Cancellation of ‘sell-off’ date (MDD/MDR and IVDD/IVDR) All products placed on the market under the MDD or the Directive 98/79/EC on in vitro diagnostic medical devices (IVDD) before May 26 ...

In recent years, the in vitro diagnostics (IVD) regulatory landscape in Europe has changed and we are now in the transition from IVD Directive 98/79/EC (IVDD) to In Vitro Medical Devices ...

Navigating The MDR and IVDR and Best Strategies for Compliance SAE Media Group is proud to announce the launch of the Medical Devices and IVD Conference, taking place on 14 – 15 November 2022 in ...

Germany is one of the largest markets for IVD devices worldwide. In response to the growing COVID-19 pandemic and shortage of enough labs to take COVID-19 tests, IVD manufacturers came up with new ...

"DNV is looking forward to working with manufacturers of all classes of IVD devices to help them access the EU market," said Cecilie Gudesen Torp, Global Director Medical Services, Supply Chain ...

This report analyzes in vitro diagnostic (IVD) technologies and devices used in hospitals and point-of-care (POC) settings, focusing on market trends, drivers, opportunities, and competitive ...

The Drug Controller General of India (DCGI) has added in-vitro diagnostic (IVD) medical devices including those for diagnosis of Covid-19, ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) ...

Such medical device organisations can be involved in one ... and medical devices focusing on the transition to the new IVD/Medical Device Regulations, MDSAP and ISO13485:2016.

The safety and effectiveness of such devices is therefore crucial to public and personal health. The EU introduced the IVDR in 2017, replacing its previous In Vitro Diagnostic Directive 98/79/EC (IVDD ...