Article 46 Changes to designations and notifications
1. The authority responsible for notified bodies shall notify the Commission and the other Member States of any relevant changes to the designation of a notified body.
The procedures described in Article 39 and in Article 42 shall apply to extensions of the scope of the designation.
For changes to the designation other than extensions of its scope, the procedures laid down in the following paragraphs shall apply.
2. The Commission shall immediately publish the amended notifi cation in NANDO. The Commission shall immediately enter information on the changes to the designation of the notified body in the electronic system referred to in Article 57.
3. Where a notified body decides to cease its conformity assessment activities it shall inform the authority responsible for notified bodies and the manufacturers concerned as soon as possible and in the case of a planned cessation one year before ceasing its activities. The certificates may remain valid for a temporary period of nine months after cessation of the notified body's activities on condition that another notified body has confirmed in writing that it will assume responsibilities for the devices covered by those certificates. The new notified body shall complete a full assessment of the devices affected by the end of that period before issuing new certificates for those devices. Where the notified body has ceased its activity, the authority responsible for notified bodies shall withdraw the designation.
4. Where a authority responsible for notified bodies has ascertained that a notified body no longer meets the requirements set out in Annex VII, or that it is failing to fulfil its obligations or has not im plemented the necessary corrective measures, the authority shall suspend, restrict, or fully or partially withdraw the designation, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. A suspension shall not exceed a period of one year, renewable once for the same period.
The authority responsible for notified bodies shall immediately inform the Commission and the other Member States of any suspension, restriction or withdrawal of a designation.
5. Where its designation has been suspended, restricted, or fully or partially withdrawn, the notified body shall inform the manufacturers concerned at the latest within 10 days.
6. In the event of restriction, suspension or withdrawal of a desig nation, the authority responsible for notified bodies shall take appro priate steps to ensure that the files of the notified body concerned are kept and make them available to authorities in other Member States responsible for notified bodies and to authorities responsible for market surveillance at their request.
7. In the event of restriction, suspension or withdrawal of a desig nation, the authority responsible for notified bodies shall:
(a) assess the impact on the certificates issued by the notified body;
(b) submit a report on its findings to the Commission and the other Member States within three months of having notified the changes to the designation;
(c) require the notified body to suspend or withdraw, within a reasonable period of time determined by the authority, any certificates which were unduly issued to ensure the safety of devices on the market;
(d) enter into the electronic system referred to in Article 57 information in relation to certificates of which it has required their suspension or withdrawal;
(e) inform the competent authority for medical devices of the Member State in which the manufacturer has its registered place of business through the electronic system referred to in Article 57 of the certificates for which it has required suspension or withdrawal. That competent authority shall take the appropriate measures, where necessary to avoid a potential risk to the health or safety of patients, users or others.
8. With the exception of certificates unduly issued, and where a designation has been suspended or restricted, the certificates shall remain valid in the following circumstances:
(a) the authority responsible for notified bodies has confirmed, within one month of the suspension or restriction, that there is no safety issue in relation to certificates affected by the suspension or restriction, and the authority responsible for notified bodies has outlined a timeline and actions anticipated to remedy the suspension or restriction; or
(b) the authority responsible for notified bodies has confirmed that no certificates relevant to the suspension will be issued, amended or re- issued during the course of the suspension or restriction, and states whether the notified body has the capability of continuing to monitor and remain responsible for existing certificates issued for the period of the suspension or restriction. In the event that the authority responsible for notified bodies determines that the notified body does not have the capability to support existing certificates issued, the manufacturer shall provide, to the competent authority for medical devices of the Member State in which the manufacturer of the device covered by the certificate has its registered place of business, within three months of the suspension or restriction, a written confirmation that another qualified notified body is temporarily assuming the functions of the notified body to monitor and remain responsible for the certificates during the period of suspension or restriction.
