Import & Export Requirements for Used Medical Equipment in Europe

Country	Licensing/permits	Regulations	Customs procedures	Miscellaneous notes
Europe
Albania	- Import license 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 compliance.
Austria	- 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	- (U.S.-Only) License Exception MED allows the export, reexport - (U.S.-Only) Country transfer of EAR99 medical devices (low-tech medical products) to Russia, Belarus, and the occupied regions of Ukraine - All medical devices (new or used) must undergo state registration with the Belarus Ministry of Health prior to importation	- 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.-Only) U.S. sanctions on Belarus have tightened since the invasion of Ukraine, with restrictions on various goods, including medical equipment - (U.S.-Only) 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	- 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	- 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	- 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	- 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	- 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	- 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	- 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 may need to be indicated	- Labels must be in Danish or in a language with minimal spelling differences (Norwegian or Swedish).
Estonia	- 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	- 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	- 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	- 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	- 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	- 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	- 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 requirements.
Ireland (Republic of)	- 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	- 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 must be in Italian
Latvia	- 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 must be in Latvian.
Liechtenstein	- 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 must be in German.
Lithuania	- 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	- 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	- 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 must be in Maltese/English.
Moldova (Republic of)	- 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 must be in Romanian with specific product details - Deferred payment for customs duties available from 2024
Monaco	- 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	- 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	- 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)	- 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	- 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	- 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	- 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	- 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)	- (U.S.-Only) 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 - All medical devices - whether new, used, or refurbished - must be registered with Roszdravnadzor, Russia’s Federal Service for Surveillance in Healthcare, before importation - An import permit for registration purposes must be issued by Roszdravnadzor under Order No. 7n (2012)	- 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 - Once registered via EAEU procedures, the device must bear the EAC mark and can be marketed freely across Russia and other EAEU nations	- (U.S.-Only) 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. - Registration certificate; Technical dossier (including test reports, IFU, QMS); Invoice, Packing List, Certificate of Orgin; Test and Safety Certification evidence
Serbia	- 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	- 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	- 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 required for equipment details.
Spain	- 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	- 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	- 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	- Import license required - (U.S.-Only) 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	- 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 and Photos required - An EORI number is needed to import goods into the EU	- Ukrainian language labeling required
United Kingdom	- Equipment registration with the Medicines and Healthcare products Regulatory Agency (MHRA).	- UKCA marking required for most devices - Compliance with EU Medical Device Regulation (MDR 2017/745) - Equipment must be fully re-certified, safe and meet UK MDR 2002	- Commercial Invoice, Bill of Lading, Shipper's Export Declaration and Declaration of Conformity - All equipment must be declared via the UK CDS customs system - Used medical devices may require inspection and testing for safety compliance
Vatican City	- 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)

Click on a Region to see a country’s requirements

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