German medical device regulations QA
Email: fra4ww@evershinecpa.com
The Engaging Manager from Headquarter
Ms. Anna Wang, Speak German, English, and Chinese.
skype: burlinna
HLF-TW-10
What are the categories of medical devices in Germany? 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：
The EU divides medical devices into two categories:
1. Medical device: refers to any instrument, device, appliance, software, implant, reagent, material or other item, alone or in combination, for use in humans for one or more specific medical purposes.
．Diagnosis, prevention, monitoring, prediction, prognosis, treatment or mitigation of disease.
．Diagnosis, monitoring, treatment, mitigation or compensation of injury or disability.
．Investigation, replacement or modification of anatomical structures, physiological or pathological processes.
．It is applied to the in vitro examination of the human body, including organs, blood and tissues, and cannot achieve its main intended effect in the human body or in the human body by pharmacological, immunological or metabolic means, but its function can be assisted by these medical devices.
The following products shall also be considered medical devices:
．A device that controls or supports conception.
．Products specifically designed to clean, disinfect or sterilize medical devices.
2. In-vitro diagnostic medical device: refers to any medical device in the form of reagents, reagent products, calibrators, control materials, kits, instruments, equipment, equipment, software or systems in the form of reagents, reagent products, calibrators, control materials, kits, instruments, equipment, software or systems, used for in vitro examination of specimens from the human body , including blood and tissue.
．associated with a physiological or pathological process or state
．Associated with a congenital physical or mental disorder
．Associated with physical condition or predisposition to disease
．Identification of safety and compatibility with potential recipients
．predict treatment response
．Define or monitor treatment measures
Specimen containers should also be considered in vitro diagnostic medical devices.
The risk level is from low to high: Class I products need to be affixed with the CE mark, and self-declaration can be adopted.
Class II(a), Class II(b), Class III products to be affixed with the CE mark must be verified by an EU-designated certification body.
1. Class I: Non-sterile or non-measurable (low risk)
2. Class I: Sterile and capable of measuring (low/medium risk).
3. Class IIa (moderate risk)
4. Class IIb (medium/high risk)
5. Class III (High Risk)
The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte or BfArM) under the Federal Ministry of Health is Germany’s medical device regulator.
【參考連結】
https://www.bfarm.de/EN/Home/_node.html
HLF-TW-20
If a foreign company wants to sell medical devices in Germany, 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：
It is necessary to register in the EU and obtain a local sales certificate for sales.
Each economic operator (EU and non-EU manufacturers, authorised representatives, system/package producers and importers) must be registered with EUDAMED as a participant and provide the required information.
EUDAMED is made up of 6 interrelated modules and a public website:
1. Role registration (manufacturer/authorized representative/importer)
． Company Name/Applicant Name
． Contact number, Email
． Country, city, street, zip code, etc.
2.UDI/device registration
． Manufacturer’s name, address
． Risk level
． Measurement function (yes/no)
． Reusable surgical instruments (yes/no)
． Active device (yes/no)
． Identify the device model
． Technical file or certificate of conformity/declaration
． Equipment Quantity
． unit of use
． clinical scale
． Additional Product Description
． Single use (yes/no)
． Maximum number of reuses
． Does it need to be sterilized?
． Contains latex (yes/no)
． CMR/endocrine disruptor
． Serious Warnings or Contraindications
． Medical Device Nomenclature (CND) codes, etc.
3. Certificates and Notified Bodies
．Product category certificate: EU type inspection certificate, EU technical file certificate, EU product verification certificate.
．Quality certificate: EU quality management system certificate, EU quality assurance certificate, EU production quality assurance certificate.
4. Clinical investigation and performance study (in development)
5. Vigilance and post-market surveillance (in development)
6. Market surveillance (under development)
In Germany, the first time a medical device is placed on the German market must be registered with the competent authority of the corresponding federal state for free sale. Applications are informal but must be made in writing.
The application should state or contain:
1. Receiving country
2. If applicable, state the language version required: the free sales voucher is basically in German, the template is designed with two columns, the first column is German and the second column is German, French, Portuguese or Spanish (depending on the applicant) If no language version is specified, a German/English certificate will be issued.
3. Delivery address
4. Product List
． Item or catalog number
． product name
． UDI-DI
． Certificate of a higher-level product notified body
5. Documentation showing product marketability
．Class I: Relevant Declaration of Conformity
．Class II(a), Class II(b), Class III: In addition to the Declaration of Conformity, a copy of the Notified Body’s Declaration of Conformity is required.
