Netherland Medical Device Regulation QA
Email：ams4ww@evershinecpa.com
HLF-NL-10
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：
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.
【參考連結】
https://business.gov.nl/regulation/medical-devices/
HLF-NL-20
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：
無須申請營業特許證。
No business license is required.
【參考連結】
https://business.gov.nl/regulation/medical-devices/
HLF-NL-25
假如需要辦理，請問荷蘭有專業服務公司可以協助辦理醫療器材公司營業許可證？
Evershine RD：
無須申請營業特許證。
HLF-NL-30
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：
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
【參考連結】
https://business.gov.nl/regulation/medical-devices/
HLF-NL-35
假如需要辦理指派荷蘭公司擔任營業代理人，請問荷蘭有專業服務公司可以協助？
Evershine RD：
Dutchmed Group
https://dutchmed.nl/index.php/en/
GD
HLF-NL-40
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：
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.
【參考連結】
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
請問在荷蘭有哪些專業服務機構，可以協助辦理醫療器材產品許可證？
Evershine RD：
EMERGO
Freyr
https://medicaldevices.freyrsolutions.com/
HLF-NL-50
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：
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.
【參考連結】
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
請問在荷蘭有哪些專業服務機構，可以協助以外國公司名義辦理醫療器材產品許可證？
Evershine RD：
EMERGO
Freyr
https://medicaldevices.freyrsolutions.com/
HLF-NL-60
What documents are required when importing approved medical devices into Netherlands? What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
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.
【參考連結】
https://business.gov.nl/regulation/medical-devices/
HLF-NL-70
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
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.
【參考連結】
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
荷蘭醫療器材審核機構，能夠接受海外檢驗機構的檢驗資料嗎？假如是的話，有些被認可的機構？網頁？
Evershine RD：
醫療器材的CE認證只有在歐盟網站公告的指定驗證機構(歐盟境內)，才具備醫療器材的CE符合性證書發證資格。
HLF-NL-77
請問在荷蘭有哪些醫療器材檢驗機構可以提供醫療器材檢驗服務？網頁？
Evershine RD：
RVA (RvA) (荷蘭唯一檢驗認證機構)
HLF-NL-80
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：
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
【參考連結】
https://business.gov.nl/regulation/medical-devices/
HLF-NL-85
請問在荷蘭有哪些專精於醫療器材銷售與消費權益相關法律服務的業者？
Evershine RD：
CMS
Axon Lawyers
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