Using the EUDAMED UDI/Devices module became mandatory on 28 May 2026. This follows the Commission Decision (EU) 2025/2371, which formally
We are pleased to welcome Eva Kurilova-Sahin to the MedQAIR team. Eva brings a background in medicine, clinical science, radiology,
The regulatory landscape for medical devices is becoming more complex as artificial intelligence becomes part of diagnosis, monitoring, treatment, and
Summary Artificial intelligence is evolving faster than the regulatory frameworks around it. But that gap is beginning to close, with
For manufacturers based outside the EU, appointing an Authorised Representative for medical devices is an important part of accessing the
Summary An EU Authorised Representative plays a critical role for medical device and in vitro diagnostic manufacturers established outside the
Software as a medical device (SaMD) has to meet the same technical documentation obligations as any other device under
Summary An EU Authorised Representative plays a critical role for medical device and in vitro diagnostic manufacturers established outside the
A medical device regulatory strategy sets out, before development gets far, which rules apply to a product, which market approvals
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