Import & Export Requirements for Used Medical Equipment in Europe

Country	Tariffs	Licensing/permits	Regulations	Customs procedures	Miscellaneous notes
Europe
Albania	- 0% to 15% - Used medical equipment from the EU may benefit from exemption from customs duties.	- An import license is required - Used medical equipment must be registered with the National Centre of Drugs and Medical Equipment before importation.	- The import of used medical equipment is subject to sanitary and technical regulations set by the Albanian authorities, aligned with EU regulations. - The importer must ensure the quality and safety of the equipment, with the appropriate certificates of analysis and origin required for customs clearance.	- A customs declaration must be filed with supporting documentation (e.g., invoices, certificates, etc.). - Customs authorities may conduct inspections to ensure compliance with import regulations and health standards. - Required documents include: Certificate of Origin, Certificate of Quality, Certificate of Analysis, Invoice, and Transportation Documents (CMR, BL, AWB)	A description of the sanitary characteristics of the equipment is required to ensure safety standards are met.
Austria	Usually 0%	May need to be registered with the austrian medical device registry.	- Used and refurbished devices must meet the same safety, performance, and labeling standards as new devices. - CE mark	- Commercial Invoices, Packing Lists, and Certificates of Conformity (CoC). - EORI number is required
Belarus	Determined by harmonized system (hs) codes and subject to the same tariffs as general ear99 items.	- License Exception MED allows the export, reexport, and in - Country transfer of EAR99 medical devices (low - Tech medical products) to Russia, Belarus, and the occupied regions of Ukraine.	- Military end users in Belarus are prohibited from receiving certain medical items - The Consolidated Screening List (CSL) should be consulted to verify that parties involved in the transaction are not subject to U.S. sanctions or license requirements. - Parts, components, accessories, and attachments must be exclusively used for EAR99 medical devices - Exporters must implement due diligence measures and maintain documentation for five years - Used equipment must be included in the State Register of Medical Devices in Belarus to be allowed for use. - Used medical devices must undergo health and safety checks by the Ministry of Health or other regulatory bodies - Used equipment must be certified for safety and functionality before importation.	- All used medical equipment must be declared to Belarusian Customs upon entry. - The declaration should include the import license, invoice, packing list, and certificate of conformity. Pre - License Checks (PLC) or Post - Shipment Verifications (PSV) may be required for shipments to ensure that the items are used as stated in the license application. - Exporters must provide detailed technical descriptions and end user information - Used medical devices may be subject to a physical inspection by customs officers to verify compliance with health and safety standards. conformity assessment - Certification of refurbishment might be required	- U.S. sanctions on Belarus have tightened since the invasion of Ukraine, with restrictions on various goods, including medical equipment. - Exporters should be aware of the "red flags" or warning signs that may indicate potential violations of EAR - Used medical devices from the EU may require the CE marking to comply with EAEU standards. - If from non - EU countries, additional local certification may be necessary.
Belgium	- No specific tariffs for used medical equipment; treated the same as new medical equipment. - Import duties depend on the tariff classification of the product.under the Harmonized System (HS) code. VAT :21%	- Refurbished devices must be authorized by the Federal Agency for Medicines and Health Products (FAMHP) before they can be used in Belgium. - CE mark required for all devices (new and refurbished). - In some cases, depending on the nature of the equipment, a special import license or permit may be required from Belgian health authorities (e.g., Federal Agency for Medicines and Health Products, FAGG/AFMPS).	- Used and refurbished devices must meet the same safety, performance, and labeling standards as new devices. - Must comply with EU Medical Device Regulation (MDR 2017/745) and In - Vitro Diagnostic Medical Device Regulation (IVDR 2017/746). - If the used medical equipment is being imported from outside the EU, a Responsible Person (based in the EU) must be appointed	- Standard EU customs procedures apply for used medical equipment. the importer must submit a customs declaration to Belgian Customs (Service Public Federal Finances). - This declaration must include information on the equipment's HS code, value, and country of origin. - Products must be classified according to the Combined Nomenclature (CN) for import into the EU.	Liability concerns may make public health institutions cautious about purchasing used or refurbished devices.
Bosnia and Herzegovina	- VAT of 17% - Could be eligible for tariff exemptions under the BiH Customs Tariff Law if imported for specific humanitarian, medical, or educational purposes.	Must include a customs declaration in bosnian, serbian, or croatian with relevant documents (e.g., invoice, shipping docs, quality control certificates)	Testing and certification required for used medical equipment	- Bill of Lading, Insurance Certificate, etc. Conformity assessment - CE marking or equivalent
