Knowledgeable EU Authorised Representative for Effective Medical Device Compliance
MedQAIR can be your knowledgeable EU MDR Regulation representative with its long-term European CE expertise, enabling you with more core competency focus.
EU Authorised Representative for Efficient Compliance to Changing Regulations
All non-European based Manufacturers of medical devices, in-vitro diagnostic medical devices and Artificial Intelligence solutions must appoint a competent EU Authorised Representative for marketing their products throughout the European Union.
MedQAIR can act as your qualified and competent EU MDR Regulation expert who will represent your company towards the European authorities and specifically act as a liaison. We help you navigate the intricate medical device regulation (MDR), in-vitro diagnostic medical device regulation (IVDR) and the upcoming AI Act landscape without trouble.
Our holistic approach ensures that your product adheres to all EU medical device regulations and artificial intelligence regulation regarding safety, labelling, and other requirements.
Make us your EU Authorised Representative and achieve regulatory compliance for your medical device portfolio.
EU Authorised Representative Proactive Compliance & Regulatory Services
Are you facing regulatory and commercial challenges for your medical devices in Europe? Join hands with MedQAIR for expert EU MDR Regulation to comply with all regulatory criteria that apply to your MDs, IVDs and AI System solutions. As your European Authorised Representative, we provide full-fledged and personalised regulatory compliance solutions for your medical devices.
We are renowned EU medical device regulation specialists who can manage your product registration compliance and tackle regulatory challenges. We use stringent MDR and IVDR compliance methodologies and seasoned guidance to make this possible. Choose our product-centric medical devices and Artificial Intelligence compliance approach from MedQAIR for exponential growth.
Choose MedQAIR as your European Authorised Representative for industry-defining navigation that assures MDR/IVDR/AI Act compliance.
MedQAIR - For Optimised EU Medical Device Regulation & Risk Management
Appoint MedQAIR as your EU Authorised Representative and get high-quality and professional medical device regulation services. We assist you in cultivating long-term relationships across the European market and authorities to bring safer products while maintaining compliance, irrespective of device uniqueness or its high-risk factor. Our prompt, trusted approach and diverse regulatory expertise allow proactive resolution of potential vulnerabilities. With us, you never have to face any MDR compliance procedure independently.
We Accomplish the Following for Your EU MDR Regulation & Compliance:
- Keep the technical documentation or declaration of conformity accessible for evaluation upon the request from authorities
- As your EU Authorised Representative, we validate the accurate labelling of medical devices and IVDs
- Assist you with monitoring and understanding your reporting requirements in compliance with EU medical device regulations and the AI Act
- Provide a proactive response in the event of medical device or AI incidents associated with your medical device(s) or AI systems
- Be a point of contact for you, the national Competent Authorities, and Notified Bodies
- Ensure that the device labelling complies with the MDR/IVDR compliance norms and standards
- Registration of your products with the relevant office in accordance with the regulatory norms
- Notify the manufacturer of any complaints
Talk to MedQAIR, the trusted EU Authorised Representative for resourceful planning and streamlining of regulatory approval processes.
Frequently Asked Questions About EU Authorised Representative
What happens if I don't designate a European Authorised Representative?
It is against the law to sell products to EU consumers without an approved EU Authorised Representative. Breaching this legal requirement can lead to many implications for your company. Each EU member state will be capable of issuing penalties for breaching the medical device and IVD regulation, under the AI Act the penalties can reach up to 35 million Euro or 7% of the total annual turnover.
Which products require the services of an EU MDR Regulation expert?
Medical devices that are subject to regulation as per MDR, IVDR, and the AI Act require a European Authorised Representative.
Is it the same for manufacturers of in-vitro diagnostic medical devices (IVDs)?
Non-EU based Manufacturers of IVDs should also obtain an EU Authorised Representative.
Article 11 of Regulation 2017/746 shows that the main requirements are identical. There are some differences based on the device’s specifics.
Does the Authorised Representative's name appear on my product?
Yes, everybody who uses your product should know who your Authorised Representative is.
Can a Competent Authority inspect my Authorised Representative?
Yes, under the MDR and IVDR and similarly under the AI Act, manufacturers are obliged to disclose the Authorised Representative within the labelling materials (e.g. product label and or IFU). A Competent Authority can inspect an Authorised Representative at any time to ensure that they understand their job and execute their functions per the applicable legislation, have direct access to client documentation, and have systems in place to meet their obligations as an Authorised Representative.
