EUDAMED and GUDID – What’s Changed?
The European Database for Medical Devices (EUDAMED) EU-MDR, the European Union’s Medical Device Regulation is intended to support both pre-market product registration processes and post-market surveillance & vigilance activities by national regulators across the...
Medical Device Manufacturing and COVID-19: Challenges and Opportunities
Medical Device Manufacturers are grappling with disruptions to their businesses as a result of the coronavirus pandemic, with many experiencing an adverse impact on their supply chain and operations, their financial expectations and emergency response plans. The need...
EUDAMED Go-Live is March 2020: Why waiting for more Technical Specifications is NOT a winning strategy
EUDAMED deadlines remain unchanged – the go-live date is still March 26, 2020 with the Date of Application for device registration/submission standing at May 26, 2020. Yet, we’re nearing the end of 2019 with most med device companies still struggling to fully...