Bulgaria	20% VAT is levied on customs clearance	Bulgarian decree required	Ce mark must meet eu certification requirements and comply with bulgarian drug agency standards.	- Invoice, certificate of origin, transport documents - Economic Operators Registration and Identification (EORI) number.	Maintenance contracts must be secured for used medical equipment.
Croatia	Usually 0%	Quality control certificates may be needed	- CE mark must comply with EU CE certification requirements. - Labels must be in Croatian and meet local product standards. - Used medical equipment classified under the EU classification system.	- Single Administrative Document (SAD) for customs clearance - Commercial Invoice, Packing List, and Certificates of Origin. - Certificates of Conformity (CoC) - An EORI number is needed to import goods into the EU.	Goods move freely among member states of eu
Cyprus	- Up to 30% import tax may apply, depending on the classification of the used medical equipment. CE - Marked devices from the EU may enter tariff free.	Importers must notify the cyprus medical devices authority (cymda) about the used medical equipment being placed in the market.	- Must comply with EU medical device regulations, ensuring devices meet safety standards. - Labeling must be in Greek for layperson use devices. - English is accepted for professional use devices.	- Commercial Invoice, Packing List, and Datasheets. - Compliance with customs regulations is mandatory, including obtaining an EORI number if importing from a third country.
Czech Republic	Usually 0%	No special import licenses for medical devices.	- CE mark Safety and labeling standards must be met. - Used medical equipment classified under the EU classification system.	- Commercial Invoice, Bill of Lading, Shipper's Export Declaration - Declaration of Conformity - An EORI number is needed to import goods into the EU.
Denmark	Usually 0%	No special import licenses for medical devices.	- CE mark Compliance with EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). - Safety and labeling standards must be met. - Used medical equipment classified under the EU classification system.	- Importers must use the Single Administrative Document (SAD) for customs declarations. - Economic Operator Registration and Identification (EORI) number is required - Customs IT systems and the Union Customs Code (UCC) are implemented with full transition by 2025. - Country of origin might be marked	Labels must be in danish or a language with minimal spelling differences (norwegian or swedish).
Estonia	Usually 0%	No special import licenses for medical devices.	- CE mark Safety and labeling standards must be met. - Used medical equipment classified under the EU classification system. Non - EU manufacturers must appoint an Authorized Representative within the EU.	- Commercial Invoice, Bill of Lading, Shipper's Export Declaration - Declaration of Conformity (CoC) - An EORI number is needed to import goods into the EU.	- Labeling must be in Estonian. - Used equipment, must be registered or notified for market access
Finland	Usually 0%	No special import licenses for medical devices.	- Devices must be registered with Valvira (National Supervisory Authority for Welfare and Health) CE mark - Compliance with EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). - Safety and labeling standards must be met. - Used medical equipment classified under the EU classification system. Non - EU manufacturers must appoint an Authorized Representative within the EU.	- Importers must use the Single Administrative Document (SAD) for customs declarations - Commercial Invoice, Bill of Lading, Shipper's Export Declaration - Declaration of Conformity - An EORI number is needed to import goods into the EU. - Valuation declaration for items exceeding EUR 5,045.64, must be provided	- All used medical equipment must have clear labeling in Finnish and Swedish, including product name, manufacturer, and contents. - Serious incidents involving the device must be reported within 10 days
France	Usually 0%	No special import licenses for medical devices.	- CE mark Compliance with EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). - Safety and labeling standards must be met. - Used medical equipment classified under the EU classification system.	- Importers must use the Single Administrative Document (SAD) for customs declarations - Commercial Invoice, Bill of Lading, Shipper's Export Declaration - Declaration of Conformity - An EORI number is needed to import goods into the EU.	All labeling must be in french
Germany	Usually 0%	No special import licenses for medical devices.	- CE mark Compliance with EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). - Must comply with RoHS, WEEE. - Safety and labeling standards must be met. - Used medical equipment classified under the EU classification system.	- Importers must use the Single Administrative Document (SAD) for customs declarations - Commercial Invoice, Bill of Lading, Shipper's Export Declaration - Declaration of Conformity - An EORI number is needed to import goods into the EU.
Greece	Usually 0%	No special import licenses for medical devices.	- CE mark Compliance with EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). - Safety and labeling standards must be met. - Used medical equipment classified under the EU classification system.	- Commercial Invoice, Bill of Lading, Shipper's Export Declaration - Declaration of Conformity - An EORI number is needed to import goods into the EU.
Hungary	Usually 0%	- No special import licenses for medical devices - License might be required by Hungarian Trade Licensing Office	- CE mark Compliance with EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). - ISO 13485 certification required for QMS. - Safety and labeling standards must be met. - Used medical equipment classified under the EU classification system. Non - EU manufacturers must appoint an Authorized Representative within the EU.	- Commercial Invoice, Bill of Lading, Shipper's Export Declaration - Declaration of Conformity - An EORI number is needed to import goods into the EU.
