Article 53 Involvement of notified bodies in conformity assessment procedures
1. Where the conformity assessment procedure requires the involvement of a notified body, the manufacturer may apply to a notified body of its choice, provided that the chosen notified body is designated for conformity assessment activities related to the types of devices concerned. The manufacturer may not lodge an application in parallel with another notified body for the same conformity assessment procedure.
2. The notified body concerned shall, by means of the electronic system referred to in Article 57, inform the other notified bodies of any manufacturer that withdraws its application prior to the notified body's decision regarding the conformity assessment.
3. When applying to a notified body under paragraph 1, manufac turers shall declare whether they have withdrawn an application with another notified body prior to the decision of that notified body and provide information about any previous application for the same conformity assessment that has been refused by another notified body.
4. The notified body may require any information or data from the manufacturer, which is necessary in order to properly conduct the chosen conformity assessment procedure.
5. Notified bodies and the personnel of notified bodies shall carry out their conformity assessment activities with the highest degree of profes sional integrity and the requisite technical and scientific competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups with an interest in the results of those activities.
Article 54 Clinical evaluation consultation procedure for certain class III and class IIb devices
1. In addition to the procedures applicable pursuant to Article 52, a notified body shall also follow the procedure regarding clinical evaluation consultation as specified in Section 5.1 of Annex IX or as referred to in Section 6 of Annex X, as applicable, when performing a conformity assessment of the following devices:
(a) class III implantable devices, and
(b) class IIb active devices intended to administer and/or remove a medicinal product, as referred to in Section 6.4 of Annex VIII (Rule 12).
2. 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 manu facturer for this device is in compliance with the relevant CS for clinical evaluation of that kind of device.
3. The notified body shall notify the competent authorities, the authority responsible for notified bodies and the Commission through the electronic system referred to in Article 57 of whether or not the procedure referred to in paragraph 1 of this Article is to be applied. That notification shall be accompanied by the clinical evaluation assessment report.
4. The Commission shall draw up an annual overview of devices which have been subject to the procedure specified in Section 5.1 of Annex IX and referred to in Section 6 of Annex X. The annual overview shall include the notifications in accordance with paragraph 3 of this Article and point (e) of Section 5.1 of Annex IX and a listing of the cases where the notified body did not follow the advice from the expert panel. The Commission shall submit this overview to the European Parliament, to the Council and to the MDCG.
5. The Commission shall by 27 May 2025 draw up a report on the operation of this Article and submit it to the European Parliament and to the Council. The report shall take into account the annual overviews and any available relevant recommendations from the MDCG. On the basis of that report the Commission shall, if appropriate, make proposals for amendments to this Regulation.
Article 55 Mechanism for scrutiny of conformity assessments of certain class III and class IIb devices
1. A notified body shall notify the competent authorities of certificates it has granted to devices for which the conformity assessment has been performed pursuant to Article 54(1). Such notifi cation shall take place through the electronic system referred to in Article 57 and shall include the summary of safety and clinical performance pursuant to Article 32, the assessment report by the notified body, the instructions for use referred to in Section 23.4 of Annex I, and, where applicable, the scientific opinion of the expert panels referred to in Section 5.1 of Annex IX or Section 6 of Annex X, as applicable. In the case of divergent views between the notified body and the expert panels, a full justification shall also be included.
2. A competent authority and, where applicable, the Commission may, based on reasonable concerns apply further procedures in accordance with Article 44, 45, 46, 47 or 94 and, where deemed necessary, take appropriate measures in accordance with Articles 95 and 97.
3. The MDCG and, where applicable, the Commission, may, based on reasonable concerns, request scientific advice from the expert panels in relation to the safety and performance of any device.
1,如果合格评定程序需要公告机构的参与,制造商可以向其选择的公告机构申请,前提是指定选定的公告机构进行与有关设备类型有关的合格评定活动。对于相同的合格评定程序,制造商不得与其他公告机构并行提交申请。
2.有关公告机构应通过第57条所述的电子系统,在公告机构作出合格评定决定之前,通知撤回其申请的任何制造商的其他公告机构。
3.根据第1款向公告机构提出申请时,制造商应在该公告机构作出决定之前声明他们是否已向另一公告机构撤回申请,并提供有关先前任何被拒绝进行同一合格评定的信息由另一个公告机构。
4.公告机构可能要求制造商提供任何信息或数据,以正确执行所选的合格评定程序。
5,认证机构和认证机构的人员应在特定领域中以最高的专业操守和必要的技术和科学能力进行合格评定活动,并且应避免一切压力和诱因,尤其是财务上的压力可能会影响他们的判断或他们的合格评定活动的结果,尤其是对于那些对这些活动的结果感兴趣的个人或团体。
1,除执行第52条所适用的程序外,公告机构在执行以下程序时还应遵循附件IX第5.1节中规定或附件X第6节中有关临床评估咨询的程序。以下设备的合格评定:
(a)III类可植入装置,及
(b)附件VIII(细则12)第6.4节所指的旨在管理和/或移除药品的IIb类有源设备。
2,此处提到的设备不需要第1款中提到的程序:
(a)如属根据本规例发出的证明书的续期;
(b)如果该设备是通过修改同一制造商已经为同一预期目的销售的设备而设计的,但制造商必须证明公告机构满意,并且该修改不会对利益风险比产生不利影响设备的;要么
(c)在第9条所述的CS中已对器械类型或类别进行临床评估的原则,并且认证机构确认对器械制造商的临床评估符合相关的CS用于此类设备的临床评估。
3.公告机构应通过第57条所述的电子系统通知主管机关,负责公告机构的主管部门和委员会是否应采用本条第1款所述的程序。该通知应附有临床评估报告。
4,委员会应按附件IX第5.1节规定并按附件X第6节规定的程序起草设备的年度概览。年度概览应包括根据本条第3款发出的通知附件九第5.1条第(e)项和要点,以及公告机构未遵循专家小组建议的情况的清单。委员会应将此概述提交给欧洲议会,理事会和MDCG。
5,委员会应在2025年5月27日之前起草关于本条执行情况的报告,并提交给欧洲议会和理事会。该报告应考虑年度概览以及MDCG提出的任何相关建议。委员会应在该报告的基础上酌情提出修改本条例的建议。
1,公告机构应将已授予根据第54条第1款对其进行合格评定的设备的证书通知主管当局。此类通知应通过第57条提及的电子系统进行,并且应包括根据第32条提出的安全性和临床表现摘要,公告机构的评估报告,附件I第23.4节中提及的使用说明,以及(如适用)附件IX第5.1节或附件X第6节所指专家小组的科学意见。如果公告机构与专家小组之间存在分歧,则也应包括充分的理由。
2主管当局和委员会(如适用)可在合理关注的基础上根据第44、45、46、47或94条适用进一步的程序,并在认为必要时根据第95条和第97条采取适当措施。
3. MDCG和委员会(如果适用)可以基于合理的考虑,要求专家小组就任何设备的安全性和性能提出科学建议。
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