This whitepaper explains the main changes in requirements for compliance to the IVDR, compared to the IVDD, explains the different routes to market and also gives an update on the status of the implementation at the European level
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.
Download our recent whitepaper which delivers deep insights about In vitro diagnostic medical devices regulation – summary of changes and impact for manufacturers.