EU IVDR Regulation: A Brief
IVDR is a separate regulation compared to the European medical devices regulation. However, it [...]
Performance Plan Evaluation Under the EU IVDR 2017/746
Most of us are familiar with clinical evaluations for medical devices. Easy peasy. But [...]
EU In Vitro Diagnostic Regulation (IVDR): Frequently Asked Questions
The regulatory landscape in Europe is changing. In 2021, the new medical device regulation [...]