Articles โ Resources โ AKRN Social network
Impact of MDCG 2021-21 on SARS-CoV-2 IVDs
Recently, the Medical Device Coordination Group (MDCG) has published a new document (MDCG 2021-21) to guide MedTech stakeholders in the performance
PER According to IVDR
Performance Evaluation The EU Regulation 2017/746, commonly referred to as In Vitro Diagnostic Medical Device Regulation (IVDR), imposes
IVD Clinical Performance Studies
IVD Clinical Performance Studies Before commencing a clinical performance study, the sponsor shall determine and consider the requirements for
What is the IVDR?
In-vitro medical devices Regulation (IVDR) The in-vitro medical devices Regulation (IVDR) is the new harmonized regulatory framework to ensure
ISO 20916 new international standard for IVDs
Good study practice for clinical evaluation of in-vitro diagnostic medical devices The International Standard for clinical performance studies
ISO 20916 for IVD vs. ISO 14155 for Medical Devices
The ISO 20916 is specific for in-vitro diagnostic (IVD) medical devices The ISO 20916 was released in 2019 and uses definitions and concepts
Classification of IVD under the IVDR
In-vitro diagnostics (IVDs) are medical devices to be utilized in vitro to examine examples obtained from the human body to retrieve data about a
European Medical Device Law
Navigating the legal framework for placing Medical Devices (MD) and In Vitro Diagnostic medical devices (IVDs) on the EU market can seem complicated
In Vitro Diagnostic (IVD) devices and European CE Marking
The in vitro diagnostic (IVD) devices sold in the European Union require a CE mark to certify that the device complies with the current European
AKRN Social Network