Article 14 General obligations of distributors
1. When making a device available on the market, distributors shall, in the context of their activities, act with due care in relation to the requirements applicable.
2. Before making a device available on the market, distributors shall verify that all of the following requirements are met:
(a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
(b) the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10(11);
(c) for imported devices, the importer has complied with the requirements set out in Article 13(3);
(d) that, where applicable, a UDI has been assigned by the manufac turer.
In order to meet the requirements referred to in points (a), (b) and (d) of the first subparagraph the distributor may apply a sampling method that is representative of the devices supplied by that distributor.
Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not make the device available on the market until it has been brought into conformity, and shall inform the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer. Where the distributor considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which it is established.
3. Distributors shall ensure that, while the device is under their responsibility, storage or transport conditions comply with the conditions set by the manufacturer.
4. Distributors that consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, the manufacturer's authorised representative and the importer. Distributors shall co-operate with the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer, and with competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or to recall it, as appropriate, is taken. Where the distributor considers or has reason to believe that the device presents a serious risk, it shall also immediately inform the competent authorities of the Member States in which it made the device available, giving details, in particular, of the non-compliance and of any corrective action taken.
5. Distributors that have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device they have made available, shall immediately forward this information to the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer. They shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and keep the manufacturer and, where available, the authorised representative and the importer informed of such monitoring and provide them with any information upon their request.
6. Distributors shall, upon request by a competent authority, provide it with all the information and documentation that is at their disposal and is necessary to demonstrate the conformity of a device.
Distributors shall be considered to have fulfilled the obligation referred to in the first subparagraph when the manufacturer or, where applicable, the authorised representative for the device in question provides the required information. Distributors shall cooperate with competent authorities, at their request, on any action taken to eliminate the risks posed by devices which they have made available on the market. Distributors, upon request by a competent authority, shall provide free samples of the device or, where that is impracticable, grant access to the device.
Article 15 Person responsible for regulatory compliance
1. Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. The requisite expertise shall be demonstrated by either of the following qualifications:
Without prejudice to national provisions regarding professional qualifi cations, manufacturers of custom-made devices may demonstrate the requisite expertise referred to in the first subparagraph by having at least two years of professional experience within a relevant field of manufacturing.
2. Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC (1) shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal.
3. The person responsible for regulatory compliance shall at least be responsible for ensuring that:
(a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
(c) the post-market surveillance obligations are complied with in accordance with Article 10(10);
(d) the reporting obligations referred to in Articles 87 to 91 are fulfilled;
(e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
4. If a number of persons are jointly responsible for regulatory compliance in accordance with paragraphs 1, 2 and 3, their respective areas of responsibility shall be stipulated in writing.
5. The person responsible for regulatory compliance shall suffer no disadvantage within the manufacturer's organisation in relation to the proper fulfilment of his or her duties, regardless of whether or not they are employees of the organisation.
6. Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regu latory compliance who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union. The requisite expertise shall be demonstrated by either of the following qualifications:
(1) Commission Recommendation 2003/361/ΕC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).
(a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regu latory affairs or in quality management systems relating to medical devices;
(b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Article 16 Cases in which obligations of manufacturers apply to importers, distributors or other persons
1. A distributor, importer or other natural or legal person shall assume the obligations incumbent on manufacturers if it does any of the following:
(a) makes available on the market a device under its name, registered trade name or registered trade mark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation;
(b) changes the intended purpose of a device already placed on the market or put into service;
(c) modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected.
The first subparagraph shall not apply to any person who, while not considered a manufacturer as defined in point (30) of Article 2, assembles or adapts for an individual patient a device already on the market without changing its intended purpose.
2. For the purposes of point (c) of paragraph 1, the following shall not be considered to be a modification of a device that could affect its compliance with the applicable requirements:
(a) provision, including translation, of the information supplied by the manufacturer, in accordance with Section 23 of Annex I, relating to a device already placed on the market and of further information which is necessary in order to market the device in the relevant Member State;
(b) changes to the outer packaging of a device already placed on the market, including a change of pack size, if the repackaging is necessary in order to market the device in the relevant Member State and if it is carried out in such conditions that the original condition of the device cannot be affected by it. In the case of devices placed on the market in sterile condition, it shall be presumed that the original condition of the device is adversely affected if the packaging that is necessary for maintaining the sterile condition is opened, damaged or otherwise negatively affected by the repackaging.
