MedQAIR

A Digital Approach to Authorised Representation:

Under the EU MDR 2017/745 and IVDR 2017/746, Authorised Representatives carry shared responsibility for ensuring that devices placed on the market comply with regulatory requirements. Under the EU AI Act, non-EU providers of high-risk AI (Art. 22) and GPAI models (Art. 54) must appoint ARs for compliance facilitation, without MDR/IVDR's product liability.

Traditional AR arrangements often rely on fragmented document exchange, manual approvals, and limited visibility between manufacturers and their ARs.

MedQAIR’s Digital AR service replaces these manual processes with a controlled, auditable environment. Manufacturers can securely upload Basic UDI-DIs, UDI-DIs, and supporting documentation, initiate automated review workflows, and ensure that their AR has continuous access to verified, up-to-date technical files.

The integrated workflow enables faster verification, transparent approvals, and structured documentation trails that remain accessible for inspection at any time.


Secure, Traceable, and Audit-Ready:

All documentation managed within the Digital AR environment is hosted on MedQAIR’s Medical Device Information System (MDIS): a platform certified under ISO/IEC 27001 for information security management.

The system ensures data confidentiality, integrity, and availability across all connected parties, while providing complete traceability of each review and approval step.

“Authorised Representation today requires both regulatory competence and secure digital infrastructure,” said Leon Doorn, Co-Founder and CEO of MedQAIR. “By combining our consulting expertise with a secure cloud platform, we make compliance oversight faster, traceable, and dependable for every manufacturer we represent.”

“Digital Authorised Representation is not just about moving documents online. It requires controlled workflows, secure access, and reliable traceability for every stakeholder involved,” said Ivo Flipse, Co-Founder and CTO of MedQAIR. “Our platform gives manufacturers and PRRCs a structured environment where every update, review, and approval is documented and available when needed.”


Designed for Modern Devices and Global Collaboration:

The Digital AR service supports manufacturers of both hardware and software-based medical devices, including AI-enabled systems that require frequent updates and agile compliance management.

Through MDIS, MedQAIR enables secure sharing of technical documentation, labelling, and post-market evidence with importers and distributors, ensuring each Economic Operator has access only to the data relevant to their regulatory duties.

The service currently covers the European Union, the United Kingdom, and Switzerland, with plans to extend availability through partnerships with local representatives in additional regions.


About MedQAIR:

MedQAIR provides regulatory, quality, information security and compliance support for medical devices, IVDs, and AI-enabled health technologies. The company offers PRRC services, Authorised Representative support, and a secure documentation platform (MDIS) that enables traceable information flow and EUDAMED registration for Economic Operators. Services cover both pre-market and post-market obligations and support traditional, software-based, and AI-driven devices.

MedQAIR operates under a certified ISO/IEC 27001 Information Security Management System and supports manufacturers worldwide in meeting MDR, IVDR, and other global compliance requirements.

Press Contact:
MedQAIR Services B.V. ,
Matrix ONE, Science Park, Amsterdam,
Noord-Holland 1098 XH, NL
CoC: 94675473

???? info@medqair.com
???? www.medqair.com