Your experts for global compliance of medical devices
We offer representative services in various international markets. Our services include legal representation, regulatory support and market entry assistance to help companies gain access to new markets.
Our market knowledge and global network ensure that our clients are compliant in the respective regions and can position their products successfully.
PROCESS OPTIMIZATION
We analyze and optimize your processes to ensure that they always meet global compliance requirements. In doing so, we integrate targeted measures into your processes to increase their efficiency and ensure regulatory conformity in the long term.
Risk avoidance
We carefully analyze all potential risks that may arise in the context of the regulatory requirements and market approval of your medical devices. By precisely identifying these risks, we develop proactive strategies to effectively minimize them.
SAFETY
We have many years of expertise in the regulatory requirements in various countries and ensure that your medical device meets all relevant standards and regulations.
We have helped these customers achieve compliance
EU authorized representative
Responsible person
Data Protection Officer
EU Authorized Representative
Why is a European Authorized Representative necessary?
A European Authorized Representative is necessary to ensure that companies that sell their products in the European Union and are not based in the EU comply with the legal requirements and regulatory provisions of the EU. Particularly in the area of medical devices, in vitro diagnostics and other regulated products, the authorized representative plays a central role in communication with the competent authorities, ensures proper registration and documentation and ensures compliance with the relevant standards. He also helps to minimize legal risks and ensure the company's conformity on the European market.
he EU regulations, in particular the Medical Device Regulation (MDR) 2017/745, require non-EU manufacturers of medical devices to appoint a European Authorized Representative. This regulation ensures that non-EU companies are subject to the same high standards and regulatory obligations as manufacturers based in the EU.
A European Authorized Representative acts as a local point of contact for the EU regulatory authorities. This local presence is crucial for efficient communication with the EU authorities and facilitates all necessary interactions, including inspections, inquiries and reporting.
The appointment of a European Authorized Representative is a crucial prerequisite for market access. It demonstrates to regulatory authorities and customers in the EU that the non-EU manufacturer is committed to full compliance with EU standards and regulations.
The European Authorized Representative is responsible for maintaining the technical documentation and ensures that it is accessible to the European authorities at any time upon request. This documentation contains the proof of conformity with the relevant regulations, which is crucial for the legality of the product on the EU market.
The European Authorized Representatives support vigilance and post-market surveillance by assisting in the reporting of incidents or serious risks related to the medical device to the competent EU authorities.
The European Authorized Representative plays an essential role in facilitating communication between the non-EU manufacturer, EU regulatory authorities, healthcare professionals and patients. This includes answering questions about the safety and use of the product.
The European Authorized Representative also assumes some legal liability for the non-EU manufacturer's products in the EU. He acts on behalf of the manufacturer in various legal and compliance-related matters within the EU legal system.
Why is MEDAGENT the ideal partner for you?
Appointing MEDAGENT as your European Authorized Representative offers you numerous advantages on the way to successfully launching your medical device on the European market. Our many years of experience and extensive expertise in regulatory matters in the field of medical devices make us a leading partner in the industry.
At MEDAGENT, we have a long history and in-depth expertise in regulatory matters, especially in the field of medical devices. This expertise is critical to navigating the complex and ever-evolving EU regulatory landscape and ensuring that your product meets all required compliance standards efficiently and reliably.
We are proud of our highly qualified team who are always on hand to provide you with expertise. Our employees are not only proven experts in their field, but are also actively committed to staying informed of the latest regulatory developments. This commitment ensures that your product successfully passes through the approval process smoothly and based on the latest regulatory knowledge.
With more than 200 audits conducted each year, we demonstrate our meticulous approach and attention to detail. This extensive audit experience gives us a unique perspective on compliance and quality assurance. In this way, we guarantee that your medical device is optimally prepared for the strict requirements of the EU regulatory authorities.
With MEDAGENT as your European Authorized Representative, you benefit from our in-depth understanding of EU regulations to ensure a smooth market entry. Our expertise ensures an efficient registration process, minimizes the risk of compliance issues and shortens the time to market for your medical device.
We are more than just a service provider - we are your partner for sustainable success. Our commitment extends beyond initial approval and includes ongoing support and advice on post-market surveillance and adapting to regulatory changes.
MEDAGENT combines extensive regulatory experience, knowledgeable staff, an impressive audit history and an unwavering commitment to client success. This makes us the ideal choice for your European Authorized Representative. With us, you not only gain a service provider, but a strategic partner who is actively committed to ensuring that your medical device is successful on the European market.
Person Responsible for Regulatory Compliance
Your partner for regulatory compliance on the European market.
