荷兰医疗器材登记法规问题集
Email：ams4ww@evershinecpa.com
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荷兰永辉BPO有限公司
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Anna Wang, 说荷兰文中文和英文
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skype: annylin8008
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HLF-NL-10
请问荷兰对于医疗器材的归类方式为何？它的正式名称为何？
不同归类管理强度有何差异?它的政府管辖机构为何？网页？
What are the categories of medical devices in Kingdom of the Netherlands? What is its official name?
What is the intensity of management of different categories? What is the governmental authority of medical devices? Website?
Evershine RD：
在荷兰，健康和青年护理检查局(IGJ) 对医疗器材的安全性以及医疗保健提供者的安全使用进行监督，包含医疗技术的整个生命週期：
1.设计
2.市场介绍
3.选购
4.临床使用
5.上市后监督 (PMS)
6.管理
7.退出
医疗器材是用于医疗保健部门诊断和治疗的产品，或可以帮助预防或预测疾病/病症的产品。例如：
1.轮椅
2.乳房植入物
3.手术器材
4.起搏器
5.软件
体外诊断 (IVD) 是一种单独的医疗器材，用于检查身体材料的样本，例如：
1. 尿检
2. 妊娠试验
3. 血糖仪等
医疗器材根据风险进行分类，患者面临的风险越大，检查医疗器材是否会被允许进入市场的检查就越严格，由低至高分成4类：
1. I：低风险医疗器材，例如绷带。
2. IIa ：中度风险医疗器材，例如皮下注射针头。
3. IIb ：中高风险医疗器材，例如麻醉机。
4. III ：与心脏、中枢循环系统或中枢神经系统直接接触的医疗器材，例如心导管和避孕线圈。
In the Netherlands, the Health and Youth Care Inspectorate (IGJ) oversees the safety of medical devices and their safe use by healthcare providers, covering the entire life cycle of medical technology:
1. Design
2. Market introduction
3. Shopping
4. Clinical use
5. Post-market surveillance (PMS)
6. Management
7. Exit
A medical device is a product that is used for diagnosis and treatment in the healthcare sector or that can help prevent or predict disease/condition. E.g:
1. Wheelchair
2. Breast Implants
3. Surgical device
4. Pacemaker
5. Software
In vitro diagnostic (IVD) is a separate medical device used to examine samples of bodily materials such as:
1. Urine test
2. Pregnancy test
3. Blood glucose meter, etc.
Medical devices are classified according to risk. The greater the risk to the patient, the stricter the inspection to check whether the medical device will be allowed to enter the market. It is divided into 4 categories from the lowest to the highest:
1. I: Low risk medical devices, such as bandages.
2. IIa: Moderate risk medical devices, such as hypodermic needles.
3. IIb: Medium to high risk medical device, such as anesthesia machines.
4. III: Medical devices that come into direct contact with the heart, central circulatory system or central nervous system, such as cardiac catheters and contraceptive coils.
【参考连结】
https://business.gov.nl/regulation/medical-devices/
HLF-NL-20
外国公司要到荷兰销售医疗器材，无论设100%子公司或分公司，需要在公司登记时取得营业特许证？
假如要，其必要条件是什麽？所需文件及申请程序为何？网页？
If a foreign company wants to sell medical devices in Kingdom of the Netherlands, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration? If so, what are the requests? What are the required documents and application procedures? Website?
Evershine RD：
无须申请营业特许证。
No business license is required.
【参考连结】
https://business.gov.nl/regulation/medical-devices/
HLF-NL-25
假如需要办理，请问荷兰有专业服务公司可以协助办理医疗器材公司营业许可证？
Evershine RD：
无须申请营业特许证。
HLF-NL-30
外国公司要到荷兰销售医疗器材，可以指派荷兰公司担任营业代理人销售吗? 担任营业代理人，其必要条件是什麽？
所需文件及申请程序为何？外国公司与营业代理人的产品责任为何?网页？
If a foreign company wants to sell medical devices in Kingdom of the Netherlands, can it assign a Kingdom of the Netherlands company to act as a business agent? What are the requests for acting as a business agent? What are the required documents and application procedures? What is the product liability of foreign companies and the business agents? Website?
Evershine RD：
可以。在荷兰销售医疗器材，需要当地的製造商或授权当地代表完成註册，才得以投放到市场。
授权代表
1. 如果製造商不在成员国境内，则只有在製造商指定唯一授权代表的情况下，设备才能投放到欧盟市场。
2. 指定构成授权代表的授权，只有在授权代表书面接受时才有效，并且至少对同一通用器材组的所有器材有效。
3. 授权代表应执行其与製造商约定的任务规定的任务。授权代表应根据要求向主管当局提供授权书副本。
授权应要求且製造商应允许授权代表至少执行以下与其涵盖的设备有关的任务：
．验证是否已起草欧盟符合性声明和技术文件，并且在适用的情况下，製造商是否已执行适当的合格评定程序。
．保留技术文件副本、欧盟符合性声明以及相关证书（如适用）的副本，包括任何修改和补充，以供主管当局使用。
．遵守註册义务，并核实製造商已遵守註册义务。
．以相关成员国确定的欧盟官方语言向该主管当局提供证明器材符合性所需的所有信息和文件。
．将授权代表註册营业地所在成员国的主管当局的任何请求转发给製造商，以获取样品或访问设备，并验证主管当局是否收到样品或有权访问设备。
．与主管当局合作採取任何预防或纠正措施，以消除或在不可能的情况下减轻器材带来的风险。
．立即通知製造商有关医疗保健专业人员、患者和用户关于与他们指定使用的设备相关的可疑事件的投诉和报告。
．如果製造商的行为违反本法规下的义务，则终止授权。
．如果製造商未在成员国设立公司，则授权代表应对有缺陷的设备承担相同的法律责任。
荷兰健康和青年护理检查局(IGJ)医疗器材註册(Farmatec)
1. 申请人：在荷兰成立的製造商或其授权代表。
2. 需註册的医疗器材：
．Ⅰ类医疗器材
．定制医疗器材
．体外诊断 (IVD)（所有风险等级）
3. 网页：https://english.farmatec.nl/
4.文件要求
．符合性声明 (DoC)：製造商的名称和地址、产品遵守的法规、签发日期和主管人员的签名、产品标识、授权代表的姓名和地址(如适用)、生产地点(如果适用)。
．CE证书：製造商的名称和地址、产品遵守的法规、签发日期和主管人员的签名、产品标识、生产地点(如果适用)
5.备註：
．若为第一次註册产品，须先完成註册公司资料。
．CE 证书必须由指定机构颁发
产品责任
1. 医疗器材的製造商或授权代表有法律义务在荷兰向健康和青年护理检查局(IGJ)报告涉及任何设备的严重事件，且必须将与医疗器材安全相关的纠正措施通知健康和青年护理检查局(IGJ)，包含报告严重事件和纠正措施 (FSCA)。
2. 报告方式：填写电子表格并保存，然后表单作为附件添加到电子邮件中，发送电子邮件至：meldpunt@igj.nl。
3. 报告项目：
．一般召回
．设计变更
．更改使用说明
．更改产品包装
4. 表格：
．纠正措施表现场安全纠正措施 (FSCA)
．安全通知表现场安全通知 (FSN)
．现场安全通知的澄清问题和答案
Yes. Medical devices sold in the Netherlands must be registered with the local manufacturer or authorized local representative before they can be placed on the market.
Authorized representative
1. If the manufacturer is outside the territory of a member state, the device may only be placed on the EU market if the manufacturer appoints a sole authorised representative.