Iceland	Iceland follows the harmonized system (hs); duties are applied based on product classification, with no tariffs on many consumer goods	No special import licenses for medical devices.	- CE mark Safety and labeling standards must be met. - Used medical equipment classified under the EU classification system.	- Commercial Invoice, Bill of Lading, Shipper's Export Declaration must be submitted within 3 months of arrival - Declaration of Conformity - An EORI number is needed to import goods into the EU.	Relabeling may be required to meet icelandic language
Ireland (Republic of)	Usually 0%	No special import licenses for medical devices.	- CE mark Compliance with EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). - Safety and labeling standards must be met. - Used medical equipment classified under the EU classification system.	- Importers must submit a Summary Declaration for used medical equipment. - Importers must use the Single Administrative Document (SAD) for customs declarations - Commercial Invoice, Bill of Lading, Shipper's Export Declaration - Declaration of Conformity - An EORI number is needed to import goods into the EU.
Italy	Usually 0%	No special import licenses for medical devices.	- CE mark Compliance with EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). - Safety and labeling standards must be met. - Used medical equipment classified under the EU classification system.	- Importers must use the Single Administrative Document (SAD) for customs declarations - Commercial Invoice, Bill of Lading, Shipper's Export Declaration - Declaration of Conformity - An EORI number is needed to import goods into the EU.	- Medical devices are subject to vigilance by the Italian Ministry of Health (USMAF SASN) - Labeling in Italian
Latvia	Usually 0%	No special import licenses for medical devices.	- CE mark Compliance with EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). - Safety and labeling standards must be met. - Used medical equipment classified under the EU classification system.	- Importers must use the Single Administrative Document (SAD) for customs declarations - Commercial Invoice, Bill of Lading, Shipper's Export Declaration - Declaration of Conformity - An EORI number is needed to import goods into the EU.	Labeling in latvian
Liechtenstein	Usually 0%	Notification required for first time import	- CE mark Compliance with EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). - Safety and labeling standards must be met. - Used medical equipment classified under the EU classification system. - Used medical equipment that does not meet Swiss market requirements must be documented and registered with the Office of Public Health	- Goods enter Liechtenstein through Swiss border - Importers must use the Single Administrative Document (SAD) for customs declarations - Commercial Invoice, Bill of Lading, Shipper's Export Declaration - Declaration of Conformity - An EORI number is needed to import goods into the EU.	Labeling in german required
Lithuania	Usually 0%	All medical devices (including used) require registration with the competent authority.	- CE mark Compliance with EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). - Safety and labeling standards must be met. - Used medical equipment classified under the EU classification system.	- Importers must use the Single Administrative Document (SAD) for customs declarations - Commercial Invoice, Bill of Lading, Shipper's Export Declaration CIPL, Datasheets - Declaration of Conformity - An EORI number is needed to import goods into the EU.	Labeling must be in lithuanian
Luxembourg	Usually 0%	No special import licenses for medical devices.	- CE mark Compliance with EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). - Safety and labeling standards must be met. - Used medical equipment classified under the EU classification system. Non - EU manufacturers must appoint an Authorized Representative within the EU	- Importers must use the Single Administrative Document (SAD) for customs declarations - Commercial Invoice, Bill of Lading, Shipper's Export Declaration - Declaration of Conformity - An EORI number is needed to import goods into the EU.	Documentation must be submitted in luxembourgish.
Malta	Usually 0%	No special import licenses for medical devices.	- CE mark Compliance with EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). - Safety and labeling standards must be met. - Used medical equipment classified under the EU classification system. Non - EU manufacturers must appoint an Authorized Representative within the EU - UDI assigned, devices registered in EUDAMED,	- Importers must use the Single Administrative Document (SAD) for customs declarations - Commercial Invoice, Bill of Lading, Shipper's Export Declaration - Declaration of Conformity - An EORI number is needed to import goods into the EU.	Labeling in maltese/english
Moldova (Republic of)	- It depends on the HS code (Harmonized System Code) of the equipment. - For medical equipment, many items may be eligible for reduced or zero customs duties under certain conditions	Import permits may be required for medical equipment	- CE mark Compliance with EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). - Safety and labeling standards must be met.	- Customs declaration must be submitted electronically, - Importers must use the Single Administrative Document (SAD) for customs declarations - Commercial Invoice, Bill of Lading, Shipper's Export Declaration	- Labels in Romanian with specific product details - Deferred payment for customs duties available from 2024
