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Jul 19, 2022 | Regulatory, News
Medical devices are constantly changing and evolving to meet the needs of patients and healthcare professionals. The Medical Device Coordination Group (MDCG) has released a new guidance document, MDCG 2022-6, Guidance on significant changes regarding the transitional...
Jun 29, 2022 | Regulatory, News
The De Novo classification process is a risk-based approach for classifying novel medical devices that had previously been automatically placed in Class III, the highest United States device classification. On October 4, 2021, the US Food and Drug Administration (FDA)...
Jun 24, 2022 | Regulatory
EUDAMED is one of the key elements of the European Medical Devices Regulation (EU) 2017/745 (MDR) and the In-Vitro Diagnostic Medical Devices Regulations (EU) 2017/746 (IVDR). The European Database for Medical Devices, or EUDAMED, is intended to store and provide...