2. The authorization designated to constitute an authorized representative is valid only when accepted in writing by the authorized representative, and is valid for at least all devices of the same general device group.
3. The authorized representative shall perform the tasks specified in the tasks agreed upon with the manufacturer. The authorised representative shall provide the competent authority with a copy of the power of attorney upon request. Authorization shall be required and the manufacturer shall allow an authorized representative to perform at least the following tasks in relation to the device it covers:
．Verify that the EU Declaration of Conformity and Technical File have been drafted and, where applicable, that the manufacturer has carried out the appropriate conformity assessment procedures.
．Keep copies of the technical documentation, the EU Declaration of Conformity and, if applicable, the relevant certificates, including any modifications and additions, for the use of the competent authorities.
．Comply with registration obligations and verify that the manufacturer has complied with registration obligations.
．Provide this competent authority with all the information and documents required to demonstrate the conformity of the device in the official EU language determined by the Member State concerned.
．Forward any request by the competent authority of the Member State where the authorized representative has its registered place of business to the manufacturer to obtain samples or access the device and to verify whether the competent authority has received the samples or has the right to access the device.
．Take any preventive or corrective action in cooperation with the competent authority to eliminate or, where unlikely, mitigate the risks posed by the device.
．Immediately notify manufacturers of complaints and reports of healthcare professionals, patients, and users of suspicious incidents related to the devices they are designated for use.
．The authorisation is terminated if the manufacturer acts in breach of its obligations under this Regulation.
．If the manufacturer does not set up a company in a member state, the authorised representative shall bear the same legal liability for defective device.
Netherlands Health and Youth Care Inspectorate (IGJ) Medical Device Registration (Farmatec)
1. Applicant: The manufacturer established in the Netherlands or its authorized representative.
2. Medical devices to be registered:
．Class I medical devices
．Custom Medical Devices
．In Vitro Diagnostics (IVD) (all risk classes)
3. URL: https://english.farmatec.nl/
4. Documentation requirements
．Declaration of Conformity (DoC): Manufacturer’s name and address, regulations to which the product complies, date of issue and signature of the competent person, product identification, name and address of authorized representative (if applicable), location of manufacture (if applicable).
．CE certificate: Manufacturer’s name and address, regulations to which the product complies, date of issue and signature of supervisor, product identification, production location (if applicable)
5. Remarks:
．If it is the first time to register a product, you must complete the registered company information first.
．CE certificate must be issued by a designated body
Product Liability
1. The manufacturer or authorised representative of a medical device is legally obliged to report serious incidents involving any device to the Health and Youth Care Inspection Agency (IGJ) in the Netherlands and must notify the Health and Youth Care Inspection of corrective actions related to the safety of the medical device Bureau (IGJ), which includes reporting of serious incidents and corrective actions (FSCA).
2. Report: Fill out the spreadsheet and save it, then add the form as an attachment to an email, send an email to: meldpunt@igj.nl.
3. Report items:
．General recall
．Design changes
．Change instructions for use
．Change product packaging
4. Forms:
．Corrective Action Table Site Safety Corrective Action (FSCA)
．Security Notification Table Field Security Notification (FSN)
．Clarification Questions and Answers for Field Safety Notifications
【参考连结】
https://business.gov.nl/regulation/medical-devices/
HLF-NL-35
HLF-NL-40
外国公司销售到荷兰医疗器材本身，进口前需要办理产品许可吗？如需要，哪个单位在管理？需要什麽文件？
申请程序为何？医疗器材包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？网页？
Do foreign companies need to apply for an approval before importing medical devices sold to Kingdom of the Netherlands? If yes, which authority is in charge? What documents are required? What is the application process? Do medical devices packaging and labeling require prior approval? Which languages are allowed? Website?
Evershine RD：
需要，须以荷兰或欧盟成员国之公司身分于欧盟网站完成 (EUDAMED医疗器材)註册，以及製造商或授权当地代表于荷兰健康和青年护理检查局(IGJ)完成医疗器材註册(Farmatec)
欧盟(EUDAMED)註册流程
1.角色註册(製造商/授权代表/进口商)
．公司名称/申请人名称
．联繫电话、Email
．国家、城市、街道、邮递区号等
2.UDI/设备註册
．製造商名称、地址
．风险等级
．测量功能(是/否)
．可重複用的手术器材(是/否)
．有源设备(是/否)
．识别设备型号
．技术文件或合格证书/声明
．设备数量
．使用单位
．临床规模
．附加产品说明
．一次性使用(是/否)
．最大重複使用次数
．是否需要灭菌
．含乳胶(是/否)
．CMR/内分泌干扰物
．严重警告或禁忌症
．医疗器材命名法 (CND) 代码等
3.证书和公告机构
．产品类别证书： 欧盟型式检验证书、欧盟技术文件证书、 欧盟产品验证证书。
．质量等级证书：欧盟质量管理体系证书、欧盟质量保证证书、 欧盟生产质量保证证书。
4.临床调查和性能研究(开发中)
5.警惕和上市后监督(开发中)
6.市场监督(开发中)
7.欧盟颁发的许可证有效期为5年。
荷兰健康和青年护理检查局(IGJ)医疗器材註册(Farmatec)
1. 申请人：在荷兰成立的製造商或其授权代表。
2. 需註册的医疗器材：
．Ⅰ类医疗器材
．定制医疗器材
．体外诊断 (IVD)（所有风险等级）
3. 网页：https://english.farmatec.nl/
4.文件要求
．符合性声明 (DoC)：製造商的名称和地址、产品遵守的法规、签发日期和主管人员的签名、产品标识、授权代表的姓名和地址(如适用)、生产地点(如果适用)。
．CE证书：製造商的名称和地址、产品遵守的法规、签发日期和主管人员的签名、产品标识、生产地点(如果适用)
5.备註：
．若为第一次註册产品，须先完成註册公司资料。
．CE 证书必须由指定机构颁发
标籤、使用说明和语言的要求
1.每个医疗设备和每个体外诊断设备 (IVD) 都必须附有清晰的标籤、使用说明，并在适用的情况下附有射频识别（RFID）或条形码。
2.标籤和使用说明中的信息必须根据未来用户的培训、知识进行调整。该信息也必须在製造商的网站上提供。
3.製造商提供的信息应採用国际认可的符号形式。
4.标籤上要求的信息应在设备本身上提供，并且必须不可磨灭、清晰易读，如果因为包装太小而不可行或不合适，则可能显示部分信息。
5.需要告知用户和/或其他人的残馀风险应作为限制、禁忌症、预防措施或警告包含在製造商提供的信息中。
6. 标籤应包含以下所有内容：
．装置的名称/商品名称。
．用户识别必需的详细信息、包装内容以及器材的预期用途。
．製造商的名称、註册商号或註册商标及其註册营业地点的地址。
．如果製造商的註册营业地点在欧盟以外，须标示授权代表的姓名和授权代表的註册营业地点的地址。
．药用物质，包括人类血液或血浆衍生物(如果适用) 。
．人类来源的组织或细胞，或其衍生物(如果适用) 。
．动物来源的组织或细胞，或其衍生物(如果适用) 。
