WHY DO I NEED A EUROPEAN REPRESENTATIVE
A non-EU company is required to assign a European Representative for several key reasons, primarily related to compliance with EU regulations:
EU regulations, particularly the Medical Device Regulation (MDR) 2017/745, mandate that non-EU manufacturers of medical devices appoint a European Representative. This requirement ensures that non-EU companies adhere to the same standards and regulatory obligations as EU-based companies.
A European Representative acts as a local point of contact within the EU for regulatory authorities. This local presence is crucial for effective communication with EU regulatory bodies, facilitating any necessary interactions, including inspections, queries, and reporting.
Having a European Representative is essentially a prerequisite for market access. It signifies to the regulatory bodies and customers within the EU that the non-EU manufacturer is committed to complying with EU standards and regulations.
The European Representative is responsible for maintaining the technical documentation and ensuring it is readily available to the European authorities upon request. This documentation includes evidence of conformity with relevant regulations, which is critical for the product’s legality in the EU market.
European Representatives are tasked with assisting in the vigilance and post-market surveillance activities. They help in reporting any incidents or serious risks associated with the medical device to the appropriate EU authorities.
The European Representative plays a vital role in facilitating communication between the non-EU manufacturer and the EU regulatory authorities, healthcare professionals, and patients. This includes providing responses to any queries regarding the device’s safety and use.
The European Representative also assumes a certain degree of legal liability for the non-EU manufacturer’s products in the EU. They act on behalf of the manufacturer in many legal and compliance matters within the EU jurisdiction.
In summary, appointing a European Representative is not only a regulatory requirement for non-EU companies wishing to market their medical devices in the EU, but it also provides essential support in navigating the EU’s regulatory environment, maintaining compliance, and ensuring effective communication and legal representation within the EU.
Why MEDAGENT?
Assigning MEDAGENT as your European Representative opens the door to a myriad of advantages for your medical device's journey into the European market. Our unmatched experience and profound know-how in regulatory affairs related to medical devices set us apart as an industry leader.
Extensive Experience and Expertise
At MEDAGENT, we boast a rich history and deep-rooted expertise in regulatory affairs specific to medical devices. This expertise is invaluable in navigating the complex and ever-evolving EU regulatory landscape, ensuring that your product meets all the necessary compliance standards efficiently and effectively.
Dedicated and Knowledgeable Staff
We pride ourselves on our highly skilled team, readily available to support your needs. Our staff are not only experts in their field but also committed to staying abreast of the latest regulatory developments. This dedication ensures that your product’s journey through the approval process is smooth and informed by the most current regulatory insights.
Proven Track Record in Audits
Our experience extends to conducting over 200 audits per year, a testament to our meticulous approach and attention to detail. This extensive audit experience equips us with a unique perspective on compliance and quality assurance, ensuring that your medical device is prepared to meet the stringent standards set by EU regulators.
Seamless Compliance and Market Entry
By choosing MEDAGENT as your European Representative, you leverage our comprehensive understanding of EU regulations to facilitate a seamless market entry. Our expertise translates into a smoother approval process, reduced risk of compliance issues, and faster time-to-market for your medical device.
Continuous Support and Guidance
We are more than just a service provider; we are partners in your success. Our commitment to your project extends beyond initial approvals, offering ongoing support and advice to navigate post-market surveillance requirements and any regulatory changes that may arise.
MEDAGENT’s blend of extensive regulatory experience, knowledgeable staff, impressive audit history, and unwavering commitment to client success makes us an ideal choice for your European Representative. With us, you gain not only a service provider but a strategic partner dedicated to ensuring your medical device thrives in the European market.
Contact EU Representative
Contact us to find out more about the MEDAGENT service and the EU representative.