【參考連結】
https://www.dimdi.de/dynamic/de/medizinprodukte/institutionen/landesbehoerden-inverkehrbringen/
HLF-TW-25
假如需要辦理，請問德國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：
TÜV
EMERGO
HLF-TW-30
If a foreign company wants to sell medical devices in Germany, can it assign a German 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：
It is necessary to register in the EU and obtain a local sales certificate for sales.
Each economic operator (EU and non-EU manufacturers, authorised representatives, system/package producers and importers) must be registered with EUDAMED as a participant and provide the required information.
EUDAMED is made up of 6 interrelated modules and a public website:
1. Role registration (manufacturer/authorized representative/importer)
． Company Name/Applicant Name
． Contact number, Email
． Country, city, street, zip code, etc.
2.UDI/device registration
． Manufacturer’s name, address
． Risk level
． Measurement function (yes/no)
． Reusable surgical instruments (yes/no)
． Active device (yes/no)
． Identify the device model
． Technical file or certificate of conformity/declaration
． Equipment Quantity
． unit of use
． clinical scale
． Additional Product Description
． Single use (yes/no)
． Maximum number of reuses
． Does it need to be sterilized?
． Contains latex (yes/no)
． CMR/endocrine disruptor
． Serious Warnings or Contraindications
． Medical Device Nomenclature (CND) codes, etc.
3. Certificates and Notified Bodies
．Product category certificate: EU type inspection certificate, EU technical file certificate, EU product verification certificate.
．Quality certificate: EU quality management system certificate, EU quality assurance certificate, EU production quality assurance certificate.
4. Clinical investigation and performance study (in development)
5. Vigilance and post-market surveillance (in development)
6. Market surveillance (under development)
When adverse events occur, the following persons are responsible (notification and recall):
1. The person responsible for the first time the device is placed on the market: the manufacturer.
2. If the manufacturer does not have a registered place of business in the European Economic Area and has appointed an authorised representative, the authorised representative is responsible.
3. If the medical device is imported into the European Economic Area by the importer without an authorized representative, the importer is the responsible person.
4. If the equipment is operated or used in a professional or commercial framework, the operator or user of the medical device is the responsible person.
5. Distributors, traders, and authorized medical or dental personnel who sell medical devices for personal use to patients or other non-professionals.
6. If the device is offered on the market under the name, registered trade name or registered trademark of a distributor, importer or other natural or legal people, unless the distributor or importer has reached an agreement with the manufacturer, the manufacturer is identified on the label as The manufacturer is also responsible for meeting the requirements of this regulation for the manufacturer, otherwise the trademark registrant shall bear the obligations due to the manufacturer.
【參考連結】
https://ec.europa.eu/tools/eudamed/#/screen/home
https://www.dimdi.de/dynamic/de/medizinprodukte/institutionen/landesbehoerden-inverkehrbringen/
https://www.bfarm.de/EN/Medical-devices/Applications-and-reports/_node.html
HLF-TW-35
假如需要辦理指派德國公司擔任營業代理人，請問德國有專業服務公司可以協助？
GMS
Evershine RD：
https://gms-logistic.com/en
TapMed
https://www.tapmedinternational.com
HLF-TW-40
Do foreign companies need to apply for an approval before importing medical devices sold to Germany?
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?
In addition to German, which other languages are allowed? Website?
Evershine RD：
It is necessary to register in the EU and obtain a local sales certificate for sales.
Each economic operator (EU and non-EU manufacturers, authorised representatives, system/package producers and importers) must be registered with EUDAMED as a participant and provide the required information.
EUDAMED is made up of 6 interrelated modules and a public website:
1. Role registration (manufacturer/authorized representative/importer)
． Company Name/Applicant Name
． Contact number, Email
． Country, city, street, zip code, etc.
2.UDI/device registration
． Manufacturer’s name, address
． Risk level
． Measurement function (yes/no)
． Reusable surgical instruments (yes/no)
． Active device (yes/no)
． Identify the device model
． Technical file or certificate of conformity/declaration
． Equipment Quantity
． unit of use
． clinical scale
． Additional Product Description
． Single use (yes/no)
． Maximum number of reuses
． Does it need to be sterilized?
． Contains latex (yes/no)
． CMR/endocrine disruptor
． Serious Warnings or Contraindications
． Medical Device Nomenclature (CND) codes, etc.
3. Certificates and Notified Bodies
．Product category certificate: EU type inspection certificate, EU technical file certificate, EU product verification certificate.
．Quality certificate: EU quality management system certificate, EU quality assurance certificate, EU production quality assurance certificate.
4. Clinical investigation and performance study (in development)
5. Vigilance and post-market surveillance (in development)
6. Market surveillance (under development)
In Germany, the first time a medical device is placed on the German market must be registered with the competent authority of the corresponding federal state for free sale.
Applications are informal but must be made in writing.