Monaco	Usually 0%	Import permit from the ministry of health may be required for some medical products	- Customs clearance in Monaco is processed through French customs CE mark - Compliance with EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). - Safety and labeling standards must be met. - Used medical equipment classified under the EU classification system. - Health department authorization if applicable	- Importers must use the Single Administrative Document (SAD) for customs declarations - Commercial Invoice, Bill of Lading, Shipper's Export Declaration - Declaration of Conformity - An EORI number is needed to import goods into the EU.
Montenegro	Usually 0%	Import permits may be needed, particularly for medical devices with health related risks	- Customs duties are assessed based on the contract price CE mark - Compliance with EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). - Safety and labeling standards must be met. - Used medical equipment classified under the EU classification system.	- Importers must use the Single Administrative Document (SAD) for customs declarations - Commercial Invoice, Bill of Lading, Shipper's Export Declaration - Declaration of Conformity - An EORI number is needed to import goods into the EU.
Netherlands	Usually 0%	No special import licenses for medical devices.	- Customs duties are assessed based on the contract price CE mark - Compliance with EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). - Safety and labeling standards must be met. - Used medical equipment classified under the EU classification system.	- Importers must use the Single Administrative Document (SAD) for customs declarations - Commercial Invoice, Bill of Lading, Shipper's Export Declaration - Declaration of Conformity - An EORI number is needed to import goods into the EU.
North (Republic of)	Usually 0%	No special import licenses for medical devices.	- Customs duties are assessed based on the contract price CE mark - Compliance with EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). - Safety and labeling standards must be met. - Used medical equipment classified under the EU classification system. - The EC Conformity certificate is required and valid until its expiration;	- Registration process for used medical devices takes about 90 days Importers must use the - Single Administrative Document (SAD) for customs declarations. - Commercial Invoice, Bill of Lading, Shipper's Export Declaration - Declaration of Conformity - An EORI number is needed to import goods into the EU.
Norway	0% to 10% depending on the harmonized system code classification.	No special import licenses for medical devices.	- CE mark Compliance with EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). - Unique Device Identification (UDI) - Safety and labeling standards must be met. - Used medical equipment classified under the EU classification system. - Reprocessing of single - Use devices is prohibited	- Importers must use the Single Administrative Document (SAD) for customs declarations - Commercial Invoice, Bill of Lading, Shipper's Export Declaration - Declaration of Conformity - An EORI number is needed to import goods into the EU.	All relevant documentation (conformity, safety notifications) must be in english or norwegian
Poland	Usually 0%	No special import licenses for medical devices.	- CE mark Compliance with EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). - Safety and labeling standards must be met. - Used medical equipment classified under the EU classification system - Devices must be registered with the Office for Registration of Medicinal Products if required.	- Declaration to Customs using CN (Customs Nomenclature) classification - Importers must use the Single Administrative Document (SAD) for customs declarations - Commercial Invoice, Bill of Lading, Shipper's Export Declaration - Declaration of Conformity - An EORI number is needed to import goods into the EU.
Portugal	Usually 0%	No special import licenses for medical devices.	- CE mark Compliance with EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746); enforced by INFARMED in Portugal. - Safety and labeling standards must be met. - Used medical equipment classified under the EU classification system.	- Importers must use the Single Administrative Document (SAD) for customs declarations - Commercial Invoice, Bill of Lading, Shipper's Export Declaration - Declaration of Conformity - An EORI number is needed to import goods into the EU.
Romania	Usually 0%	The importer may need to notify or register the device with anmdmr (national agency for medicines and medical devices of romania), especially if it is a refurbished or used item.	- CE mark Compliance with EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). - Safety and labeling standards must be met. - Used medical equipment classified under the EU classification system.	- Importers must use the Single Administrative Document (SAD) for customs declarations - Commercial Invoice, Bill of Lading, Shipper's Export Declaration - Declaration of Conformity - An EORI number is needed to import goods into the EU.
Russia (Russian Federation)	Usually 0%	- License Exception MED allows the export, reexport, and in - Country transfer of EAR99 medical devices (low - Tech medical products) to Russia, Belarus, and the occupied regions of Ukraine.	- Items must be for civilian use; military or government use prohibited - Due diligence required to ensure the equipment is for civilian medical facilities providing direct patient care Military end - Users (Russian and Belarusian Ministries of Defense) are restricted	- Applications evaluated by U.S. agencies to assess risk of diversion Requires End - Use/User Statements Specific Harmonized System (HS) Codes and item descriptions required for efficient review
