2024/1/18 -Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) contains different legal provisions that allow Member States to determine language ...
2024/4/10 -Ensuring Compliance: Understanding the IVDR's Summary of Safety and Performance (SSP). The world of in vitro diagnostics is all about accuracy and reliability.
2024/2/6 -The IVDR, the In vitro Diagnostic Regulation, replaces the IVD Directive. The IVDR introduces significant changes. Here is an overview.
2024/4/15 -This guidance document is then relevant for compliance with the IVDR regarding safety reporting. MDCG 2022-10 provides further guidance on the interface between ...
2024/1/17 -An application for performance study of an in vitro diagnostic medical device shall contain the documentation listed in this document. Please fill in the form ...
2024/2/9 -What should the medical device technical file contain? The EU MDR and IVDR specifies the 'technical documentation' that you must submit to the regulator to be ...
2024/1/11 -Is your risk management process adequate? 4 – Unique device identification. The IVDR will place far more emphasis on supply chain traceability, and thus you ...
2024/3/5 -Understand what is required of a technical file and how to structure one in order to successfully sell your medical device in the EU market.
2024/4/17 -In vitro diagnostic devices (IVD) include any medical device used in medical diagnosis, such as reagents, kits, instruments, equipment, and software. It is ...
2024/1/12 -The IVDR is a more comprehensive and stringent regulation designed to improve the safety and performance of in vitro devices placed on the EU market. The IVDR ...