In the dynamic and constantly evolving world of medical device regulation in the European Union, the role of the Person Responsible for Regulatory Compliance (PRRC) plays an indispensable key role. It ensures that all regulatory requirements are met and the highest standards of product safety and quality are guaranteed. At MEDAGENT, we offer a bespoke PRRC service to ensure that your products not only comply with the latest EU regulations, but are also continuously adapted to changing regulatory requirements. With our expertise and experience at your side, you can rest assured that your products will always be legally compliant and ready for success on the European market.
Always on the safe side with our PRRC services:
Product safety monitoring: Implementation of post-market surveillance systems to report and respond to incidents or risks.
Reporting incidents and problems: Responsibility for reporting serious incidents or risks associated with a medical device or in vitro diagnostic medical device.
Training and education: Ensure that all employees involved in the manufacture and distribution of medical devices are informed about current regulatory requirements.
Our comprehensive support for compliance with EU regulations for medical devices and in vitro diagnostic medical devices, including the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR), ensures that your product fully complies with all regulatory requirements. We offer customized solutions to help you efficiently navigate the complex and ever-evolving regulations. Our expertise ensures that your products always meet the highest standards, from approval to market surveillance, minimizing legal risks and securing market access in the EU.
The careful maintenance of technical documentation is a central component of our PRRC services. We ensure that your technical documentation is complete, up-to-date and compliant with EU regulations at all times. This includes the proper recording, updating and archiving of all relevant documents. Through our precise documentation maintenance, we not only ensure compliance with the Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR), but also that your product is accessible and transparently verifiable at any time at the request of the competent authorities.
Why is MEDAGENT the ideal PRRC partner for you?
Our experts combine over 25 years of experience with in-depth expertise to provide you with first-class regulatory support. Through continuous training and close monitoring of changing EU legislation, we ensure that your products always meet the latest requirements. In this way, we meet the requirements of Regulation (EU) 2017/745 Article 15 and ensure a legally compliant and future-proof market strategy.
Whether you are an innovative start-up or an established company - we develop customized solutions that are precisely tailored to your individual requirements. With our expertise and practical experience, we guide you through the complex regulatory processes and ensure that your products reach the market smoothly and in compliance.
Together, we ensure seamless compliance and smooth market access in the EU. Our PRRC service ensures that your products comply with current regulatory requirements at all times. Contact us for more information or to take advantage of our services - we will reliably guide you through every step of the regulatory process.
Data Protection Officer
EU data protection redefined - your partner for comprehensive security.
In the digital age, the protection of personal data is of paramount importance. MEDAGENT's GDPR Officer Service ensures that your company fully complies with all the strict requirements of the European Union's General Data Protection Regulation (GDPR) and the German Federal Data Protection Act (BDSG), thereby maintaining the highest security and compliance standards.
Data protection that offers more - customized solutions for your company:
Our experts ensure full compliance of your data processing activities with the strict requirements of the General Data Protection Regulation (GDPR). With in-depth expertise and a proactive approach, we ensure that all aspects of your data processing are legally compliant at all times. From data collection to storage and processing, we guide you through the entire compliance process to ensure the highest standards of data protection and minimize potential risks. In addition, we offer continuous monitoring of your data protection practices through regular data protection audits to ensure that your company always complies with current legal requirements and responds quickly to any changes.
Our team of experts conducts a thorough and systematic analysis of your business processes in order to precisely identify and assess potential data protection risks. Based on the findings of this detailed analysis, we develop tailor-made, innovative strategies to effectively minimize risks.
In today's digitalized business world, the protection of sensitive information is of paramount importance. Data protection is not just a legal obligation, but a collaborative task that requires the commitment of every single employee. Our training program aims to establish and maintain a robust data protection culture in your company.
We offer a wide range of specialized training courses tailored to the specific needs and challenges of your company:
- Basic training: Teaching essential data protection principles for all levels of staff
- Department-specific workshops: Focused training for particularly sensitive areas such as HR, IT or customer service
- Management seminars: Strategic training on integrating data protection into management decisions
- Practice-oriented simulations: Realistic exercises for dealing with data protection incidents
Our training courses use the latest pedagogical approaches to convey learning content effectively and sustainably:
- Interactive e-learning modules
- Gamification elements to increase motivation to learn
- Virtual scenarios for immersive learning experiences
Why choose MEDAGENT for your data protection?
Our data protection experts have extensive expertise in data protection law and continuously monitor the latest developments in the GDPR. Through regular training and further education, they are always up to date with the latest legal requirements. In this way, we guarantee legally compliant and practice-oriented advice that optimally supports your company in complying with all data protection regulations.
Every company is unique - and that's exactly how we design our services. With a deep understanding of your individual requirements, we develop customized solutions that are perfectly tailored to your business processes. Our aim is to offer you tailor-made, efficient and future-proof support that meets your specific challenges.