Serbia	0% to 10% depending on the harmonized system code classification	- Import licenses required for non - Registered medical devices;	- CE mark Must meet Serbian safety and technical regulations, including Serbian conformity mark for non - EU good Safety and labeling standards must be met. - Used medical equipment classified under the EU classification system.	- Goods must be declared via the Unique Customs Document; use of NCTS for EU based imports. - Commercial Invoice, Bill of Lading, Shipper's Export Declaration - Declaration of Conformity - An EORI number is needed to import goods into the EU.
Slovak Republic	Usually 0%	Required certification from the slovak institute for drug control (sukl) for used medical equipment, based on european certification	- CE mark Compliance with the Union Customs Code (UCC) - Compliance with EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). - Safety and labeling standards must be met. - Used medical equipment classified under the EU classification system.	- Importers must use the Single Administrative Document (SAD) for customs declarations - Commercial Invoice, Bill of Lading, Shipper's Export Declaration - Declaration of Conformity - An EORI number is needed to import goods into the EU.
Slovenia	Usually 0%	No special import licenses for medical devices	- CE mark Compliance with EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). - Safety and labeling standards must be met. - Used medical equipment classified under the EU classification system.	- Importers must use the Single Administrative Document (SAD) for customs declarations - Commercial Invoice, Bill of Lading, Shipper's Export Declaration - Declaration of Conformity - An EORI number is needed to import goods into the EU.	Local slovene language for equipment details
Spain	Usually 0%	No special import licenses for medical devices	- CE mark Registration in the EUDAMED system is necessary - Compliance with EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). - Safety and labeling standards must be met. - Used medical equipment classified under the EU classification system. Non - EU manufacturers must appoint an Authorized Representative within the EU - No local testing required	- Importers must use the Single Administrative Document (SAD) for customs declarations - Commercial Invoice, Bill of Lading, Shipper's Export Declaration - Declaration of Conformity - An EORI number is needed to import goods into the EU.
Sweden	Usually 0%	No special import licenses for medical devices	- CE mark Compliance with EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). - Safety and labeling standards must be met. - Used medical equipment classified under the EU classification system. - Equipment must meet Swedish Medical Products Agency (Läkemedelsverket) standards for medical devices.	- Importers must use the Single Administrative Document (SAD) for customs declarations - Commercial Invoice, Bill of Lading, Shipper's Export Declaration - Declaration of Conformity - An EORI number is needed to import goods into the EU.	Ce marked devices can be placed on the market without additional local permits, but they must be registered in the eu's eudamed database.
Switzerland	May be subject to import duties based on the harmonized system (hs) code for medical devices	No special import licenses for medical devices	- CE mark Compliance with Swiss MedDO (for medical devices) and IvDO (for in - Vitro diagnostics) Safety and labeling standards must be met. - Used medical equipment classified under the EU classification system. - The healthcare provider must verify compliance with Swissmedic and ensure the device does not enter the market for resale. - Used devices may face additional scrutiny on customs clearance	- Commercial Invoice, Bill of Lading, Shipper's Export Declaration - Declaration of Conformity	- Used devices cannot be supplied to patients unless they are implants - Devices must be appropriately labeled in the Swiss national languages (German, French, and Italian)
Ukraine	Average tariff: 4.8%	Import license required	- Registration with the State Expert Center of the Ministry of Health is required for medical devices. - Meet Ukrainian safety and labeling standards. - Importers must be registered at Customs as foreign trade entities. - Safety and labeling standards must be met. - Used medical equipment classified under the EU classification system.	- Importers must use the Single Administrative Document (SAD) for customs declarations - Commercial Invoice, Bill of Lading, Shipper's Export Declaration - Export Declaration or T1 - Declaration of Conformity might be required based on device type Data Sheets. - Photos. An EORI number is needed to import goods into the EU.	Ukrainian language labeling
United Kingdom	Usually 0%	No special import licenses for medical devices	- Must comply with UKCA marking requirements. - Compliance with EU Medical Device Regulation (MDR 2017/745) - Safety and labeling standards must be met.	- Commercial Invoice, Bill of Lading, Shipper's Export Declaration - Declaration of Conformity - Used medical devices may require inspection and testing for safety compliance
Vatican City	Usually 0%	No special import licenses for medical devices	- CE mark Compliance with EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). - Safety and labeling standards must be met. - Used medical equipment classified under the EU classification system.	- Importers must use the Single Administrative Document (SAD) for customs declarations - Commercial Invoice, Bill of Lading, Shipper's Export Declaration - Declaration of Conformity - An EORI number is needed to import goods into the EU.	Imports are regulated by italy under the eu system