3. A distributor or importer that carries out any of the activities mentioned in points (a) and (b) of paragraph 2 shall indicate on the device or, where that is impracticable, on its packaging or in a document accompanying the device, the activity carried out together with its name, registered trade name or registered trade mark, registered place of business and the address at which it can be contacted, so that its location can be established.
Distributors and importers shall ensure that they have in place a quality management system that includes procedures which ensure that the translation of information is accurate and up-to-date, and that the activities mentioned in points (a) and (b) of paragraph 2 are performed by a means and under conditions that preserve the original condition of the device and that the packaging of the repackaged device is not defective, of poor quality or untidy. The quality management system shall cover, inter alia, procedures ensuring that the distributor or importer is informed of any corrective action taken by the manu facturer in relation to the device in question in order to respond to safety issues or to bring it into conformity with this Regulation.
4. At least 28 days prior to making the relabelled or repackaged device available on the market, distributors or importers carrying out any of the activities mentioned in points (a) and (b) of paragraph 2 shall inform the manufacturer and the competent authority of the Member State in which they plan to make the device available of the intention to make the relabelled or repackaged device available and, upon request, shall provide the manufacturer and the competent authority with a sample or mock-up of the relabelled or repackaged device, including any translated label and instructions for use. Within the same period of 28 days, the distributor or importer shall submit to the competent authority a certificate, issued by a notified body designated for the type of devices that are subject to activities mentioned in points (a) and (b) of paragraph 2, attesting that the quality management system of the distributer or importer complies with the requirements laid down in paragraph 3.
1,在市场上出售设备时,分销商应在其活动范围内根据适用要求谨慎行事。
2.在将设备投放市场之前,分销商应验证是否满足以下所有要求:
(a)该设备已经过CE标记,并且已经起草了该设备的欧盟合格声明;
(b)该设备随附制造商根据第10(11)条提供的信息;
(c)对于进口设备,进口商已遵守第13条第3款的要求;
(d)制造商已在适当情况下分配了UDI。
为了满足第一小节(a),(b)和(d)中提到的要求,分配器可以采用代表该分配器提供的设备的采样方法。
分销商认为或有理由认为该设备不符合本法规的要求时,除非该设备符合要求,否则不得在市场上出售该设备,并应通知制造商并在适用的情况下,制造商的授权代表和进口商。分销商认为或有理由认为该设备存在严重风险或是伪造的设备时,还应通知其所成立成员国的主管当局。