．设备的批号或序列号，前面有 LOT NUMBER 或 SERIAL NUMBER 字样或等效符号，视情况而定。
．UDI承运人。
．明确说明安全使用或植入器材的时间限制，在相关的情况下至少以年和月表示。如果可以安全使用则为製造日期，该製造日期可以作为批号或序列号的一部分包含在内，前提是该日期可以清楚地被识别。
．适用的任何特殊储存和/或处理条件的说明。
．如果器材是无菌供货的，说明其无菌状态和灭菌方法。
．警告或预防措施。
．无菌器材的包装信息：无菌包装的标誌、声明、消毒方法、製造商的名称和地址、设备的描述、专门用于临床研究(如果适用)、定制设备(如果适用)、製造的月份和年份、明确指示使用或植入的时间限制、使用说明、检查是否在使用前损坏或无意打开的说明。
7. 使用说明应包含以下所有内容：
．器材的预期用途，并明确说明适应症、禁忌症、患者目标群体和预期用户。
．预期的临床益处 (如果适用)。
．安全性和临床表现总结(如果适用)。
．装置的性能特徵。
．允许医疗保健专业人员验证设备是否合适并选择相应软件和附件的信息(如果适用)。
．任何残馀风险、禁忌症和任何不良副作用，包括在这方面向患者传达的信息。
．用户正确使用设备所需的规格，例如如果该设备具有测量功能，其声称的准确度。
．在设备准备好使用之前或使用期间对设备进行的任何准备处理或处理的详细信息，例如灭菌、最终组装、校准等，包括确保患者安全所需的消毒水平和所有可用方法达到这些消毒水平。
．对设备用户和/或其他人的特殊设施、特殊培训或特殊资格的任何．要求。
．验证设备是否正确安装并准备好按照製造商的预期安全运行所需的信息。
．如果设备是无菌供应的，在使用前无菌包装损坏或无意打开时的说明。
．如果设备以非无菌形式提供，目的是在使用前对其进行灭菌，则适当的灭菌说明。
．如果器材是可重複使用的，关于允许重複使用的适当过程的信息，包括清洁、消毒、包装，以及在适当情况下，适用于放置器材的成员国或成员国的经验证的再灭菌方法在市场上。应提供信息以识别何时不应再使用该设备，例如：材料退化迹像或最大允许重複使用次数。
．设备只有在製造商负责修復以符合一般安全和性能要求时才能重複使用(如果适用)。
．如果设备标有其为一次性使用的指示，则有关製造商已知的已知特性和技术因素的信息，如果该设备被重複使用，可能会造成风险。该信息应基于製造商风险管理文件的特定部分，其中应详细说明此类特徵和技术因素。
．与其他设备和/或通用设备一起使用的设备：识别此类装置或设备的信息，以获得安全组合、设备和设备组合的任何已知限制的信息。
．关于发射辐射的性质、类型和适当情况下的强度和分佈的详细信息。
．在使用设备期间保护患者、用户或其他人免受意外辐射的方法。
．如果器材由拟引入人体的物质或物质组合组成，并被人体吸收或局部分散在人体中，在适当的情况下，警告和预防措施与以下内容有关器材及其代谢产物与其他器材、药品和其他物质相互作用的一般概况，以及与过量服用有关的禁忌症、不良副作用和风险。
．对于可植入设备，关于患者可能接触的材料和物质的总体定性和定量信息。
．为便于安全处置设备、其附件和与之一起使用的耗材（如有）而採取的警告或预防措施。
．对于供非专业人士使用的设备，用户应谘询医疗保健专业人员的情况。
．通知用户和/或患者，任何与设备有关的严重事件都应报告给製造商和用户和/或患者所在成员国的主管当局。
．对于包含电子可编程系统的设备，包括软件或本身就是设备的软件，有关硬件、IT网路特性和IT安全措施的最低要求，包括防止未经授权的访问。
8.在荷兰，标籤和使用说明上的信息必须使用荷兰语，应使用适合潜在用户的教育和知识的语言。如果可能，製造商还应以符号形式提供信息。如果确定医疗设备和 IVD 将仅由精通英语的医疗保健专业人员使用，可以仅以英语提供信息。
9.製造商的地址必须在标籤上註明。如果製造商来自欧盟以外，则（授权）代表的地址也必须在标籤、包装或使用说明中。
Yes. It is necessary to complete the registration on the EU website (EUDAMED medical device) as a company in the Netherlands or an EU member state, and the manufacturer or authorized local representative to complete the medical device registration (Farmatec) at the Netherlands Health and Youth Care Inspection Agency (IGJ).
EU (EUDAMED) registration process
1. Role Registration (Manufacturer / Authorized Representative / Importer)
．Company name / Applicant name
．Contact phone number, Email
．Country, city, street, postal code, etc.
2.UDI/device registration
．Manufacturer’s name, address
．Risk class
．Measuring function (yes/no)
．Reusable surgical instruments (yes/no)
．Active device (yes/no)
．Identify the device model
．Technical file or certificate/declaration of conformity
．Number of devices
．Use unit
．Clinical scale
．Additional product descriptions
．Disposable (yes/no)
．Maximum number of repetitions
．Does it need to be sterilized?
．Latex-containing (yes/no)
．CMR/endocrine disruptor
．Severe warnings or contraindications
．Medical Device Nomenclature (CND) codes and more
3. Certification and Notified Body
．Product Category Certificate: EU Type Inspection Certificate, EU Technical Document Certificate, EU Product Verification Certificate.
．Quality grade certificates: EU quality management system certificate, EU quality assurance certificate, EU production quality assurance certificate.
4. Clinical investigations and performance studies (in development)
5. Vigilance and post-market surveillance (in development)
6. Market surveillance (under development)
7. EU-issued licenses are valid for 5 years.
Netherlands Health and Youth Care Inspectorate (IGJ) Medical Device Registration (Farmatec)
1. Applicant: The manufacturer established in the Netherlands or its authorized representative.
2. Medical devices to be registered:
．Class I medical devices
．Custom Medical Devices
．In Vitro Diagnostics (IVD) (all risk classes)
3. URL: https://english.farmatec.nl/
4. Documentation requirements
．Declaration of Conformity (DoC): Manufacturer’s name and address, regulations to which the product complies, date of issue and signature of the competent person, product identification, name and address of authorized representative (if applicable), location of manufacture (if applicable).
．CE certificate: Manufacturer’s name and address, regulations to which the product complies, date of issue and signature of supervisor, product identification, production location (if applicable)
5. Remarks:
．If it is the first time to register a product, you must complete the registered company information first.
．CE certificate must be issued by a designated body
Labeling, Instructions for Use and Language Requirements
1. Each medical device and each in vitro diagnostic device (IVD) must be clearly labelled, instructions for use, and, where applicable, radio frequency identification (RFID) or barcodes.
2. The information in the labels and instructions for use must be adjusted based on the training and knowledge of future users. This information must also be provided on the manufacturer’s website.
3. The information provided by the manufacturer should be in the form of an internationally recognized symbol.
4. The information required on the label should be provided on the device itself and must be indelible, legible, and may be partially displayed if the package is too small to be feasible or appropriate.
5. Residual risks that need to be communicated to users and/or others should be included in the information provided by the manufacturer as limitations, contraindications, precautions or warnings.
6. Labels should contain all of the following:
．The name of the device/trade name.
．User identification of the necessary details, package contents and intended use of the device.
．The manufacturer’s name, registered trade name or registered trademark and the address of its registered place of business.
．If the manufacturer’s registered place of business is outside the EU, the name of the authorized representative and the address of the authorized representative’s registered place of business must be indicated.
．Medicinal substances, including derivatives of human blood or plasma (if applicable).
．Tissues or cells of human origin, or derivatives thereof (if applicable).
．Tissues or cells of animal origin, or derivatives thereof (if applicable).
