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 ...
2023/12/14 -This article talks about an overview of assigning IVDR codes in conformity assessment applications to ensure safety and compliance market access of products ...
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.
2024/4/15 -This guidance document is then relevant for compliance with the IVDR regarding safety reporting. MDCG 2022-10 provides further guidance on the interface between ...
2024/2/6 -The IVDR is ... Download the free Starter Kit, which gives you an overview of the regulatory landscape and includes the IVDR checklist in PDF and DOCX format..
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 ...
2023/6/23 -The way in which the manufacturer declares their compliance with the applicable conditions is disclosed by the manufacturer in the completed form. The template ...
2023/8/24 -The biggest change from the IVDD to the IVDR is the introduction of a risk-based approach to classification in combination with increased notified body ...
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 ...
2023/10/18 -The main purpose of the new IVDR is to enable IVD manufacturers to bring safe devices to the market. ... As an IVD manufacturer, by following the basic steps ...