For us, data protection is far more than just a legal obligation - it is an essential component of a trustworthy and sustainable corporate strategy. Effective data protection not only strengthens compliance, but also the trust of your customers and business partners. We help you to use data protection as a competitive advantage and to future-proof your company.
Data protection is now an indispensable part of modern business life. To find out more about our GDPR Officer Service and MEDAGENT LEARN or to take advantage of these services, contact us. Our dedicated team is ready to help you ensure and maintain the highest data protection standards and lead your business into a data protection compliant future.
UK Responsible Person
As a UK Responsible Person, we offer our clients a wide range of professional services to ensure compliance with the UK MDR 2002 and facilitate market access in the UK. We ensure the availability and compliance of essential documents, including the Declaration of Conformity and Technical Documentation. We also hold copies of all relevant certificates and provide these promptly to the Medicines and Healthcare products Regulatory Agency (MHRA) on request.
In close consultation with our customers, we monitor the application of suitable conformity assessment procedures and act as a central point of contact for the MHRA. We coordinate the exchange of information between manufacturers and authorities to ensure efficient communication. This comprehensive support allows our clients to focus on their core competencies while we responsibly manage the regulatory requirements in the UK.
MEDAGENT International UK Limited was founded to fulfill these tasks in the best possible way. This specialized unit enables us to perform the role of UK Responsible Person fully and efficiently. With our extensive expertise and dedicated structure, we support medical device manufacturers in meeting regulatory requirements in the UK and ensuring smooth market access.
Simple, fast, successful: MHRA registration in just three steps.
Our structured process for MHRA registration and UK MDR 2002 compliance begins with the provision of customized templates. These specially adapted forms already contain essential information about your company and the medical devices to be registered, which significantly optimizes the registration process.
Our expertise enables the efficient registration of up to 100 product groups (based on GMDN codes) with a maximum of 20,000 items per registration via the MHRA database. The registration fee is £240 per registration.
In accordance with UK MDR 2002 requirements, we ensure that the required technical documentation is available to your UK Responsible Person. We carry out a thorough review of your technical documentation to ensure that it is up to date and complete and provide you with detailed feedback. If necessary, we will also provide you with targeted support in rectifying any shortcomings in your documentation.
Our comprehensive approach not only ensures smooth MHRA registration, but also full compliance with UK MDR 2002 regulations. This enables you to access the UK market safely and efficiently.
While you fill in the templates provided by us, we will also carefully check your documents. Throughout the entire registration process, we will be at your side as a reliable partner and will be happy to answer any questions you may have. We support you in preparing your information optimally for registration and thus ensure a smooth process. Once all templates have been completed and returned to us, your part of the work is complete. We will then thoroughly check the information received and initiate the registration of your products in the MHRA database.
From this point onwards, we take over the entire process as your reliable partner. We submit all relevant information via the MHRA database and are in direct contact with the UK authority to ensure that your registration is processed smoothly and efficiently. After successful submission, we receive feedback from the MHRA within a very short time. With our support, you will be officially registered in the UK in just three steps and can continue to place your products on the UK market safely and without interruption.
Transitional provisions UKCA
According to the latest information, the transition period for CE-marked medical devices has been extended. These may now continue to be placed on the UK market until June 30, 2028 (for general medical devices) or June 30, 2030 (for in vitro diagnostic medical devices) without the need for UKCA marking, provided the CE certificates remain valid.
Brazilian Registration Holder
Navigate safely through Brazil's medical device regulations with us.
For over a decade, MEDAGENT has established itself as a trusted partner for international medical device manufacturers with ambitions in the Brazilian market. In our role as Brazilian Registration Holder since 2012, we offer a comprehensive range of services that go far beyond the mere fulfillment of regulatory requirements. Our experienced team will navigate you safely through Brazil's complex regulatory landscape and support you in efficiently overcoming the many challenges of market entry. With in-depth expertise and many years of experience in the specifics of the Brazilian healthcare sector, we ensure that your medical devices not only meet the strict requirements of ANVISA, but can also be brought to market smoothly. We see ourselves as your strategic partner, enabling you to focus on your core competencies while we navigate the regulatory hurdles and promote your success in the promising Brazilian medical device market
Local expertise, global perspective - your success in Brazil starts here:
The Brazilian Registration Holder (BRH) plays a central role for foreign manufacturers of medical devices who wish to sell their products on the Brazilian market. As the manufacturer's official representative to the Brazilian health authority ANVISA, the BRH performs essential regulatory tasks, including submitting registration applications, maintaining the required documentation and ensuring compliance with local regulations. MEDAGENT offers you this service as a reliable and experienced Brazilian Registration Holder to ensure smooth market access and full compliance with Brazilian health requirements.
