FAQ series “Main Facts on IVDR“
The countdown has started! The new European Regulation for in vitro diagnostic medical devices (IVDR) came into effect in May 2017. The IVDR is relevant both for manufacturers and for institutions and companies supplying devices that were not covered by the previous EU Regulation. The clock is now ticking for all stakeholders. Over the next five years, all in vitro diagnostic medical devices (IVDs), governed by the IVDR, will need to obtain new certificates or recertification for their products.
Our FAQ series “Main Facts on IVDR” provides information on what you should now do as a (potentially) affected company.