9. With the exception of certificates unduly issued, and where a designation has been withdrawn, the certificates shall remain valid for a period of nine months in the following circumstances:
(a) where the competent authority for medical devices of the Member State in which the manufacturer of the device covered by the certificate has its registered place of business has confirmed that there is no safety issue associated with the devices in question; and
(b) another notified body has confirmed in writing that it will assume immediate responsibilities for those devices and will have completed assessment of them within twelve months of the with drawal of the designation.
In the circumstances referred to in the first subparagraph, the competent authority for medical devices of the Member State in which the manu facturer of the device covered by the certificate has its place of business may extend the provisional validity of the certificates for further periods of three months, which altogether shall not exceed twelve months.
The authority or the notified body assuming the functions of the notified body affected by the change of designation shall immediately inform the Commission, the other Member States and the other notified bodies thereof.
Article 47 Challenge to the competence of notified bodies
1. The Commission, in conjunction with the MDCG, shall investigate all cases where concerns have been brought to its attention regarding the continued fulfilment by a notified body, or of one or more of its subsidiaries or subcontractors, of the requirements set out in Annex VII or the obligations to which they are subject. It shall ensure that the relevant authority responsible for notified bodies is informed and is given an opportunity to investigate those concerns.
2. The notifying Member State shall provide the Commission, on request, with all information regarding the designation of the notified body concerned.
3. The Commission, in conjunction with the MDCG, may initiate, as applicable, the assessment procedure described in Article 39(3) and (4), where there is reasonable concern about the ongoing compliance of a notified body or a subsidiary or subcontractor of the notified body with the requirements set out in Annex VII and where the investigation by the authority responsible for notified bodies is not deemed to have fully addressed the concerns or upon request of the authority responsible for notified bodies. The reporting and outcome of that assessment shall follow the principles of Article 39. Alternatively, depending on the severity of the issue, the Commission, in conjunction with the MDCG, may request that the authority responsible for notified bodies allow the participation of up to two experts from the list established pursuant to Article 40 in an on-site assessment as part of the planned monitoring and assessment activities in accordance with Article 44 and as outlined in the annual assessment plan described in Article 44(4).
4. Where the Commission ascertains that a notified body no longer meets the requirements for its designation, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including the suspension, restriction or withdrawal of the designation if necessary.
Where the Member State fails to take the necessary corrective measures, the Commission may, by means of implementing acts, suspend, restrict or withdraw the designation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3). It shall notify the Member State concerned of its decision and update NANDO and the electronic system referred to in Article 57.
5. The Commission shall ensure that all confidential information obtained in the course of its investigations is treated accordingly.
Article 48 Peer review and exchange of experience between authorities responsible for notified bodies
1. The Commission shall provide for the organisation of exchange of experience and coordination of administrative practice between the auth orities responsible for notified bodies. Such exchange shall cover elements including:
(a) development of best practice documents relating to the activities of the authorities responsible for notified bodies;
(b) development of guidance documents for notified bodies in relation to the implementation of this Regulation;
(c) training and qualification of the experts referred to in Article 40;
(d) monitoring of trends relating to changes to notified body desig nations and notifications and trends in certificate withdrawals and transfers between notified bodies;
(e) monitoring of the application and applicability of scope codes referred to in Article 42(13);
(f) development of a mechanism for peer reviews between authorities and the Commission;
(g) methods of communication to the public on the monitoring and surveillance activities of authorities and the Commission on notified bodies.
2. The authorities responsible for notified bodies shall participate in a peer review every third year through the mechanism developed pursuant to paragraph 1 of this Article. Such reviews shall normally be conducted in parallel with the on-site joint assessments described in Article 39. Alternatively, an authority may make the choice of having such reviews take place as part of its monitoring activities referred to in Article 44.
3. The Commission shall participate in the organisation and provide support to the implementation of the peer review mechanism.
4. The Commission shall compile an annual summary report of the peer review activities, which shall be made publicly available.
