Latest Blog Posts
Navigating MDR: Fresh Insights and Updates
EUDAMED UDI Registration Checklist for Manufacturers
Using the EUDAMED UDI/Devices module became mandatory on 28 May 2026. This follows the Commission Decision (EU) 2025/2371, which formally declared the first four modules
Meet the Team: Eva Kurilova-Sahin
We are pleased to welcome Eva Kurilova-Sahin to the MedQAIR team. Eva brings a background in medicine, clinical science, radiology, and oncology research, together with
EU AI Act Requirements for AI-Enabled Medical Devices
The regulatory landscape for medical devices is becoming more complex as artificial intelligence becomes part of diagnosis, monitoring, treatment, and clinical decision support. For manufacturers,
Advancements in AI/ML Standards
Summary Artificial intelligence is evolving faster than the regulatory frameworks around it. But that gap is beginning to close, with a growing body of AI
Digital Authorised Representative: A Smarter Approach to Medical Device Compliance
For manufacturers based outside the EU, appointing an Authorised Representative for medical devices is an important part of accessing the European market. But the role
You Can’t Escape CE Marking
Summary An EU Authorised Representative plays a critical role for medical device and in vitro diagnostic manufacturers established outside the European Union. Under the MDR
SaMD technical documentation checklist for MDR submission
Software as a medical device (SaMD) has to meet the same technical documentation obligations as any other device under Regulation (EU) 2017/745, and Annexes I,
Role of the Authorised Representative
Summary An EU Authorised Representative plays a critical role for medical device and in vitro diagnostic manufacturers established outside the European Union. Under the MDR
Medical Device Regulatory Strategy: How to Build a Clear Path to Market
A medical device regulatory strategy sets out, before development gets far, which rules apply to a product, which market approvals are needed, and what evidence