Europe

Albania

https://www.tradeclub.stanbicbank.com/portal/en/market-potential/albania/customs

https://www.trade.gov/country-commercial-guides/albania-trade-agreements

Austria

https://www.trade.gov/country-commercial-guides/austria-import-tariffs

https://www.basg.gv.at/en/consumers/medizinprodukte#:~:text=In%20Austria%2C%20as%20in%20other,in%20relation%20to%20the%20benefits.

https://www.regdesk.co/an-overview-of-medical-device-regulations-in-austria/#:~:text=Due%20to%20Austria’s%20membership%20as,but%20it%20is%20not%20required.

https://www.mouseandbear.com/map/austria.htm#:~:text=Consider%20the%20end%2Duse%20and,not%20proceed%20with%20the%20import.

Belarus

https://sanctionsnews.bakermckenzie.com/us-commerce-department-issues-license-exception-eliminating-licensing-requirements-for-many-medical-devices-to-be-sent-to-russia-belarus-crimea-the-donetsk-peoples-republic-and-the-luhansk-peopl/

https://www.wilmerhale.com/insights/client-alerts/20240503-bis-adds-new-license-exception-for-medical-devices-to-russia-belarus-and-occupied-regions-of-ukraine

Belgium

https://www.trade.gov/country-commercial-guides/eu-trade-agreements

https://www.privacyshield.gov/ps/article?id=Belgium-Medical-Devices

Bosnia

https://www.trade.gov/country-commercial-guides/bosnia-and-herzegovina-trade-agreements

Bulgaria

https://iamers.org/2015/05/pre-owned-medical-importation-by-country/

https://www.mouseandbear.com/map/bulgaria.htm

Croatia

https://www.mouseandbear.com/map/croatia-.htm

https://iamers.org/2015/05/pre-owned-medical-importation-by-country/#:~:text=Croatia%3A%20Used%20and%20Refurbished%20Medical,products%20with%20CE%20within%20EU.

Czech republic

https://www.trade.gov/country-commercial-guides/czech-republic-trade-standards

https://arazygroup.com/ivd-medical-device-registration-czech-republic/

https://celnisprava.gov.cz/en/dalsi-kompetence/informace-pro-fyzicke-osoby/Pages/import-export-and-transit-of-habit-forming-substances-and-medicaments.aspx

https://www.mouseandbear.com/map/czech-republic-.htm#view-covered-country

Denmark

https://iamers.org/2015/05/pre-owned-medical-importation-by-country/#:~:text=Denmark%3A%20In%20general%2C%20there%20are,strong%20market%20for%20such%20equipment.

https://www.trade.gov/country-commercial-guides/denmark-customs-regulations

https://www.mouseandbear.com/map/denmark.htm#view-covered-country

Estonia

https://www.riigiteataja.ee/en/eli/524052016001/consolide

https://www.regdesk.co/the-lowdown-on-medical-device-regulations-in-estonia/

https://www.mouseandbear.com/map/estonia-.htm

https://www.trade.gov/country-commercial-guides/estonia-licensing-requirements-professional-services