．The lot or serial number of the device, preceded by the words LOT NUMBER or SERIAL NUMBER or equivalent, as appropriate.
．UDI carrier.
．Clearly state the time limit for the safe use or implantation of the device, expressed in at least years and months where relevant. The date of manufacture if it is safe to use, which may be included as part of the batch or serial number, provided that the date can be clearly identified.
．A statement of any special storage and/or handling conditions that apply.
．If device is supplied sterile, state its sterile state and method of sterilization.
．Warning or precautionary measure.
．Packaging Information for Sterile Devices: Sterile packaging markings, declarations, method of sterilization, manufacturer’s name and address, description of the device, dedicated to clinical research (if applicable), custom device (if applicable), month and year of manufacture, Clearly indicate time limits for use or implantation, instructions for use, instructions to check for damage or unintentional opening prior to use.
7. Instructions for use shall include all of the following:
．The intended use of the device, with a clear indication of indications, contraindications, target patient groups and intended users.
．Expected clinical benefit (if applicable).
．Summary of safety and clinical presentation (if applicable).
．Performance characteristics of the device.
．Information that allows healthcare professionals to verify the suitability of the device and select appropriate software and accessories, if applicable.
．Any residual risks, contraindications, and any adverse side effects, including messages communicated to patients in this regard.
．Specifications required by the user to use the device properly, such as its claimed accuracy if the device has a measurement capability.
．If the device is supplied sterile, instructions if the sterile packaging is damaged or unintentionally opened prior to use.
．Appropriate sterilization instructions if the device is provided in a non-sterile form with the intention of sterilizing it prior to use.
．If the device is reusable, information on the appropriate processes to allow reuse, including cleaning, sterilization, packaging, and, where appropriate, validated resterilization methods for the Member State in which the device is placed or the Member State in which the device is placed on the market superior. Information should be provided to identify when the device should no longer be used, e.g. signs of material degradation or maximum allowable number of reuses.
．Device may only be reused (if applicable) if it is repaired by the manufacturer to meet general safety and performance requirements.
．If the device is marked with an indication that it is for single use, information about known characteristics and technical factors known to the manufacturer that could pose a risk if the device is reused. This information should be based on a specific section of the manufacturer’s risk management documentation, which should detail such characteristics and technical factors.
．Device used with other device and/or general purpose device: Information identifying such devices or device for information on security combinations, device and any known limitations of combinations of device.
．Detailed information on the nature, type and where appropriate intensity and distribution of emitted radiation.
．Methods of protecting patients, users, or others from accidental radiation during device use.
．If the device consists of a substance or combination of substances intended for introduction into the human body and is absorbed or locally dispersed in the human body, where appropriate, warnings and precautions related to the device and its metabolites and other devices, medicines and other General profile of substance interactions, as well as contraindications, adverse side effects and risks associated with overdose.
．For implantable devices, general qualitative and quantitative information about materials and substances to which the patient may be exposed.
．Warnings or precautions for the safe disposal of the device, its accessories and consumables (if any) used with it.
．For devices intended for non-professional use, users should consult a healthcare professional.
．Inform the user and/or the patient that any serious event related to the device should be reported to the competent authority of the Member State in which the manufacturer and the user and/or the patient are located.
．Minimum requirements for hardware, IT network characteristics and IT security measures, including protection against unauthorized access, for device incorporating electronically programmable systems, including software or software that is itself device.
8. In the Netherlands, information on labels and directions for use must be in Dutch, in a language appropriate to the education and knowledge of the potential user. If possible, the manufacturer should also provide information in symbolic form. Information may be provided in English only if it is determined that the medical device and IVD will only be used by health care professionals who are proficient in English.
9. The address of the manufacturer must be indicated on the label. If the manufacturer is from outside the EU, the (authorized) representative’s address must also be on the label, packaging or instructions for use.
【参考连结】
https://ec.europa.eu/tools/eudamed/#/screen/home
https://business.gov.nl/regulation/medical-devices/
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX%3A02017R0745%2D20200424&from=EN
HLF-NL-45
HLF-NL-50
外国公司可以用自己名义申请办理产品许可吗？如需要，哪个单位在管理？需要什麽文件？
申请程序为何？医疗器材包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？网页？
Can a foreign company apply for a product license by its own name? If yes, which authority is in charge? What documents are required? What is the application process? Do medical devices packaging and labeling require prior approval? Which languages are allowed?Website?
Evershine RD：
需以荷兰或欧盟成员国之公司身分于欧盟网站完成 (EUDAMED医疗器材)註册，以及製造商或授权当地代表于荷兰健康和青年护理检查局(IGJ)完成医疗器材註册(Farmatec)
欧盟(EUDAMED)註册流程
1.角色註册(製造商/授权代表/进口商)
．公司名称/申请人名称
．联繫电话、Email
．国家、城市、街道、邮递区号等
2.UDI/设备註册
．製造商名称、地址
．风险等级
．测量功能(是/否)
．可重複用的手术器材(是/否)
．有源设备(是/否)
．识别设备型号
．技术文件或合格证书/声明
．设备数量
．使用单位
．临床规模
．附加产品说明
．一次性使用(是/否)
．最大重複使用次数
