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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.
Under the new IVDR, an estimated 80% of devices are expected to require Notified Body involvement as opposed to 20% under the current directive.
The new IVDR requires sampling of technical files for review by a Notified Body for devices classified as B or C under the regulation.
Download our guide to understand the changes introduced in the In Vitro Diagnostic Device Regulation (IVDR) related to self-declare 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? The new In Vitro Diagnostic Device Regulation (IVDR) was published in May 2017 and replaces the existing In Vitro Diagnostic Device (IVD) Directive 98/79/EC.
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.
Classifying an in vitro diagnostic device is an important first step for manufacturers in getting their devices into the European market.
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.