What information must be included in the technical documentation?

... In Vitro Diagnostic Medical Devices (Directive 98/79/EC)]. Though this report is aimed principally at manufacturers of IVD medical devices, the concepts and ... This Guidance Document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their quest to comply with ... Veristat offers a team of scientific-minded regulatory experts who understand how to develop the documentation and elaboration needed to support the CE mark ... Mar 17, 2025 ... The MDR and IVDR require all medical devices and in vitro diagnostics (IVDs), including those that have been on the EU market for many years, to ... In vitro diagnostic medical devices (IVDs) placed on the EU market must be certified against the new requirements. Covid 19 Blood Sample and Rapid Test of ... This consultation aims to confirm views on aligning classification rules, principles, and definitions with the European Regulation 2017/746 for in vitro ... ISO 20916:2019 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice ... This publication ... The new IVDR, like Regulation 2017/745 (MDR), adapts EU legislation to technological progress, medical developments and progress in lawmaking. May 26, 2021 ... ... IVDs. In 2017, the EU put into force its new regulations on medical devices and IVD. This development obligated the Swiss government to ... in vitro diagnostic medical devices ( IVDs ) compliant with the EU in vitro diagnostic medical devices directive (IVDD) can be placed on the Great Britain ...