5. The Commission may, by means of implementing acts, adopt measures setting out the detailed arrangements and related documents for the peer review mechanism and training and qualification as referred to in paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
Article 49 Coordination of notified bodies
The Commission shall ensure that appropriate coordination and cooper ation between notified bodies is put in place and operated in the form of a coordination group of notified bodies in the field of medical devices, including in vitro diagnostic medical devices. This group shall meet on a regular basis and at least annually.
The bodies notified under this Regulation shall participate in the work of that group.
The Commission may establish the specific arrangements for the func tioning of the coordination group of notified bodies.
Article 50 List of standard fees
Notified bodies shall establish lists of their standard fees for the conformity assessment activities that they carry out and shall make those lists publicly available.
1,负责指定机构的主管机关应将指定机构的指定变更通知委员会和其他成员国。
第39条和第42所述的程序应适用于指定范围的扩展。
除扩展范围外,对名称的更改应适用以下各款规定的程序。
2.委员会应立即在NANDO中发布修订后的通知。委员会应立即输入有关第57条所指电子系统中指定机构名称变更的信息。
3.认证机构决定终止其合格评定活动时,应尽快通知负责认证机构的主管部门和有关制造商,如果计划中止,则应在停止其活动前一年通知。如果另一认证机构书面确认它将对这些证书所涵盖的设备承担责任,则该证书在指定机构的活动停止后的九个月内可以保持有效。新的认证机构应在对那些设备签发新证书之前,对该期间结束前的设备进行全面评估。指定机构停止活动的,负责指定机构的主管机关应撤销指定。
4,负责指定机构的主管当局确定指定机构不再符合附件VII的要求,或者该机构未履行其义务或未采取必要的纠正措施时,该机构应中止执行,根据不满足这些要求或履行这些义务的严重性,限制或完全或部分撤销该指定。停权期限不得超过一年,同一时期可以延期一次。
负责指定机构的机构应立即将指定的任何中止,限制或撤销通知欧洲委员会和其他成员国。
5,如果其名称被暂停,限制或全部或部分撤销,指定机构应最迟在10天内通知有关制造商。
6,在设计国受到限制,中止或撤回的情况下,负责指定机构的主管机关应采取适当步骤,以确保保存有关指定机构的档案并将其提供给其他负责任成员国的主管机关应指定机构和负责市场监督的机构的要求。
7,如果设计国受到限制,中止或撤回,负责指定机构的主管机关应:
(a)评估对指定机构签发的证书的影响;
(b)在通知指定变更后的三个月内,将其调查结果提交给委员会和其他成员国;
(c)要求指定机构在当局确定的合理时间内中止或撤消为确保市场上的设备安全而不适当地签发的任何证书;
(d)进入第57条所指的电子系统中,有关其要求吊销或撤回证书的信息;
(e)通过要求中止或撤销证书的第57条所述的电子系统,通知制造商在其注册营业地的成员国的医疗器械主管当局。该主管当局应在必要时采取适当措施,以避免对患者,使用者或他人的健康或安全造成潜在风险。