Finland

https://www.mouseandbear.com/map/finland-.htm

https://www.regdesk.co/an-overview-of-medical-device-regulations-in-finland/

https://www.trade.gov/country-commercial-guides/finland-customs-regulations

France

https://iamers.org/2015/05/pre-owned-medical-importation-by-country/#:~:text=France%3A%20Importation%20of%20used%20and,strong%20market%20for%20such%20equipment.

https://www.trade.gov/country-commercial-guides/france-customs-regulations

Germany

https://iamers.org/2015/05/pre-owned-medical-importation-by-country/

https://www.trade.gov/healthcare-resource-guide-germany

Greece

https://www.lexology.com/panoramic/tool/workareas/report/pharma-and-medical-device-regulation/chapter/greece

https://www.trade.gov/country-commercial-guides/greece-trade-barriers?navcard=3907

https://www.mouseandbear.com/map/greece.htm

Hungary

https://www.trade.gov/country-commercial-guides/hungary-customs-regulations

https://www.regdesk.co/hungary-reg/

https://iamers.org/2015/05/pre-owned-medical-importation-by-country/#:~:text=Hungary%3A%20Used%20medical%20equipment%20can,demand%20for%20used%20medical%20devices.

Iceland

https://www.privacyshield.gov/ps/article?id=Iceland-Prohibited-Restricted-Imports

https://www.skatturinn.is/english/companies/customs-matters/importing-to-iceland/

https://www.trade.gov/country-commercial-guides/iceland-customs-regulations

Ireland

https://www.revenue.ie/ga/contact-us/index.aspx

https://www.hse.ie/eng/services/publications/pp/medical-device-regulations.html

https://www.trade.gov/country-commercial-guides/ireland-licensing-requirements-professional-services

Italy

https://www.mouseandbear.com/map/italy-.htm

https://www.trade.gov/country-commercial-guides/italy-customs-regulations

https://www.direnzo.biz/it/en/custom-medical-device/

Latvia

https://www.direnzo.biz/it/en/custom-medical-device/

https://www.vid.gov.lv/en/customs-clearance-goods-and-state-border-crossing-under-priority-treatment

https://www.trade.gov/country-commercial-guides/latvia-customs-regulations

Liechtenstein

https://companyformationliechtenstein.com/imports-and-exports-in-liechtenstein/

https://www.mouseandbear.com/map/liechtenstein.htm

https://www.mouseandbear.com/map/liechtenstein.htm\

Lithuania

http://www.thema-med.com/en/medical-device-registration-in-lithuania/

https://www.mouseandbear.com/map/lithuania-.htm

https://www.trade.gov/country-commercial-guides/lithuania-customs-regulations

Luxembourg

https://www.mouseandbear.com/map/luxembourg-.htm

https://logistics.public.lu/en/formalities-procedures/type-goods/health-products/medical-devices.html

Malta

file:///C:/Users/resident/Downloads/Fact%20Sheet%20for%20Imp%20&%20Dis.pdf

https://www.trade.gov/country-commercial-guides/malta-customs-regulations

Moldova

https://www.trade.gov/country-commercial-guides/moldova-customs-regulations

Monaco

https://www.certvalue.com/ce-certification-in-monaco/

https://morganshipping.com/country/monaco

https://www.mouseandbear.com/map/monaco.htm

Montenegro

https://www.trade.gov/country-commercial-guides/montenegro-licensing-requirements-professional-services

Netherlands

https://www.trade.gov/country-commercial-guides/netherlands-import-requirements-and-documentation

https://www.privacyshield.gov/ps/article?id=Netherlands-Import-Requirements-and-Documentation

North Macedonia

https://www.trade.gov/country-commercial-guides/north-macedonia-trade-agreements

Norway

https://www.trade.gov/country-commercial-guides/norway-trade-agreements

https://www.norden.org/en/info-norden/customs-regulations-norway

https://www.dmp.no/en/medical-devices/sale-import-and-distribution/the-different-roles-of-economic-operators/general-obligations-for-importers-and-distributors-of-medical-devices#Oversikt-over-de-ulike-rollene-for-markedsdeltakere-179053

Poland

https://www.trade.gov/country-commercial-guides/poland-trade-agreements

https://insightplus.bakermckenzie.com/bm/healthcare-life-sciences/poland-new-medical-device-obligations-take-effect-1-july-2023

https://iamers.org/2015/05/pre-owned-medical-importation-by-country/#:~:text=Poland%3A%20There%20are%20no%20restrictions,buying%20pattern%20has%20been%20identified.

