Our Digital AR services enable streamlined, fast, continuous, and secure sharing and review of technical documentation. They
support easy UDI management and include built-in EUDAMED connectivity for both medical devices and IVDs.
As a fully digital authorised representative (AR) for medical devices, we provide you with access to our complete medical device compliance platform. Manufacturers can securely upload technical documentation, including labelling materials, initiate verification flows for medical devices to the Authorised Representative (both for Basic UDI-DIs and UDI-DIs), and automate EUDAMED registrations through the same system.
Once the Authorised Representative agreement is signed, simply upload your documentation. Our experts review and
communicate the approval through our software, allowing your device to go live quickly in supported markets.
We understand that regulatory reviews can delay innovation. That’s why our process is designed for speed and traceability:
Class I devices
limited review of Declaration of Conformity (DoC) and key changes.
Class IIa / IIb devices
review per Article 11 requirements (DoC and Technical Documentation presence) within 72 hours.
Class III / IIb (implantable) devices
review limited to Article 11 requirements, and changes that impact safety and or performance of the medical devices.
To ensure proper change management procedures on the end of the manufacturer, MedQAIR conducts a yearly compliance review, where we digitally review your change management processes and post-market surveillance data at any time convenient to you. This can be extended to an official internal audit if desired, which you can use in your quality management system.
This workflow is ideal for software and AI-based devices, where frequent updates require agile compliance oversight, reducing recurring review costs.
By using our MDIS platform as part of your Authorised Representative service, you can also:
Share technical documentation and labelling securely with importers and distributors.
Provide 24/7 access to authorised stakeholders.
Ensure each party only views the documentation relevant to their role and region.
This approach supports seamless collaboration and audit-ready traceability across your entire device lifecycle.
With MedQAIR, every verification and approval step is traceable and documented.
Our digital AR for medical devices services ensure transparent workflows that demonstrate compliance for each device and economic operator. All contracts, verification steps, and mandatory documentation are securely stored in one location, providing clear, auditable records at any time.
MedQAIR can act as your fully digital Authorised Representative and digital importer across the European Union, the United Kingdom, and Switzerland. We are continuously expanding our network.
If you are seeking partnership opportunities in new regions, we welcome collaboration with local regulatory experts and representatives.
We understand that security and confidentiality are fundamental to regulatory trust.Therefore, we have implemented the ISO/IEC 27001 standard within our organization to support the implementation of strong technical and organizational measures to keep your documentation safe,secure, and confidential. It further supports data integrity and the availability of the platform.
See how MedQAIR simplifies medical device documentation management, compliance workflow automation,
and transparent oversight for manufacturers and PRRCs.
Meet The Team
Find answers to common questions about our services, compliance processes, and how we can assist your business.
A Digital Authorised Representative (Digital AR) combines regulatory expertise with a secure, cloud-based compliance platform. Unlike traditional ARs that rely on emails and manual document exchange, MedQAIR provides continuous access, verification, and approval of Technical Documentation through a single digital system. This ensures full traceability, faster reviews, and simplified communication between authorised representatives and the connected manufacturers, PRRCs, importers, and distributors.
MedQAIR uses a software platform (‘MDIS’), which includes a dedicated PRRC role to demonstrate compliance. Each PRRC, whether internal or external, can receive assigned tasks, review documentation, and document approvals in a traceable manner. Every action is timestamped, creating a clear audit trail that aligns with MDR and IVDR requirements.
The medical device compliance platform centralizes all technical documentation, CE certificates, and (localised) labelling materials. Manufacturers and Economic Operators or medical device partners can securely upload, review, and share documentation, ensuring that only authorized users can access relevant sections as granularly shared by the manufacturer. This structure replaces fragmented file sharing with a unified, compliant medical device documentation management system.
Yes. MedQAIR’s compliance workflow automation allows manufacturers to initiate verification flows for all Basic UDI-DIs and subsequent UDI-DIs, manage approvals, and push registration data directly into EUDAMED. This reduces repetitive manual checks, ensures consistency, and speeds up the device approval process while maintaining regulatory accuracy across regions.
MedQAIR serves as a digital Authorised Representative for medical devices across the European Union, the United Kingdom, and Switzerland (and other countries to come).
Our digital authorised representative platform is designed to adapt to country-specific regulatory frameworks and will soon extend coverage to additional global regions in cooperation with local compliance partners.
Cookies help us improve your experience on our website. By using our site, you consent to the use of cookies as described in this policy.