．是否需要灭菌
．含乳胶(是/否)
．CMR/内分泌干扰物
．严重警告或禁忌症
．医疗器材命名法 (CND) 代码等
3.证书和公告机构
．产品类别证书： 欧盟型式检验证书、欧盟技术文件证书、 欧盟产品验证证书。
．质量等级证书：欧盟质量管理体系证书、欧盟质量保证证书、 欧盟生产质量保证证书。
4.临床调查和性能研究(开发中)
5.警惕和上市后监督(开发中)
6.市场监督(开发中)
7.欧盟颁发的许可证有效期为5年。
荷兰健康和青年护理检查局(IGJ)医疗器材註册(Farmatec)
1. 申请人：在荷兰成立的製造商或其授权代表。
2. 需註册的医疗器材：
．Ⅰ类医疗器材
．定制医疗器材
．体外诊断 (IVD)（所有风险等级）
3. 网页：https://english.farmatec.nl/
4.文件要求
．符合性声明 (DoC)：製造商的名称和地址、产品遵守的法规、签发日期和主管人员的签名、产品标识、授权代表的姓名和地址(如适用)、生产地点(如果适用)。
．CE证书：製造商的名称和地址、产品遵守的法规、签发日期和主管人员的签名、产品标识、生产地点(如果适用)
5.备註：
．若为第一次註册产品，须先完成註册公司资料。
．CE 证书必须由指定机构颁发
标籤、使用说明和语言的要求
1.每个医疗设备和每个体外诊断设备 (IVD) 都必须附有清晰的标籤、使用说明，并在适用的情况下附有射频识别（RFID）或条形码。
2.标籤和使用说明中的信息必须根据未来用户的培训、知识进行调整。该信息也必须在製造商的网站上提供。
3.製造商提供的信息应採用国际认可的符号形式。
4.标籤上要求的信息应在设备本身上提供，并且必须不可磨灭、清晰易读，如果因为包装太小而不可行或不合适，则可能显示部分信息。
5.需要告知用户和/或其他人的残馀风险应作为限制、禁忌症、预防措施或警告包含在製造商提供的信息中。
6. 标籤应包含以下所有内容：
．装置的名称/商品名称。
．用户识别必需的详细信息、包装内容以及器材的预期用途。
．製造商的名称、註册商号或註册商标及其註册营业地点的地址。
．如果製造商的註册营业地点在欧盟以外，须标示授权代表的姓名和授权代表的註册营业地点的地址。
．药用物质，包括人类血液或血浆衍生物(如果适用) 。
．人类来源的组织或细胞，或其衍生物(如果适用) 。
．动物来源的组织或细胞，或其衍生物(如果适用) 。
．设备的批号或序列号，前面有 LOT NUMBER 或 SERIAL NUMBER 字样或等效符号，视情况而定。
．UDI承运人。
．明确说明安全使用或植入器材的时间限制，在相关的情况下至少以年和月表示。如果可以安全使用则为製造日期，该製造日期可以作为批号或序列号的一部分包含在内，前提是该日期可以清楚地被识别。
．适用的任何特殊储存和/或处理条件的说明。
．如果器材是无菌供货的，说明其无菌状态和灭菌方法。
．警告或预防措施。
．无菌器材的包装信息：无菌包装的标誌、声明、消毒方法、製造商的名称和地址、设备的描述、专门用于临床研究(如果适用)、定制设备(如果适用)、製造的月份和年份、明确指示使用或植入的时间限制、使用说明、检查是否在使用前损坏或无意打开的说明。
7. 使用说明应包含以下所有内容：
．器材的预期用途，并明确说明适应症、禁忌症、患者目标群体和预期用户。
．预期的临床益处 (如果适用)。
．安全性和临床表现总结(如果适用)。
．装置的性能特徵。
．允许医疗保健专业人员验证设备是否合适并选择相应软件和附件的信息(如果适用)。
．任何残馀风险、禁忌症和任何不良副作用，包括在这方面向患者传达的信息。
．用户正确使用设备所需的规格，例如如果该设备具有测量功能，其声称的准确度。
．在设备准备好使用之前或使用期间对设备进行的任何准备处理或处理的详细信息，例如灭菌、最终组装、校准等，包括确保患者安全所需的消毒水平和所有可用方法达到这些消毒水平。
．对设备用户和/或其他人的特殊设施、特殊培训或特殊资格的任何．要求。
．验证设备是否正确安装并准备好按照製造商的预期安全运行所需的信息。
．如果设备是无菌供应的，在使用前无菌包装损坏或无意打开时的说明。
．如果设备以非无菌形式提供，目的是在使用前对其进行灭菌，则适当的灭菌说明。
．如果器材是可重複使用的，关于允许重複使用的适当过程的信息，包括清洁、消毒、包装，以及在适当情况下，适用于放置器材的成员国或成员国的经验证的再灭菌方法在市场上。应提供信息以识别何时不应再使用该设备，例如：材料退化迹像或最大允许重複使用次数。
．设备只有在製造商负责修復以符合一般安全和性能要求时才能重複使用(如果适用)。
．如果设备标有其为一次性使用的指示，则有关製造商已知的已知特性和技术因素的信息，如果该设备被重複使用，可能会造成风险。
该信息应基于製造商风险管理文件的特定部分，其中应详细说明此类特徵和技术因素。
．与其他设备和/或通用设备一起使用的设备：识别此类装置或设备的信息，以获得安全组合、设备和设备组合的任何已知限制的信息。
．关于发射辐射的性质、类型和适当情况下的强度和分佈的详细信息。
．在使用设备期间保护患者、用户或其他人免受意外辐射的方法。
．如果器材由拟引入人体的物质或物质组合组成，并被人体吸收或局部分散在人体中，在适当的情况下，警告和预防措施与以下内容有关器材及其代谢产物与其他器材、药品和其他物质相互作用的一般概况，以及与过量服用有关的禁忌症、不良副作用和风险。
．对于可植入设备，关于患者可能接触的材料和物质的总体定性和定量信息。
．为便于安全处置设备、其附件和与之一起使用的耗材（如有）而採取的警告或预防措施。
．对于供非专业人士使用的设备，用户应谘询医疗保健专业人员的情况。
．通知用户和/或患者，任何与设备有关的严重事件都应报告给製造商和用户和/或患者所在成员国的主管当局。
．对于包含电子可编程系统的设备，包括软件或本身就是设备的软件，有关硬件、IT网路特性和IT安全措施的最低要求，包括防止未经授权的访问。
8.在荷兰，标籤和使用说明上的信息必须使用荷兰语，应使用适合潜在用户的教育和知识的语言。如果可能，製造商还应以符号形式提供信息。如果确定医疗设备和 IVD 将仅由精通英语的医疗保健专业人员使用，可以仅以英语提供信息。
9.製造商的地址必须在标籤上註明。如果製造商来自欧盟以外，则（授权）代表的地址也必须在标籤、包装或使用说明中。
It is necessary to complete the registration on the EU website (EUDAMED medical device) as a company in the Netherlands or an EU member state, and the manufacturer or authorized local representative to complete the medical device registration (Farmatec) at the Netherlands Health and Youth Care Inspection Agency (IGJ).
EU (EUDAMED) registration process
1. Role Registration (Manufacturer / Authorized Representative / Importer)
．Company name / Applicant name
．Contact phone number, Email
．Country, city, street, postal code, etc.
2.UDI/device registration
．Manufacturer’s name, address
．Risk class
．Measuring function (yes/no)
．Reusable surgical instruments (yes/no)
．Active device (yes/no)
．Identify the device model
．Technical file or certificate/declaration of conformity
．Number of devices
．Use unit
．Clinical scale
．Additional product descriptions
．Disposable (yes/no)
．Maximum number of repetitions
．Does it need to be sterilized?
．Latex-containing (yes/no)
．CMR/endocrine disruptor
．Severe warnings or contraindications
．Medical Device Nomenclature (CND) codes and more
3. Certification and Notified Body
．Product Category Certificate: EU Type Inspection Certificate, EU Technical Document Certificate, EU Product Verification Certificate.
．Quality grade certificates: EU quality management system certificate, EU quality assurance certificate, EU production quality assurance certificate.
4. Clinical investigations and performance studies (in development)
5. Vigilance and post-market surveillance (in development)
6. Market surveillance (under development)
7. EU-issued licenses are valid for 5 years.
Netherlands Health and Youth Care Inspectorate (IGJ) Medical Device Registration (Farmatec)
1. Applicant: The manufacturer established in the Netherlands or its authorized representative.
2. Medical devices to be registered:
．Class I medical devices
．Custom Medical Devices
．In Vitro Diagnostics (IVD) (all risk classes)
3. URL: https://english.farmatec.nl/
4. Documentation requirements
．Declaration of Conformity (DoC): Manufacturer’s name and address, regulations to which the product complies, date of issue and signature of the competent person, product identification, name and address of authorized representative (if applicable), location of manufacture (if applicable).
．CE certificate: Manufacturer’s name and address, regulations to which the product complies, date of issue and signature of supervisor, product identification, production location (if applicable)
5. Remarks:
．If it is the first time to register a product, you must complete the registered company information first.
．CE certificate must be issued by a designated body
Labeling, Instructions for Use and Language Requirements
1. Each medical device and each in vitro diagnostic device (IVD) must be clearly labelled, instructions for use, and, where applicable, radio frequency identification (RFID) or barcodes.
2. The information in the labels and instructions for use must be adjusted based on the training and knowledge of future users. This information must also be provided on the manufacturer’s website.
3. The information provided by the manufacturer should be in the form of an internationally recognized symbol.
4. The information required on the label should be provided on the device itself and must be indelible, legible, and may be partially displayed if the package is too small to be feasible or appropriate.
5. Residual risks that need to be communicated to users and/or others should be included in the information provided by the manufacturer as limitations, contraindications, precautions or warnings.