3.分销商应确保在设备负责的情况下,存储或运输条件符合制造商规定的条件。
4,分销商认为或有理由相信其在市场上出售的设备不符合本法规的规定,应立即通知制造商,并在适用时通知制造商的授权代表和进口商。发行商应与制造商以及(如适用)制造商的授权代表,进口商和进口商以及主管当局合作,以确保采取必要的纠正措施以使该设备符合要求,酌情撤回或召回该设备,被采取。分销商认为或有理由认为该设备存在严重风险时,还应立即通知提供该设备的成员国主管当局,尤其要详细说明违规情况和存在的问题。采取的任何纠正措施。
5,已收到医疗保健专业人员,患者或用户对与他们提供的设备有关的可疑事件的投诉或报告的分销商,应立即将此信息转发给制造商以及制造商的授权代表和进口商(如果适用)。他们应保存投诉,不合格设备以及召回和撤回的记录,并应向制造商以及授权代理人和进口商(如果有的话)通知此类监视,并应其要求提供任何信息。
6,经主管当局要求,发行人应向其提供所有可用的信息和文件,以证明设备的合格性。
当制造商或有关设备的授权代表(如适用)提供所需信息时,经销商应被视为已履行第一小节中提到的义务。分销商应应其要求与主管当局合作,采取任何措施消除其在市场上出售的设备所带来的风险。分销商应主管当局的要求,应免费提供该设备的样品,或在不可行的情况下准许使用该设备。
1.制造商应在其组织内至少有一名负责法规遵从的人员,这些人员具有医疗设备领域的必要专业知识。必要的专业知识应通过以下任一资格证明:
(a)在法律,医学,药学,工程学或其他相关科学学科获得大学学位或相关成员国认可的同等学历的文凭,证书或其他正式资格证明, 至少一年的法规事务或与医疗设备有关的质量管理体系的专业经验;
(b)在与医疗器械有关的法规事务或质量管理体系方面有四年的专业经验。
在不影响有关专业资格的国家规定的情况下,定制设备的制造商可以通过在相关制造领域具有至少两年的专业经验来证明第一小节中提到的必要专业知识。
2.不应要求委员会建议2003/361 / EC(1)所指的小型和小型企业在其组织内具有负责合规性的人员,而应由该人员永久,连续地任职。
3.负责合规的人员至少应负责确保:
(a)在发布设备之前,根据制造设备的质量管理体系对设备的合格性进行适当检查;
(b)制定并保持了技术文件和欧盟符合性声明;
(c)遵守第10条第10款的规定的售后监督义务;
(d)履行了第87至91条所述的报告义务;
(e)就侦查设备而言,应发布附件XV第二章第4.1节所指的声明。
4,如果有许多人根据第1、2和3款共同负责遵守法规,则应书面规定各自的职责范围。
5,负责监管合规的人员在制造商组织内不会因适当履行其职责而受到不利影响,无论他们是否是该组织的雇员。
6,授权代表应永久,连续地拥有至少一位负责法规遵从的人员,这些人员具有有关国际联盟医疗器械法规要求的必要专业知识。必要的专业知识应通过以下任一资格证明:
(I)委员会2003年5月6日关于微型,中小型企业定义的第2003/361 / EC号建议书(OJ L 124,20.5.2003,第36页)。
(a)在法律,医学,药学,工程学或其他相关科学学科获得大学学位或相关成员国认可的同等学历的文凭,证书或其他正式资格证明, 至少一年的法规事务或与医疗设备有关的质量管理体系的专业经验;
(c)在与医疗器械有关的法规事务或质量管理体系方面有四年的专业经验。
1,分销商,进口商或其他自然人或法人有下列任何行为,应承担制造商应承担的义务:
(a)在市场上以其名称,注册商标名称或注册商标提供设备,除非分销商或进口商与制造商达成协议,从而在标签上标识出该制造商并负责满足本法规对制造商的要求;
(b)更改已经投放市场或投入使用的设备的预期用途;
(c)修改已经投放市场或投入使用的设备,以免影响对适用要求的遵守。
第一小节不适用于未视第2条第(30)款定义的制造商而为单个患者组装或改装已投放市场的设备而未改变其预期用途的任何人。
2.出于第1款(c)点的目的,以下内容不应被视为对设备的修改,可能会影响其对适用要求的遵守:
(a)提供(包括翻译)制造商根据附件I第23节提供的与已投放市场的设备有关的信息,以及为在相关市场中销售该设备所必需的进一步信息会员国;
(b)如果有必要重新包装以便在有关成员国市场上销售该设备,并且已经在某种情况下进行了包装,则必须更改已经投放市场的设备的外包装,包括改变包装尺寸不会影响设备的原始状态。对于以无菌状态投放市场的器械,如果保持无菌状态所需的包装被打开,损坏或以其他方式受到不利影响,则应假定器械的原始状态受到不利影响。
3.进行第2款(a)和(b)项提及的任何活动的分销商或进口商,应在设备上或在不可行的情况下在其包装或设备随附的文件中注明活动及其名称,注册商标名称或注册商标,注册营业地点以及可联系该地址的地址,以便确定其位置。
分销商和进口商应确保他们建立了质量管理体系,该体系包括确保信息翻译准确和最新的程序,以及第2款(a)和(b)所述的活动。在保持设备原始状态并且重新包装的设备的包装没有缺陷,质量差或不整洁的情况下,以一定的方式和条件进行操作。质量管理体系应特别包括确保向制造商或进口商告知制造商针对所涉及设备采取的任何纠正措施的措施,以响应安全问题或使其符合此要求。规。
4,进行重新贴标签或重新包装的设备在市场上发售的至少28天前,进行第2款(a)和(b)项提及的任何活动的分销商或进口商应将以下内容告知制造商和主管当局:他们打算在其中提供该设备的会员国打算提供该重新贴标签或重新包装的设备,并应要求向制造商和主管当局提供该重新贴标签或重新包装的设备的样品或模型,包括任何翻译后的标签和使用说明。在28天之内,分销商或进口商应向主管当局提交由指定机构指定的认证机构签发的证书,该认证机构应从事第2款(a)和(b)项所述活动的类型,证明分销商或进口商的质量管理体系符合第3款规定的要求。
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