8,除不当签发的证书外,并暂停或者限制名称的,证书在下列情况下仍然有效:
(a)公告机构的负责人已在暂停或限制的一个月内确认与受暂停或限制的影响的证书没有安全问题,并且公告机构的负责人已概述了时间表和预期采取的补救措施,以中止或限制;要么
(b)负责公告机构的主管当局已确认,在暂停或限制过程中将不会颁发,修改或重新颁发与该暂停有关的证书,并说明公告机构是否有能力继续监视和限制对在暂停或限制期间发行的现有证书负责。如果负责指定机构的主管部门确定指定机构不具备支持现有已颁发证书的能力,则制造商应向其医疗器械制造商所涵盖的成员国的医疗器械主管当局提供服务。证书在暂停或限制后的三个月内以其注册的营业地点发出书面确认,确认另一个合格的认证机构将暂时承担认证机构的职能,以在暂停或暂停期间对证书负责并对其负责限制。
9,除下列情况外,证书的签发不当以及撤消的,证书有效期为九个月:
(a)证书所涵盖的设备的制造商在其成员国内注册的营业所在成员国的医疗设备的主管当局已确认与所讨论的设备不存在安全问题;和
(b)另一个指定机构已书面确认将立即承担对这些设备的责任,并将在撤消指定后的十二个月内完成对它们的评估。
在第一小节所述的情况下,证书所涵盖的器械制造商在其营业地所在的成员国医疗器械主管当局可以将证书的临时有效期再延长三个期限月,总共不得超过十二个月。
承担指定变更影响的指定机构职能的当局或指定机构应立即将其通知委员会,其他成员国和其他指定机构。
1,委员会应与MDCG一起调查提请其注意的所有情况,这些关注涉及公告机构或其一个或多个子公司或分包商是否继续履行附件中规定的要求VII或它们应承担的义务。它应确保通知公告机构的有关主管部门,并有机会调查这些问题。
2.发出通知的成员国应应要求向委员会提供有关指定的公告机构的所有信息。
3 如果合理地关注公告机构或子公司或分包商的持续遵守情况,委员会可与MDCG一起酌情启动第39条第3款和第4款所述的评估程序认证机构必须遵守附录VII中的要求,并且在被认为不负责由认证机构主管部门进行的调查时,或在应负责认证机构主管部门的要求的情况下,不能充分解决其关注点。评估的报告和结果应遵循第39条的原则。或者,根据问题的严重性,委员会与MDCG一起可以要求负责公告机构的机构允许最多两个机构的参与。根据第40条和第44条第4款所述的年度评估计划中概述的,根据第40条建立的清单中的专家进行的现场评估,作为根据44条进行的计划的监视和评估活动的一部分。
4,如果委员会确定公告机构不再满足公告机构的要求,则应将其告知通知成员国并要求其采取必要的纠正措施,包括在必要时中止,限制或撤销指定。
如果会员国未采取必要的纠正措施,委员会可以通过实施法令中止,限制或撤销该指定。那些实施行为应按照第114条第3款规定的审查程序通过。它应将其决定通知有关成员国并更新NANDO和第57条所述的电子系统。
5.委员会应确保对在调查过程中获得的所有机密信息进行相应处理。
1.委员会应规定负责公告机构的主管部门之间的经验交流和行政实践的协调。这种交换应包括以下内容:
(a)制定与负责公告机构的当局的活动有关的最佳做法文件;
(b)为公告机构制定与实施本法规有关的指导文件;
(c)第40条所述专家的培训和资格认定;
(d)监测与公告机构名称变更有关的趋势以及指定机构之间证书撤回和转让的通知和趋势;
(e)监督第42条第13款所指的范围代码的适用性和适用性;
(f)建立主管部门与委员会之间同行审查的机制;
(g)向公众传达有关当局和委员会对指定机构的监督和监视活动的方法。
2,负责指定机构的主管机关应每三年根据本条第1款建立的机制参加同行评审。此类审查通常应与第39条所述的现场联合评估同时进行。或者,主管机关可以选择进行此类审查,作为其在第44条中提及的监测活动的一部分。
3.委员会应参与组织并为同行评审机制的实施提供支持。
4,委员会应编写同行评审活动的年度总结报告,并向公众公开。
5,委员会可以采取行动,采取措施规定本条第一款所指的同行评审机制以及培训和资格的详细安排和有关文件。那些实施行为应按照第114条第3款规定的审查程序通过。
委员会应确保在医疗器械(包括体外诊断医疗器械)领域中,公告机构之间建立适当的协调与合作,并以公告机构协调小组的形式开展工作。该小组应定期开会,至少每年一次。
根据本法规通知的机构应参加该小组的工作。
委员会可为公告机构的协调小组的职能制定具体安排。
公告机构应建立其进行的合格评定活动的标准费用清单,并应将这些清单公开。
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