KEY ASPECTS OF EUROPEAN AUTHORIZED REPRESENTATIVE SERVICES
Representation for Non-EU Manufacturers
We act as your official representative within the European Union, a mandatory requirement for non-EU manufacturers under the EU Medical Device Regulation (MDR).
Regulatory Compliance Assurance
Our team ensures that your medical devices comply with EU regulations, facilitating the CE marking process which is essential for market access in the EU.
Communication with EU Authorities
We serve as the primary contact point for communications with European regulatory authorities, managing all correspondence and queries related to your medical devices.
Documentation and Registration
Our services include managing necessary documentation, ensuring that it meets EU standards. This involves handling the EU Declaration of Conformity and technical documentation for compliance verification by Notified Bodies.
Vigilance and Incident Reporting
We oversee vigilance activities, including incident reporting and field safety corrective actions, ensuring timely and appropriate responses to any safety concerns related to your products.
Market Surveillance Support
We assist in market surveillance activities, ensuring your devices continually meet the necessary regulatory and safety standards throughout their market lifecycle.
Advisory and Consultation
Our team provides expert advice and consultation on regulatory changes and requirements, keeping you informed and prepared for compliance with the dynamic EU regulatory landscape.
WHY CHOOSE MDS FINLAND AS YOUR EUROPEAN AUTHORIZED REPRESENTATIVE?
Expertise in EU Regulations
Our extensive knowledge of EU medical device regulations ensures that your products meet all necessary requirements for market access.
Strategic Representation
We provide strategic representation in the EU, facilitating smoother navigation of the regulatory process.
Comprehensive Service
From documentation management to vigilance reporting, we offer a complete range of services to cover all aspects of EU regulatory compliance.
FACILITATING YOUR ACCESS TO THE EU MARKET
MDS Finland is committed to supporting your efforts to enter and succeed in the European market. By partnering with us for European Authorized Representative services, you benefit from our expertise and comprehensive support, ensuring that your medical devices comply with the stringent regulatory standards of the EU.
