of certificates, - the logical correspondence and complementary character of device data elements in Part A (Section 2) and Part B of Annex VI, - the need to ensure that information on devices in EUDAMED is not displayed to public in a partial or misleading nature, the obligation for registration in EUDAMED of device data elements listed in both part A, Section 2, and Part B of Annex VI, shall be applicable as from the timelines indicated in Article 123(3)(e) (meaning from 18 months after the general application date or, if EUDAMED is not fully functional on time, from 24 months after the date of publication of the notice referred to in Article 34(3)). [생략]

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Interpretation of Article 54(2)b Article 54(2) of the MDR lays down three criteria that exempt devices from the pre-market clinical evaluation consultation procedure with the involvement of expert panels. In particular that article states that: “The procedure referred to in paragraph 1 shall not be required for the devices referred to therein: (a) in the case of renewal of a certificate issued under this Regulation; (b) where the device has been designed by modifying a device already marketed by the same manufacturer for the same intended purpose, provided that the manufacturer has demonstrated to the satisfaction of the notified body that the modifications do not adversely affect the benefit-risk ratio of the device; or (c) where the principles of the clinical evaluation of the device type or category have been addressed in a CS referred to in Article 9 and the notified body confirms that the clinical evaluation of the manufacturer for this device is in compliance with the relevant CS for clinical evaluation of that kind of device”. Interpretation of point (b) of Article 54(2) is unclear, notably in relation to the application of the word “marketed”. In fact, while in point “a” the co-legislator explicitly indicates that the certificates referred to are those issued under the new Regulation, in point “b” there is no indication of whether a “device already marketed” refers to devices already marketed under the Directives or the Regulations. This has raised questions from the public and from Member States. As we are about to launch the procedures for the establishment of expert panels, clarification of this issue is extremely urgent, notably due to its impact on the future workload of panels and hence on relevant budget and workload estimations. The following considerations seem to indicate that the expression “device already marketed” cannot be intended to refer to a device already marketed uniquely under the new Regulation:  If the co-legislators had decided to restrict the application of point “b” to devices marketed uniquely under the MDR, they would have explicitly stated so, as they did for point “a”;  Article 54, together with other Articles (such as Article 61(6) and Article 120(3)), was written at the end of the negotiation process with a view to smoothen the implementation of the new Regulation. Therefore the interpretation of the exemption should be understood in line with the spirit and intention of the co-legislators. It has to be noted that, in respect to devices that have been marketed already under the relevant Directives, the word “modification” shall be meant as limited only to those modifications needed in order to comply with the new legal requirements introduced by the MDR.

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1. Scope Article 1(8),1(9), 1(10) of the Medical Device Regulation (EU) 2017/745 (MDR) set the basic criteria to determine whether and to what extent the relevant legislation on medical devices, medicinal products, human tissue and cells apply to certain products containing a medical device part. In particular, “8. Any device which, when placed on the market or put into service, incorporates, as an integral part, a substance which, if used separately, would be considered to be a medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma as defined in point 10 of Article 1 of that Directive, and that has an action ancillary to that of the device, shall be assessed and authorised in accordance with this Regulation. However, if the action of that substance is principal and not ancillary to that of the device, the integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004 of the European Parliament and of the Council, as applicable. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part are concerned. 9. Any device which is intended to administer a medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC shall be governed by this Regulation, without prejudice to the provisions of that Directive and of Regulation (EC) No 726/2004 with regard to the medicinal product. However, if the device intended to administer a medicinal product and the medicinal product are placed on the market in such a way that they form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part of the single integral product are concerned.” 10. Any device which, when placed on the market or put into service, incorporates, as an integral part, non-viable tissues or cells of human origin or their derivatives that have an action ancillary to that of the device shall be assessed and authorised in accordance with this Regulation. In that case, the provisions for donation, procurement and testing laid down in Directive 2004/23/EC shall apply. However, if the action of those tissues or cells or their derivatives is principal and not ancillary to that of the device and the product is not governed by Regulation (EC) No 1394/2007, the product shall be governed by Directive 2004/23/EC. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part are concerned”.

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In order to ensure, to the maximum possible extent, the quality of the code value entered in Eudamed, the Basic UDI-DI requirements on format should be as close as possible to the ones for the UDI-DI. In particular,  the Basic UDI-DI code value shall have maximum 25 characters, so that it does not differ too significantly from the maximum length of the UDI-DI as established by the issuing entities;  a check digit/character must be part of the Basic UDI-DI, based on an algorithm defined by the issuing entity. This algorithm shall be provided by the issuing entities to the Commission and to the manufacturers.