MDCG Q&A on Clinical Investigations: Overview
The article briefly overviews the European regulatory framework for clinical investigations.
The article briefly overviews the European regulatory framework for clinical investigations.
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, has issued the first revision of guidance notes to the manufacturers of Class I medical devices initially published in December 2019. In particular, the document intends to...
The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices, issued a compliance program describing the inspections related to CDER-led or CDRH-led combination products. The document provides the requirements for different...
The Therapeutic Goods Administration (TGA), a division of Australia’s Department of Health responsible for medical devices circulation, issues new guidance dedicated to the evidence requirements. The new guidance published by the TGA is intended to provide entities...
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK authority responsible for medical device regulation, published guidance aimed to assist medical device manufacturers facing notified body withdrawals. According to the guidance, if a notified body...