1st August 2023 UK Government announces indefinite extension to CE marking > Read More...
WE ARE NOW RECRUITING - Visit our VACANCIES page for more information.

 

Summary

At the same time as the EU MDR (2017/745) came into force, so the EU IVDR  (2017/746) also superseded the old IVD directive, which had become unfit for purpose due to significant advances in technologies and within the Medical Device industry. The EU IVDR came fully into force in 2017 and introduced a significantly more stringent regulatory environment for in vitro diagnostic medical devices.

The IVDR covers equipment (including receptacles) intended by the manufacturer to be used to in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information e.g. concerning a physiological or pathological process or state, on the predisposition to a medical condition or disease, the safety and compatibility of a process with potential recipients or to predict treatment response or reaction.

 

 

See our new In-Vitro Diagnostic Medical Devices Directive page for the UK

How Can We Help You?

Ask a question, or request a callback.
Please type your full name.

Invalid email address.

Invalid Input

Test description

Invalid Input

Invalid Input

Please make a selection

Invalid Input

Invalid Input