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
For manufacturers based outside the EU, appointing an Authorised Representative for medical devices is an important part of accessing the
Software as a medical device (SaMD) has to meet the same technical documentation obligations as any other device under
A medical device regulatory strategy sets out, before development gets far, which rules apply to a product, which market approvals
A medical device quality system has to do more than document procedures. It needs to give an organisation a controlled
An overview of the first episode of NEN’s podcast on AI in healthcare AI keeps turning up across everyday care,
On 17 June 2026, the European Commission published the reference of EN ISO 15223-1:2021/A1:2025 in the Official Journal of the
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