Something to watch out for! Since the new EU Regulation on in-vitro diagnostic medical devices (IVDR) came into effect in May 2017, the clock is ticking for all parties involved in the manufacturing of in-vitro diagnostics (IVD). For the first time, this group includes many institutions and companies to which the previous EU directive had not applied. All devices falling under the scope of the IVDR will require new or recertification within the next five years.
In connection with the new IVDR, there are three questions which you need to answer now: