KEY ASPECTS OF EUROPEAN AUTHORIZED REPRESENTATIVE SERVICES
Representation for Non-EU Manufacturers
We act as your official representative (EC-Rep) within the European Union, a mandatory requirement for non-EU manufacturers under the EU Medical Device Regulation (MDR) (and under the IVDR for in-vitro devices). This fulfills the legal obligation to have an EU-based representative for your device.
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. We continuously monitor regulatory changes to maintain your compliance.
Communication with EU Authorities
We serve as the primary contact point for communications with European regulatory authorities. This includes managing all correspondence and queries from Competent Authorities or Notified Bodies related to your devices.
Documentation and Registration
Our services include managing the necessary documentation to meet EU standards. This involves handling the EU Declaration of Conformity and maintaining the technical documentation for compliance verification by Notified Bodies or authorities. We also assist with required device registrations in databases as needed.
Vigilance and Incident Reporting
We oversee vigilance activities, including incident reporting and field safety corrective actions. In the event of any reportable incident or recall, we ensure timely and proper notification to authorities and help coordinate the response.
Market Surveillance Support
We assist in market surveillance obligations, ensuring your devices continually meet the necessary regulatory and safety standards throughout their lifecycle on the EU market.
Advisory and Consultation
Our team provides expert advice and consultation on regulatory changes and requirements, keeping you informed and prepared for compliance in the dynamic EU regulatory landscape. This proactive guidance helps you adapt to updates in regulations or standards.
WHY CHOOSE MDS FINLAND AS YOUR EUROPEAN AUTHORIZED REPRESENTATIVE?
Expertise in EU Regulations
Our extensive knowledge of EU medical device regulations (MDR and IVDR) ensures that your products meet all necessary requirements for market access. We interpret and apply these regulations effectively on your behalf.
Strategic Representation
We provide strategic representation in the EU as your official EC-Rep, facilitating smoother navigation of the regulatory process. Our local presence and experience help prevent delays and miscommunications with European authorities.
Comprehensive Service
From documentation management to vigilance reporting, we offer a complete range of services covering all aspects of EU regulatory compliance. You gain a single point of contact for managing regulatory obligations in Europe.
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 and remain in full compliance throughout their time on the market.