6. Labels should contain all of the following:
．The name of the device/trade name.
．User identification of the necessary details, package contents and intended use of the device.
．The manufacturer’s name, registered trade name or registered trademark and the address of its registered place of business.
．If the manufacturer’s registered place of business is outside the EU, the name of the authorized representative and the address of the authorized representative’s registered place of business must be indicated.
．Medicinal substances, including derivatives of human blood or plasma (if applicable).
．Tissues or cells of human origin, or derivatives thereof (if applicable).
．Tissues or cells of animal origin, or derivatives thereof (if applicable).
．The lot or serial number of the device, preceded by the words LOT NUMBER or SERIAL NUMBER or equivalent, as appropriate.
．UDI carrier.
．Clearly state the time limit for the safe use or implantation of the device, expressed in at least years and months where relevant. The date of manufacture if it is safe to use, which may be included as part of the batch or serial number, provided that the date can be clearly identified.
．A statement of any special storage and/or handling conditions that apply.
．If device is supplied sterile, state its sterile state and method of sterilization.
．Warning or precautionary measure.
．Packaging Information for Sterile Devices: Sterile packaging markings, declarations, method of sterilization, manufacturer’s name and address, description of the device, dedicated to clinical research (if applicable), custom device (if applicable), month and year of manufacture, Clearly indicate time limits for use or implantation, instructions for use, instructions to check for damage or unintentional opening prior to use.
7. Instructions for use shall include all of the following:
．The intended use of the device, with a clear indication of indications, contraindications, target patient groups and intended users.
．Expected clinical benefit (if applicable).
．Summary of safety and clinical presentation (if applicable).
．Performance characteristics of the device.
．Information that allows healthcare professionals to verify the suitability of the device and select appropriate software and accessories, if applicable.
．Any residual risks, contraindications, and any adverse side effects, including messages communicated to patients in this regard.
．Specifications required by the user to use the device properly, such as its claimed accuracy if the device has a measurement capability.
．If the device is supplied sterile, instructions if the sterile packaging is damaged or unintentionally opened prior to use.
．Appropriate sterilization instructions if the device is provided in a non-sterile form with the intention of sterilizing it prior to use.
．If the device is reusable, information on the appropriate processes to allow reuse, including cleaning, sterilization, packaging, and, where appropriate, validated resterilization methods for the Member State in which the device is placed or the Member State in which the device is placed on the market superior. Information should be provided to identify when the device should no longer be used, e.g. signs of material degradation or maximum allowable number of reuses.
．Device may only be reused (if applicable) if it is repaired by the manufacturer to meet general safety and performance requirements.
．If the device is marked with an indication that it is for single use, information about known characteristics and technical factors known to the manufacturer that could pose a risk if the device is reused. This information should be based on a specific section of the manufacturer’s risk management documentation, which should detail such characteristics and technical factors.
．Device used with other device and/or general purpose device: Information identifying such devices or device for information on security combinations, device and any known limitations of combinations of device.
．Detailed information on the nature, type and where appropriate intensity and distribution of emitted radiation.
．Methods of protecting patients, users, or others from accidental radiation during device use.
．If the device consists of a substance or combination of substances intended for introduction into the human body and is absorbed or locally dispersed in the human body, where appropriate, warnings and precautions related to the device and its metabolites and other devices, medicines and other General profile of substance interactions, as well as contraindications, adverse side effects and risks associated with overdose.
．For implantable devices, general qualitative and quantitative information about materials and substances to which the patient may be exposed.
．Warnings or precautions for the safe disposal of the device, its accessories and consumables (if any) used with it.
．For devices intended for non-professional use, users should consult a healthcare professional.
．Inform the user and/or the patient that any serious event related to the device should be reported to the competent authority of the Member State in which the manufacturer and the user and/or the patient are located.
．Minimum requirements for hardware, IT network characteristics and IT security measures, including protection against unauthorized access, for device incorporating electronically programmable systems, including software or software that is itself device.
8. In the Netherlands, information on labels and directions for use must be in Dutch, in a language appropriate to the education and knowledge of the potential user. If possible, the manufacturer should also provide information in symbolic form. Information may be provided in English only if it is determined that the medical device and IVD will only be used by health care professionals who are proficient in English.
9. The address of the manufacturer must be indicated on the label. If the manufacturer is from outside the EU, the (authorized) representative’s address must also be on the label, packaging or instructions for use.
【参考连结】
https://ec.europa.eu/tools/eudamed/#/screen/home
https://business.gov.nl/regulation/medical-devices/
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX%3A02017R0745%2D20200424&from=EN
HLF-NL-55
HLF-NL-60
经过核准登记的医疗器材，进口到荷兰要检附什麽文件？经过什麽手续？
在销售时要向各地的卫生福利部相关机构事先或事后准备吗？网页？
What documents are required when importing approved medical devices into Kingdom of the Netherlands?
What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
贴有 CE 认证标籤的产品可在所有欧洲经济共同体 (简称 EEC) 会员国国内自由贩售，不需经过其他国家产品检测。
欧盟以外地区製造的货品必须具备完整的海关申报书，才能在欧盟市场内自由贩卖。
希望进行贸易的企业和个人在必须在所有海关程序中使用经济经营者註册和识别号 (EORI)作为识别号。
EORI 编号是在整个欧盟范围内有效的运营商识别号， 医疗器材产品进口、销售时必须在产品上贴上CE合规标誌。
欧洲市场上的每一个医疗器材都必须有CE 标誌。CE 标誌意味着产品符合法律要求。
对于 I 类医疗器材（非无菌和/或非测量），评估产品是否符合医疗器材指令。
IIa、IIb 和 III 类医疗器材必须由独立权威机构（公告机构）进行检查。
如果该机构批准该产品，将收到 CE 证书，才能销售医疗设备。
商品进口荷兰需要确认以下项目
1.产品受到保护
进口产品应先确定是否受任何商标、设计、专利或版权法的约束。
2.货物允许
对于来自欧盟以外的货物，荷兰海关会检查是否遵守有关安全、健康、经济和环境的法规。
3.如果从欧洲经济区以外进口产品，须徵得生产商许可
如果生产商允许，能从欧洲经济区(EEA) 以外的国家进口和销售产品，未经许可的进口称为平行进口。
4.进口许可证
食品补充剂需要符合欧盟法规才能进口，无进口许可证。
5.检查货物符合商品法
在荷兰生产、准备或交易食品或其他消费品必须遵守商品法。该法案提供了关于公共卫生、产品安全、贸易公平和适当信息的一般规则。
6. 与供应商达成明确协议
签订销售合约、分销协议或代理协议，在其中明确说明责任、保证等问题达成的协议，并指明哪个国家/地区的法律将管辖商业关係。
7. 考虑产品责任
如果从欧盟以外进口产品在荷兰市场上使用并造成损害，需要作为进口商承担责任，进口商可以安排产品责任保险。
8.对包装材料的责任
如果在荷兰製造或进口包装或包装产品，有责任管理包装直到废物阶段（生产者责任）。
9.向海关申报货物
如果从欧盟以外的国家/地区进口商品，必须向海关申报。也可以让运输公司、物流服务提供商或海关代理执行。根据申报，海关将计算进出口关税。
10.缴纳进口税
将货物进口到荷兰时，需要缴纳各种税款（进口税、增值税、消费税等）。进口税的支付金额取决于产品的种类和原产国。
11.医疗器材需确认拥有CE标誌
海关
1. 经济经营者註册和识别
于荷兰海关註册取得EORI 编号
(网页：
https://www.belastingdienst.nl/wps/wcm/connect/en/customs/content/how-to-obtain-an-eori-number)
申请书内容：
．公司名称、地址、邮政编码、城镇/城市
．RSIN/BSN
．增值税识别号
．签名
2. 通过AGS 系统（荷兰语）进行货物进出口的电子申报。
申报单内容：
．姓名/公司名称、地址、邮政编码、城镇
．商会编号
．EORI 编号或 RSIN
．联繫人姓名
．海关业务、角色、电话号码
．声明
．14 天内的预期船舶数量
．船舶的长度以及相应的关税
．14 天内到期的总关税等
无销售许可证。
Products bearing the CE certification label can be sold freely in all European Economic Community (EEC) member states without the need to undergo product testing in other countries. Goods manufactured outside the EU must have a full customs declaration in order to be freely sold within the EU market. Businesses and individuals wishing to trade are required to use the Economic Operator Registration and Identification Number (EORI) as their identification number in all customs procedures. The EORI number is an operator identification number valid throughout the EU, and the CE compliance mark must be affixed to the product when medical device is imported or sold.
