1. Definition & Regulatory Context Definition of Custom-Made Devices (CMDs) Under Article 2(3) of the EU MDR, a custom-made device is defined as any medical device specifically made in accordance...
1. Introduction: What is SaMD? Definition of SaMD Software as a Medical Device (SaMD) refers to software that is intended to perform medical functions without being part of a hardware medical device...
Background: Why PMS & PMCF are Game-Changers under EU MDR Regulatory Evolution: From MDD to MDR Under the previous Medical Device Directive (MDD 93/42/EEC), Post-Market Surveillance (PMS) and...
Background Context The EU Medical Device Regulation (MDR 2017/745) came into force in May 2021 (with transition timelines extended to 2028/2029 in some cases via Regulation (EU) 2023/607). It...
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