We take care of the complete registration of your medical devices with ANVISA, the Brazilian health authority, ensuring that all regulatory requirements are met accurately and on time. Our service includes the preparation, review and submission of the required technical documentation, which is aligned with strict Brazilian regulations and international standards. Our expertise in the Brazilian approval process ensures that your products are efficiently granted market access and fully comply with regulatory requirements.
For specific product classes, we offer support in complying with Brazilian manufacturing practices (B-GMP) and INMETRO certification to ensure that your products meet the highest quality standards. Our service includes conducting audits, detailed reviews of relevant documentation and planning and conducting annual inspections. These measures ensure that your company continuously complies with Brazilian requirements and that your products always have the necessary quality and safety to compete successfully in the market.
Would you like to find out more about our Brazilian Registration Holder Service or take advantage of it? Contact us today. With our expertise and in-depth knowledge of Brazilian regulatory requirements, we can provide you with reliable support on the path to successful market approval for your medical devices in Brazil.
U.S. Agent
Medical products made easy - the path to the US market starts here.
Navigating the complex regulatory requirements of the U.S. is often a significant challenge for medical device manufacturers. With our U.S. Agent Service at MEDAGENT, we offer reliable and competent support to help you navigate this process smoothly and efficiently. We ensure that your medical device meets all required regulations and successfully achieves market access in the USA. From the first step of product registration to final market access - we will guide you through the entire approval process.
Competent, reliable, effective - MEDAGENT as your U.S. agent for success:
Since our founding in 2004, we have established ourselves as a trusted partner for international manufacturers seeking to enter the challenging US market. Our extensive experience includes more than 165 FDA inspections and over 130 FDA registrations per year. In addition, we manage more than 200 listings annually and therefore have in-depth knowledge of the specific requirements and peculiarities that the FDA places on registration and medical device listing. This extensive expertise enables us to offer you a customized and efficient solution for market access in the USA and to ensure that your products easily meet the required regulatory standards.
As your U.S. Agent, we act as the essential link between your company and the FDA to ensure smooth and efficient market access. Our experts handle all communication and correspondence with the FDA and ensure that all regulatory requirements are met accurately and on time. From registering your products to handling inquiries and inspections, we act on your behalf to ensure that your company remains compliant with US regulations at all times and that market access runs smoothly.
Our experts ensure that your products and processes comply with the latest FDA requirements at all times. Through our continuous monitoring and in-depth analysis of the regulations, we ensure that all relevant requirements are always met. We guide you through the entire approval process and ensure that your products not only comply with current FDA requirements, but also remain future-proof. With our expertise, we minimize risks and enable smooth market access in the USA.
Your success is what drives us:
At MEDAGENT, we know that your company's success in the US market depends on a precise and efficient regulatory strategy. Our mission is to ensure seamless compliance and enable you to access the market without barriers. With our many years of expertise, we stand for integrity, professionalism and a cooperative partnership that gives you security and trust.
Would you like to find out more about our U.S. Agent Service or benefit directly from our support? Contact us today - we will accompany you reliably on your way to market success in the USA.
Case studies: Our success stories
30% fewer production errors
Task
A manufacturer of surgical instruments was struggling to reduce the production error rate to an acceptable level. The company found that quality controls were not efficient enough and that internal processes were not optimally coordinated.
Solution
To overcome this challenge, the company approached us to implement a comprehensive quality management system (QMS). We first conducted a thorough analysis of the existing processes to identify weaknesses. Based on these findings, we developed a customized QMS based on international standards such as ISO 13485. We trained the company's employees intensively in the new processes and carried out regular internal audits to ensure compliance with the quality guidelines. In addition, we implemented a real-time monitoring system that enabled production errors to be detected and rectified immediately.
Result
The result was impressive: within a year, the company was able to reduce the production error rate by 30%. The introduction of the new QMS not only led to a significant reduction in errors, but also to an increase in productivity and an improvement in product quality, which had a positive impact on customer satisfaction.
Faster approval due to shorter audit
Task
A medium-sized company specializing in the manufacture of dental implants was faced with the challenge of shortening the time it took to obtain market approval for its products. The audit processes often took several months, which significantly delayed the launch of new products.
Solution
The company commissioned us with the task of optimizing the entire audit process and shortening its duration. We analyzed the existing processes and identified several areas where efficiency improvements could be made. In collaboration with the company, we developed an optimized quality management system that met the requirements of ISO 13485 while taking into account the specific needs of the company. A key component was the introduction of digital tools for documenting and tracking processes, which significantly improved transparency and traceability. We also provided training to ensure that all employees were familiar with the new procedures.
Result
Thanks to these measures, the company was able to reduce the audit duration by 20%. The accelerated market approval enabled the company to react more quickly to market changes and introduce new products promptly. This not only led to a better competitive position, but also to greater satisfaction among customers and business partners.