Every medical device on the European market must be CE marked. CE marking means that the product meets legal requirements. For Class I medical devices (non-sterile and/or non-measured), evaluate the product for compliance with the Medical Device Directive. Class IIa, IIb and III medical devices must be inspected by an independent authority (Notified Body). If the agency approves the product, it will receive a CE certificate before it can be sold as a medical device.
Commodities imported into the Netherlands need to confirm the following items:
1. Products are protected
Importing products should first determine if they are subject to any trademark, design, patent or copyright laws.
2. Goods allowed
For shipments from outside the EU, Dutch customs checks compliance with regulations regarding safety, health, economy and environment.
3. If the product is imported from outside the European Economic Area, a manufacturer’s license is required
If the manufacturer allows it to import and sell products from countries outside the European Economic Area (EEA), unauthorised importation is called parallel importation.
4. Import Licence
Food supplements need to comply with EU regulations to be imported without an import license.
5. Check that the goods comply with the Commodities Act
The production, preparation or trading of food or other consumer products in the Netherlands is subject to commodity law. The Act provides general rules regarding public health, product safety, trade fairness, and appropriate information.
6. Make a clear agreement with the supplier
Enter into a sales contract, distribution agreement, or agency agreement that clearly states the agreement reached on issues of liability, warranties, etc., and indicates which country’s law will govern the commercial relationship.
7. Consider product liability
If a product imported from outside the EU is used on the Dutch market and causes damage, it is liable as an importer, who can arrange product liability insurance.
8. Liability for packaging materials
If packaging or packaging products are manufactured or imported in the Netherlands, there is a responsibility to manage the packaging until the waste stage (producer responsibility).
9. Declaration of goods to customs
If you import goods from a country outside the EU, you must declare it to customs. It can also be performed by transport companies, logistics service providers or customs agents. Customs will calculate import and export duties based on the declaration.
10. Pay import duties
When importing goods into the Netherlands, various taxes (import duty, value added tax, excise duty, etc.) are required to be paid. The amount of import duty paid depends on the type and country of origin of the product.
11. Medical device needs to confirm that it has CE mark.
Customs
1. Economic Operator Registration and Identification
Registered with Dutch customs to obtain EORI number
(Web page:
https://www.belastingdienst.nl/wps/wcm/connect/en/customs/content/how-to-obtain-an-eori-number)
Application form content:
．Company Name, Address, Postal Code, Town/City
．RSIN/BSN
．VAT ID
．Sign
2. Electronic declaration of import and export of goods via the AGS system (in Dutch).
Declaration form content:
．Name/Company Name, Address, Postal Code, Town
．Chamber number
．EORI number or RSIN
．Contact name
．Customs operations, roles, phone numbers
．Statement
．Expected number of ships in 14 days
．The length of the vessel and the corresponding tariff
．Total duties due in 14 days etc.
No sales license.
【参考连结】
https://business.gov.nl/regulation/medical-devices/
HLF-NL-70
荷兰医疗器材审核机构，需要附上的实验室检验资料有哪些? 网页？
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
CE 标誌
在欧盟 (EU) 销售医疗器材，产品皆须要取得 CE 标誌：CE 标誌应明显、清晰、不可磨灭地贴在器材或其无菌包装上。
如果由于设备的性质而无法或不能保证这种粘贴，则应在包装上粘贴 CE 标誌。CE 标誌也应出现在任何使用说明和任何销售包装上。
1. CE 标誌应由以下形式的首字母“CE”组成：
2. 如果CE标誌缩小或放大，应遵守上述刻度图中给出的比例。
3. CE标誌的各个组成部分应具有基本相同的垂直尺寸，不得小于5mm。对于小型设备，可以免除此最小尺寸。
医疗器材依据其分类申请CE认证具备内容：
1. ClassI：自我宣告即可
2. ClassIIa/ClassIIb/ClassIII:须符合相对应之医疗器材指令，通过认证机构评鑑(Notified Body Conformity Assessment Procedure)，取得CE证书。
注意事项：
1. I 类（非无菌、非测量）需要符合上市后监控(PMS) 机制。
．製造商应依器材风险等级和医材分类，规划、建立、文件化、施行、维护与持续更新上市后监督系统，以确认产品生命週期间的安全与功效。
2. 除 I 类（非无菌、非测量）以外的所有设备，需要实施质量管理体系(QMS) 。
．产品在取得认证文件后才可印上CE标誌。製造商、代理或进口商经过内部设立的产品检测部门检测，或会邀请外部的验证机构测试产品实施品质管理，确保量产产品符合检验合格之样品。
3. I 类到 IIb 类，需要一份技术文件，II 类/AIMD 设备为设计档案。
．製造商或任何授权代表的姓名和地址
．产品的简要说明
．产品的标识，例如产品的序列号
．产品设计和製造所涉及的设施的名称和地址
．参与评估产品符合性的任何公告机构的名称和地址
．已遵循的合格评定程序的声明
．欧盟符合性声明
．标籤和使用说明
．产品符合的相关法规的声明
．识别声称符合的技术标准
．零件清单
．试验结果
4. IIa 类、IIb 类和 III 类器材的製造商应为每个器材准备一份定期安全更新报告（PSUR），并在与每个类别或器材组相关的情况下，总结后期分析的结果和结论。
5. 欧洲办事处或授权代表的名称和地址放在使用说明、外包装或设备标籤上。
6. 除 I 类（非无菌、非测量）以外的所有设备，其 QMS 和技术文件或设计档案皆必须由认证机构（欧洲当局认可的第三方审核医疗器材公司和产品）进行审核。
临床调查和性能研究
製造商将医疗器材或体外诊断医疗器材 (IVD) 投放市场之前必须首先进行临床评估。
对于医疗器材，这是一项临床研究，对于体外诊断医疗器材，这是一项性能研究。
需要进行临床调查，通知健康和青年监察局(IGJ) 对产品的安全性进行实验室测试。
1. 製造商必须向 人体受试者的研究中央委员会（CCMO） 註册任何涉及医疗器材的临床调查。
2. 通过在 ToetsingOnline 中填写表格註册调查。
3. 基本文件
．信函：申请信、製造商授权、如果製造商不在欧盟内，则由欧盟法定代表人授权。
．表格：评估和登记表、Eudamed 表格、通知终止调查表隔。
．议定书：研究方案、议定书修正案。
．产品信息：研究者手册 (IB) 、研究性医疗器材档案 (IMDD) 、由製造商（或其授权代表）队医疗器材安全性和性能声明。
．研究信息：同意书。
．问卷：问卷调查、病人日记、病人卡、其他。
．保险：WMO研究保险证书、复盖范围证明。
．简历：专家、调查员的简历。
．参与中心：名单、场地适宜性声明 (VGO) 或研究声明、首席研究员、每个参与中心的其他信息。
．经济补偿：研究对象的经济补偿、调查人员和参与中心的经济补偿。
．其他文件：其他当局的建议、其他欧盟成员国评估、临床试验协议、科学出版物、数据安全监察委员会 (DSMB)、其他信息、临床评估计划、个人数据处理的描述。
CE marking
The sale of medical devices in the European Union (EU) requires CE marking of products: the CE marking should be conspicuously, clearly and indelibly affixed to the device or its sterile packaging. If, due to the nature of the device, such affixing is not possible or warranted, the CE marking shall be affixed to the packaging. The CE marking should also appear on any instructions for use and on any sales packaging.
