The new article highlights the aspects related to the content of the clinical investigation report, discusses additional considerations associated with the transitional period, and explains the status of a legal representative.
RegDesk Regulatory Roundup
The new article describes in detail the applicable classification approach and highlights the key considerations associated thereto.
The new article highlights the aspects related to the timelines associated with the clinical investigations, the way they should be calculated, and other relevant matters.
The article provides an overview of the provisions of a guidance document and highlights the key points to be taken into consideration by medical device manufacturers (software developers).
Medical devices are an integral part of healthcare, and their safety and efficacy are critical to ensure patient well-being. In 2017, the European Parliament and Council adopted the new Medical Devices Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) to...
The article highlights the key points associated with the substantial changes to performance studies in the context of the new regulatory framework. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European Commission...