#ivds

This article talks about the 5 best practices for preparing Class C IVDs under EU IVDR 2017/746 regulations for regulatory approval.

This article talks about the understanding PMCF plan under the EU MDR 2017/745 to monitor the safety and performance of the device.

This article talks about the medical device registration requirements in GCC countries for compliant market entry of products.

This article talks about the registration requirements of In-Vitro Diagnostic Devices (Reagents) for compliant market entry of the products

This article talks about the requirements of analytical performance reports (APRs) for IVDs under EU IVDR 2017/746 to test and evaluate the

This article talks about the Japan's medical device labeling requirements for manufacturers on the latest amendment for compliant market ent

As you may know, CE marking is required to place any In Vitro Diagnostics devices (IVDs) in the European Union (EU). CE marking indicates th

Class A IVDs under European Union In Vitro Diagnostic Devices Regulations (EU IVDR) 2017/745 require self-certification. The manufacturer is