Services
Javitech offers a comprehensive range of services as a European Authorized Representative. A European Authorized Representative (EAR) acts as a liaison between non-EU manufacturers and EU regulatory authorities to ensure that products comply with European Union regulations. This is particularly relevant for sectors such as medical devices, electronics, cosmetics, and other regulated products.
Non-EU manufacturers must appoint an EAR if they want to sell products within the EU market. This is mandatory for medical devices under the Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746), as well as for other products requiring a CE mark. The EAR’s name and address must appear on product labels or packaging, making them a visible point of contact for both authorities and customers within the EU.
Ensure that products meet the relevant EU directives and regulations (e.g., CE marking requirements). Keep up-to-date with any regulatory changes that may affect the manufacturer’s products.
Serve as the primary contact point for EU authorities and customers in case of product issues, audits, or recalls. Respond to requests from regulatory authorities on behalf of the manufacturer.
Maintain and store the product’s technical documentation, such as the Declaration of Conformity (DoC), technical files, and risk assessments. Ensure that this documentation is accessible for inspection by EU authorities for at least 10 years after the product has been placed on the market.
Assist in reporting incidents, especially for medical devices, in compliance with EU vigilance requirements. Support post-market surveillance by helping manufacturers collect feedback and manage any product-related issues.
Verify that the product’s labeling and instructions for use comply with EU requirements, including language and safety warnings.
Facilitate product recalls or corrective actions when necessary to ensure the product’s safety and regulatory compliance within the EU.
Services for Medical Devices
Medical Devices
For medical devices, we help non-EU manufacturers comply with the EU's Medical Device Regulation (MDR) (2017/745) or In Vitro Diagnostic Medical Device Regulation (IVDR) (2017/746).
All non-EU manufacturers placing medical devices or in vitro diagnostic medical devices on the EU market are required to appoint an EU Authorized Representative (EU AR) to ensure compliance with EU regulations. This service is mandatory for non-EU medical device manufacturers to sell their products in the EU.
National registration is required in the EU to ensure regulatory oversight, traceability, and market surveillance of medical devices being placed on the market. The EU Authorized Representative (EU AR) plays a crucial role in facilitating national registration for medical devices within the European Union (EU). Acting on behalf of non-EU manufacturers, Javitech ensures compliance with national and EU-level regulatory requirements. We provide accurate and prompt services, particularly for national registrations with Germany's BfArM or Italy's NSIS.
Although EUDAMED registration is not yet mandatory, manufacturers are strongly encouraged to register as actors and to register their medical devices. We review and approve actor requests for non-EU manufacturers to obtain an SRN, assist with product registration, and support vigilance and reporting activities for serious incidents once the EUDAMED modules are fully implemented.
Free Sales Certificate (FSC) is crucial for exporting medical devices outside the European Union and demonstrates compliance with EU regulations. Javitech liaises with German Competent Authorities to submit FSC applications and ensures all necessary documentation, such as CE marking certificates and Declarations of Conformity, is complete and compliant. We represent the manufacturer throughout the process, and facilitate the timely issuance of the certificate.
We provide critical services in reviewing the technical documentation of medical devices to ensure compliance with the EU Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR). We assess the completeness and accuracy of documents such as the Declaration of Conformity, risk management files, clinical evaluations, and labeling to confirm alignment with regulatory requirements. This review helps manufacturers address potential gaps and achieve seamless market entry in the EU.
We provide comprehensive and reliable consulting services on topics that manufacturers may inquire about, including the preparation of technical documentation, changes to European regulations, the transition to MDR/IVDR, legacy products, IFU content, and incident management. These services are offered in collaboration with WISE COMPANY Inc., a trusted Korean partner that has been in partnership with us since 2015.
Services for Other Products
Cosmetics
As an EU AR, Javitech provides essential services for non-EU manufacturers of cosmetic products to ensure compliance with the EU Cosmetics Regulation (EC) No. 1223/2009. We act as the Responsible Person (RP) within the EU, overseeing product registration in the Cosmetic Products Notification Portal (CPNP) and ensuring the Product Information File (PIF) is complete and compliant. Additionally, we review labeling, safety assessments, and formulations to confirm adherence to EU standards and serve as the point of contact for EU regulatory authorities and market surveillance.
Personal Protective Equipment
We provide crucial services for non-EU manufacturers of personal protective equipment (PPE) to ensure compliance with EU PPE Regulation (EU) 2016/425. We act as the liaison between the manufacturer and EU authorities, technical documentation review, and ensuring that the product meets safety and performance requirements. Additionally, we serve as the point of contact for EU market surveillance authorities.
Toys
Non-EU manufacturers of toys need an EU Authorized Representative (EU AR) to comply with the EU Toy Safety Directive (2009/48/EC) and legally sell toys in the European Union. Javitech helps ensure the toys meet safety requirements, verifies that the necessary technical documentation is in place, serves as the point of contact for EU authorities.
Electronics
Several EU regulations govern electronics, including the EMC Directive for electromagnetic compatibility, the Low Voltage Directive for electrical safety, the Radio Equipment Directive for wireless devices, and the WEEE Directive for electronic waste management. Javitech ensures compliance with EU regulations by verifying technical documentation, acting as a liaison with authorities.
Marine Equipment
Like other products for which an EU AR is required, marine equipment also needs an EU AR to comply with the EU regulation, the Marine Equipment Directive (MED) 2014/90/EU. Javitech helps ensure that marine equipment meets safety and performance standards, assists with the preparation and verification of technical documentation, ensure product conformity, and act as a liaison between the manufacturer and EU authorities ensuring that marine equipment remains compliant throughout its lifecycle in the EU market.
Machinery
Non-EU manufacturers need an EU Authorized Representative to comply with the EU Machinery Directive (2006/42/EC) and legally sell machinery in the European market. Javitech acts as the manufacturer's legal representative in the EU, helping with CE marking, technical documentation, and ensuring compliance with EU safety standards. We also serve as the point of contact for EU authorities, support post-market surveillance, and assist with reporting incidents or defects.
