IVDR Date of Application
Article 110 for the Transitional Provisions of the In Vitro Diagnostic medical devices Regulation (EU) 2017/746 (IVDR) has been amended, providing certain manufacturers with additional time to meet the requirements of this Regulation. The amendment was originally proposed with a lengthy explanation for the extension. Whilst stating that the COVID-19 pandemic has confirmed the need for ...
Placing Covid-19 Related Products On The EU Market
The COVID-19 Pandemic has had a profound effect on people and industries worldwide. Without a doubt, one of the most heavily impacted areas of our society has been the healthcare sector which was inundated with patients and shortages of medical equipment. In this article, we shall look at the impact on In-Vitro Diagnostic medical devices ...