The application should state or contain:
1. Receiving country
2. If applicable, state the language version required: the free sales voucher is basically in German, the template is designed with two columns, the first column is German and the second column is German, French, Portuguese or Spanish (depending on the applicant) If no language version is specified, a German/English certificate will be issued.
3. Delivery address
4. Product List
． Item or catalog number
． product name
． UDI-DI
． Certificate of a higher-level product notified body
5. Documentation showing product marketability
． Class I: Relevant Declaration of Conformity
．Class II(a), Class II(b), Class III: In addition to the Declaration of Conformity, a copy of the Notified Body’s Declaration of Conformity is required.
Labels and Instructions for Use:
1. Each product must be accompanied by all safety and performance information necessary for safe use, identification of the product, manufacturer or authorized representative.
2. National language requirements must be taken into account with regard to labels and instructions for use in German, and instructions for use in technical documentation should be in each relevant national language.
3. The label should state that the product is a “medical device”.
4. The information provided by the manufacturer shall be in internationally recognized symbols.
5. It is recommended to check the translation, the manufacturer is liable for personal injury to the patient or others due to incorrect or misleading translation.
【參考連結】
https://www.dimdi.de/dynamic/de/medizinprodukte/institutionen/landesbehoerden-inverkehrbringen/
https://www.dimdi.de/dynamic/de/medizinprodukte/institutionen/landesbehoerden-inverkehrbringen/
HLF-TW-45
請問在德國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：
TÜV
EMERGO
HLF-TW-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?
In addition to German, which other languages are allowed? Website?
Evershine RD：
If equipment is offered on the EU market under the name, registered trade name or registered trade mark of a distributor, importer or other natural or legal person, unless the distributor or importer has agreed with the manufacturer, the manufacturer is identified on the label as manufacturing Trademark registrants shall be responsible for meeting the requirements of this regulation for manufacturers, otherwise the trademark registrant shall undertake the obligations due to the manufacturer.
Those who register trademarks need to have a registered business place in the European Economic Area, and those who do not have a place of business can appoint an authorized representative.
Each economic operator (EU and non-EU manufacturers, authorised representatives, system/package producers and importers) must be registered with EUDAMED as a participant and provide the required information.
EUDAMED is made up of 6 interrelated modules and a public website:
1. Role registration (manufacturer/authorized representative/importer)
． Company Name/Applicant Name
． Contact number, Email
． Country, city, street, zip code, etc.
2.UDI/device registration
． Manufacturer’s name, address
． Risk level
． Measurement function (yes/no)
． Reusable surgical instruments (yes/no)
． Active device (yes/no)
． Identify the device model
． Technical file or certificate of conformity/declaration
． Equipment Quantity
． unit of use
． clinical scale
． Additional Product Description
． Single use (yes/no)
． Maximum number of reuses
． Does it need to be sterilized?
． Contains latex (yes/no)
． CMR/endocrine disruptor
． Serious Warnings or Contraindications
． Medical Device Nomenclature (CND) codes, etc.
3. Certificates and Notified Bodies
．Product category certificate: EU type inspection certificate, EU technical file certificate, EU product verification certificate.
．Quality certificate: EU quality management system certificate, EU quality assurance certificate, EU production quality assurance certificate.
4. Clinical investigation and performance study (in development)
5. Vigilance and post-market surveillance (in development)
6. Market surveillance (under development)
In Germany, the first time a medical device is placed on the German market must be registered with the competent authority of the corresponding federal state for free sale. Applications are informal but must be made in writing.
The application should state or contain:
1. Receiving country
2. If applicable, state the language version required: the free sales voucher is basically in German, the template is designed with two columns, the first column is German and the second column is German, French, Portuguese or Spanish (depending on the applicant) If no language version is specified, a German/English certificate will be issued.
3. Delivery address
4. Product List
． Item or catalog number
． product name
． UDI-DI
． Certificate of a higher-level product notified body
5. Documentation showing product marketability
． Class I: Relevant Declaration of Conformity
． Class II(a), Class II(b), Class III: In addition to the Declaration of Conformity, a copy of the Notified Body’s Declaration of Conformity is required.
Labels and Instructions for Use:
1. Each product must be accompanied by all safety and performance information necessary for safe use, identification of the product, manufacturer or authorized representative.
2. National language requirements must be taken into account with regard to labels and instructions for use in German, and instructions for use in technical documentation should be in each relevant national language.
3. The label should state that the product is a “medical device”.
4. The information provided by the manufacturer shall be in internationally recognized symbols.
5. It is recommended to check the translation, the manufacturer is liable for personal injury to the patient or others due to incorrect or misleading translation.
