In Vitro Diagnostic Medical Devices Regulation – Summary of changes and impact for manufacturers
The new In-Vitro Diagnostic Medical Devices Regulation (2017/746/EU) (IVDR) was published in May 2017. It will replace the existing In-Vitro Diagnostic Medical Devices Directive (98/79/EC) (IVDD) in May 2022, after a transition period of 5 years.
The regulatory basis of the IVDR is similar to the IVDD’s, but the IVDR introduces new or more stringent requirements for economic operators, notified bodies (NBs) and some sections of the technical documentation.
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