The European Commission has announced its intention to postpone the implementation of the new Medical Device Regulation (MDR) following the Coronavirus outbreak.
The European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) will replace the Medical Device Directive (MDD) and In Vitro Diagnostic Directive (IVDD) beginning with the MDR that takes effect May 26, 2020.
Medilink WM patron MasterControl provides an informative article, highlighting to industry that software must not be overlooked when considering MDR requirements and compliance.
The regulatory landscape for medical devices is presently very challenging. Industry is well aware that the three year transition period from a directive to a regulation ends on the 15th of May 2020, whereupon the new regulatory framework (MDR) will apply in full. This will be followed in May 2022 with the new IVD regulations.