Portugal

https://www.trade.gov/country-commercial-guides/portugal-customs-regulations

https://www.garrigues.com/en_GB/new/portugal-implements-eu-medical-device-regulation

https://www.regdesk.co/portu-reg/#Online_registration

Romania

https://www.trade.gov/country-commercial-guides/romania-customs-regulations-and-contact-information

https://bnt.eu/legal-news/new-regulations-in-the-field-of-medical-devices/

https://iamers.org/2015/05/pre-owned-medical-importation-by-country/

Russia

https://www.trade.gov/country-commercial-guides/russia-us-export-controls-russia-belarus

https://www.wilmerhale.com/insights/client-alerts/20240503-bis-adds-new-license-exception-for-medical-devices-to-russia-belarus-and-occupied-regions-of-ukraine

https://www.tuvsud.com/en-my/-/media/global/pdf-files/brochures-and-infosheets/med-info-download-center/tuvsud-importing-medical-devices-into-the-russian-federation.pdf

https://iamers.org/2015/05/pre-owned-medical-importation-by-country/#:~:text=Russia:%20Importation%20is%20allowed%2C%20but,for%20sale%20through%20government%20tenders.

Serbia

https://www.trade.gov/country-commercial-guides/serbia-customs-regulations

https://www.mouseandbear.com/map/serbia.htm\

https://iamers.org/2015/05/pre-owned-medical-importation-by-country/#:~:text=Serbia%3A%20Importation%20of%20used%20and,certification%20requirements%20and%20CE%20mark.

Slovakia

https://www.trade.gov/country-commercial-guides/slovakia-customs-regulations

https://iamers.org/2015/05/pre-owned-medical-importation-by-country/#:~:text=Slovak%20Republic%3A%20Importation%20of%20used,certification%20requirements%20and%20CE%20mark.

Slovenia

https://www.trade.gov/country-commercial-guides/slovenia-trade-agreements

Spain

https://www.trade.gov/country-commercial-guides/spain-trade-agreements

https://arazygroup.com/ivd-medical-device-registration-spain/?utm_term=&utm_campaign=CEO+Reach&utm_source=adwords&utm_medium=ppc&hsa_acc=7211744863&hsa_cam=21176099513&hsa_grp=&hsa_ad=&hsa_src=x&hsa_tgt=&hsa_kw=&hsa_mt=&hsa_net=adwords&hsa_ver=3&gad_source=1&gclid=EAIaIQobChMI4aeDhaTfiQMVmSBECB2MhC_AEAMYAiAAEgImbfD_BwE

https://iamers.org/2015/05/pre-owned-medical-importation-by-country/#:~:text=Spain%3A%20Importation%20of%20used%20and,strong%20market%20for%20such%20equipment.

Sweden

https://www.trade.gov/country-commercial-guides/sweden-customs-regulations

https://iamers.org/2015/05/pre-owned-medical-importation-by-country/#:~:text=Sweden%3A%20Importation%20of%20used%20and,no%20demand%20for%20used%20equipment.

https://www.norden.org/en/info-norden/customs-regulations-sweden

Switzerland

https://www.trade.gov/country-commercial-guides/switzerland-trade-agreements

https://decomplix.com/swiss-medical-device-importers/#:~:text=If%20the%20importer%20starts%20placing,2022%2C%20per%20IvDO%20Article%2088.

https://www.emergobyul.com/news/medical-device-direct-imports-users-switzerland#:~:text=Swissmedic%20has%20taken%20a%20pragmatic,also%20be%20considered%20the%20importer.

Ukraine

https://www.trade.gov/country-commercial-guides/ukraine-import-tariffs

https://medenvoyglobal.com/services-we-offer/importer-services/uk-importer-services/#:~:text=If%20the%20product%20has%20CE,as%20the%20Importer%20with%20MHRA.

https://www.mouseandbear.com/blog/a-guide-to-importing-goods-into-ukraine.htm

United Kingdom

https://www.trade.gov/country-commercial-guides/united-kingdom-customs-regulations

https://iamers.org/2015/05/pre-owned-medical-importation-by-country/

Vatican City (same laws as Italy)

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