【參考連結】
https://www.dimdi.de/dynamic/de/medizinprodukte/institutionen/landesbehoerden-inverkehrbringen/
HLF-TW-55
請問在德國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：
Biorius
https://biorius.com/
TÜV
HLF-TW-60
What documents are required when importing approved medical devices into Germany? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
It is necessary to register in the EU and obtain a local sales certificate for sales.
In Germany, the first time a medical device is placed on the German market must be registered with the competent authority of the corresponding federal state for free sale. Applications are informal but must be made in writing.
The application should state or contain:
1. Receiving country
2. If applicable, state the language version required: the free sales voucher is basically in German, the template is designed with two columns, the first column is German and the second column is German, French, Portuguese or Spanish (depending on the applicant) If no language version is specified, a German/English certificate will be issued.
3. Delivery address
4. Product List
． Item or catalog number
． product name
． UDI-DI
． Certificate of a higher-level product notified body
5. Documentation showing product marketability
． Class I: Relevant Declaration of Conformity
． Class II(a), Class II(b), Class III: In addition to the Declaration of Conformity, a copy of the Notified Body’s Declaration of Conformity is required.
Products bearing the CE label can be sold freely in all European Economic Community (EEC) member states without the need for product testing in other countries.
Goods manufactured outside the EU must have a full customs declaration before they can be freely sold on the EU market.
Businesses and individuals wishing to trade must use the Economic Operator Registration and Identification Number (EORI) as an identification number in all customs procedures.
The EORI number is an EU-wide operator identification number that replaces the German customs number.
In Germany, EORI numbers are assigned by the Master Data Management Office of the General Directorate of Customs in Dresden ( GZD – DO Dresden – Stammdatenmanagement ).
1. Head Office Name/Company Name
2. Date of incorporation (dd/mm/yyyy)
3. Registration Information
4. Region
5. Contact information
． Email address
． Phone number
6. Company address
． Nation
． Zip code
． Place
． Street
． Area
． Address Supplement
7. Tax information
． Applicant’s IRS name
． Tax ID (yes/no)
8. Contacts
． Full name
． Phone number, fax number, email
． Street, house number
． Country name, country postal code, address
． Tax ID
． Financial representative
． Location, date
． Signature: Legally binding signature and company seal
． Telephone number
【參考連結】
https://www.dimdi.de/dynamic/de/medizinprodukte/institutionen/landesbehoerden-inverkehrbringen/
HLF-TW-70
德國醫療器材審核機構，需要附上的實驗室檢驗資料有哪些? 網頁？
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
【參考連結】
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 equipment, 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 equipment 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 equipment 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).
【參考連結】
https://europa.eu/youreurope/business/product-requirements/labels-markings/ce-marking/index_en.htm
HLF-TW-75
德國醫療器材審核機構，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：
The CE certification of medical devices can only be issued by the designated certification body (within the EU) announced on the EU website.
HLF-TW-77
請問在德國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：
TÜV
MDC
HLF-TW-80
After a foreign subsidiary imports medical devices and entrusts a distributor in Germany 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：
It is necessary to register in the EU and obtain a local sales certificate for sales.
Each economic operator (EU and non-EU manufacturers, authorised representatives, system/package producers and importers) must be registered with EUDAMED as a participant and provide the required information.
When adverse events occur, the following persons are responsible (notification and recall):
1. The person responsible for the first time the device is placed on the market: the manufacturer.
2. If the manufacturer does not have a registered place of business in the European Economic Area and has appointed an authorised representative, the authorised representative is responsible.
3. If the medical device is imported into the European Economic Area by the importer without an authorized representative, the importer is the responsible person.
4. If the equipment is operated or used in a professional or commercial framework, the operator or user of the medical device is the responsible person.
5. Distributors, traders, and authorized medical or dental personnel who sell medical devices for personal use to patients or other non-professionals.
6. If the device is offered on the market under the name, registered trade name or registered trademark of a distributor, importer or other natural or legal people, unless the distributor or importer has reached an agreement with the manufacturer, the manufacturer is identified on the label as The manufacturer is also responsible for meeting the requirements of this regulation for the manufacturer, otherwise the trademark registrant shall bear the obligations due to the manufacturer.
【參考連結】
https://www.dimdi.de/dynamic/de/medizinprodukte/institutionen/landesbehoerden-inverkehrbringen/
HLF-TW-85
請問在德國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：
Langner Law
Gerstberger
Mills-Reeve
Contact Us
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Email: fra4ww@evershinecpa.com
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Ms. Anna Wang, Speak German English and Chinese.
skype: burlinna
or
For investment structure relevant to multi-national tax planning and Financial & Legal Due Diligence for M&A (Merge and Acquisition), send an email to HQ4fra@evershinecpa.com
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