1. The CE marking shall consist of the initials “CE” in the following form:
2. If the CE marking is reduced or enlarged, the proportions given in the scale diagram above shall be observed.
3. The various components of the CE mark shall have substantially the same vertical dimension and shall not be less than 5mm. For small devices, this minimum size can be waived.
Medical devices applying for CE certification according to their classification have the following contents:
1. Class I: self-declaration is enough
2. ClassIIa/ClassIIb/ClassIII: Must comply with the corresponding medical device directives, pass the Notified Body Conformity Assessment Procedure, and obtain the CE certificate.
Precautions:
1. Category I (non-sterile, non-measured) requires compliance with post-market surveillance (PMS) mechanisms.
．Manufacturers should plan, establish, document, implement, maintain and continuously update post-market surveillance systems based on device risk levels and medical material classifications to confirm product safety and efficacy during the product life cycle.
2. All device other than Class I (non-sterile, non-measuring) requires the implementation of a quality management system (QMS).
．Products can only be printed with the CE mark after obtaining the certification documents. Manufacturers, agents or importers have been tested by the internal product testing department, or they may invite external verification agencies to test the products to implement quality management to ensure that the mass-produced products meet the samples that have passed the inspection.
3. For Class I to Class IIb, a technical file is required, and Class II/AIMD device is a design file.
．The name and address of the manufacturer or any authorized representative
． Brief description of the product
．Identification of the product, such as the product’s serial number
．The name and address of the facility involved in the design and manufacture of the product
．Name and address of any notified body involved in assessing product conformity
． Statement of conformity assessment procedures followed
．EU Declaration of Conformity
．Labels and Instructions for Use
．Statement of relevant regulations to which the product complies
．Identify technical standards claimed to be compliant
．Parts List
．test results
4. Manufacturers of Class IIa, IIb and III devices shall prepare a Periodic Safety Update Report (“PSUR”) for each device and, where relevant to each class or device group, summarizing the results and conclusions.
5. The name and address of the European office or authorized representative are placed on the instructions for use, on the outer packaging or on the device label.
6. For all devices other than Class I (non-sterile, non-measurement), their QMS and technical or design files must be reviewed by a certification body (a third-party audit of medical device companies and products recognized by European authorities).
Clinical investigations and performance studies
Before a manufacturer can place a medical device or in vitro diagnostic medical device (IVD) on the market, it must first conduct a clinical evaluation. For medical devices, this is a clinical study, and for in vitro diagnostic medical devices, this is a performance study. A clinical investigation is required to inform the Health and Youth Inspectorate (IGJ) to conduct laboratory testing of the product’s safety.
1. The manufacturer must register any clinical investigation involving a medical device with the Central Committee for Research in Human Subjects (CCMO).
2. Register for the survey by filling out the form in ToetsingOnline.
3. Basic documents
． Letter: Application letter, authorisation of the manufacturer, authorisation by the EU legal representative if the manufacturer is not located in the EU.
．Forms: Assessment and Registration Form, Eudamed Form, Notice of Termination Questionnaire Interval.
．Protocol: Study Protocol, Protocol Amendments.
．Product Information: Investigator Brochure (IB), Investigational Medical Device Dossier (IMDD), Medical Device Safety and Performance Statements made by the manufacturer (or its authorized representative).
．Study Information: Consent Form.
．Questionnaire: Questionnaire, patient diary, patient card, others.
． Insurance: WMO Research Insurance Certificate, Proof of Coverage.
． Resumes: Resumes of experts and investigators.
． Participating Centers: List, Site Suitability Statement (VGO) or Research Statement, Principal Investigator, other information for each participating center.
． Financial compensation: financial compensation for research subjects, financial compensation for investigators and participating centers.
．Other documents: Recommendations of other authorities, evaluations of other EU member states, clinical trial protocols, scientific publications, Data Safety Monitoring Board (DSMB), other information, clinical evaluation plan, description of personal data processing.
【参考连结】
https://europa.eu/youreurope/business/product-requirements/labels-markings/ce-marking/index_en.htm
https://english.igj.nl/medical-technology/market-authorisation/clinical-research
HLF-NL-75
荷兰医疗器材审核机构，能够接受海外检验机构的检验资料吗？假如是的话，有些被认可的机构？网页？
Evershine RD：
医疗器材的CE认证只有在欧盟网站公告的指定验证机构(欧盟境内)，才具备医疗器材的CE符合性证书发证资格。
HLF-NL-77
HLF-NL-80
外国子公司进口医疗器材后，如果委託荷兰的经销商销售，经销商需要医疗器材营业许可证吗？
假如医疗器材有品质瑕疵的话，外国子公司和经销商各自的责任为何？是连带责任吗？还是可以规范由外国子公司负责？
After a foreign subsidiary imports medical devices and entrusts a distributor in Kingdom of the Netherlands to sell it, does the distributor need a medical devices business license? What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects? Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?
Evershine RD：
经销商无须申请医疗器材营业许可证。
产品责任
1. 医疗器材的製造商或授权代表有法律义务在荷兰向健康和青年护理检查局(IGJ)报告涉及任何设备的严重事件，且必须将与医疗器材安全相关的纠正措施通知健康和青年护理检查局(IGJ)，包含报告严重事件和纠正措施 (FSCA)。
2. 报告方式：填写电子表格并保存，然后表单作为附件添加到电子邮件中，发送电子邮件至：meldpunt@igj.nl。
3. 报告项目：
．一般召回
．设计变更
．更改使用说明
．更改产品包装
4. 表格：
．纠正措施表现场安全纠正措施 (FSCA)
．安全通知表现场安全通知 (FSN)
．现场安全通知的澄清问题和答案
No business license is required.
Product Liability
1. The manufacturer or authorised representative of a medical device is legally obliged to report serious incidents involving any device to the Health and Youth Care Inspection Agency (IGJ) in the Netherlands and must notify the Health and Youth Care Inspection of corrective actions related to the safety of the medical device Bureau (IGJ), which includes reporting of serious incidents and corrective actions (FSCA).
2. Report: Fill out the spreadsheet and save it, then add the form as an attachment to an email, send an email to: meldpunt@igj.nl.
3. Report items:
．General recall
．Design changes
．Change instructions for use
．Change product packaging
4. Forms:
．Corrective Action Table Site Safety Corrective Action (FSCA)
．Security Notification Table Field Security Notification (FSN)
．Clarification Questions and Answers for Field Safety Notifications
【参考连结】
https://business.gov.nl/regulation/medical-devices/
HLF-NL-85
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