The shift from Directive 98/79/EC to Regulation (EU) 2017/746, the In Vitro Diagnostic Regulation, changed the route to IVD CE
Manufacturers have been able to register in EUDAMED, the European database on medical devices, since December 2020 for the Actor
Using the EUDAMED UDI/Devices module became mandatory on 28 May 2026. This follows the Commission Decision (EU) 2025/2371, which formally
FDA 21 CFR Part 820 is now the Quality Management System Regulation (QMSR). The final rule was published in the
The Medical Device Regulation (EU) 2017/745 (MDR) has applied since 26 May 2021, yet software manufacturers are still working through
We are pleased to welcome Eva Kurilova-Sahin to the MedQAIR team. Eva brings a background in medicine, clinical science, radiology,
Post market surveillance (PMS) for medical devices is the system a manufacturer uses to collect and analyse data on its
The EU declaration of conformity is usually the shortest document in a medical device file, and it is often the
When Regulation (EU) 2017/745 (MDR) started to apply on 26 May 2021, it brought in Rule 11, a classification rule
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