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LRQA has produced a variety of useful resources about the progress and requirements of the new In vitro Diagnostic regulation.
A comprehensive overview of the key changes which will affect all Medical Device and In-Vitro Diagnostic Medical Device manufacturers.
The new IVDR requires sampling of technical files for review by a Notified Body for devices classified as B or C under the regulation. This whitepaper provides details and identifies LRQA’s requirements for sampling technical files of these devices.
LRQA’s medical device technical experts answer some frequently asked questions on how to implement the requirements introduced by the new regulation.
Are you prepared for the changes? Now in its final stages, the new In Vitro Diagnostic Device Regulation (IVDR) will replace and repeal the existing In Vitro Diagnostic Device (IVD) Directive 98/79/EC when it is published, currently estimated for Q1 2017.
This interview is a three-part series where Theresa shares her thoughts on the new regulations, and how the changing regulatory landscape impacts manufacturers and Notified Bodies.
This IVDR Infographic helps highlight the key dates and changes within the new ln Vitro Diagnostic Device Regulation.
An important first step for manufacturers in getting their in vitro diagnostic device (IVD) into the European market, is classifying their IVD.
Manufacturers looking to launch their in vitro diagnostic device (IVD) within the European Union (EU) need to comply with the relevant EU in vitro diagnostic device regulations.