For those manufacturers that have already completed an initial project to comply with MDR by May 2021, it may be tempting to sit back and delay their IVDR efforts. Business disruption caused by the pandemic and the subsequent mass shift to remote operations, which prompted the EU to delay MDR implementation deadline by one year – may also have added to the belief among some business leaders that there is ample time remaining. But the scale of these compliance tasks and the wide-ranging impact regulation has on end-to-end operations and the supply chain is often underestimated, and only uncovered during the initial assessment stages of a compliance project.
Manufacturers must ensure they comply with every aspect of IVDR demands to avoid financial impact, operational disruption and permanent damage to brand reputation in the event of consumer harm caused by device quality or traceability issues.
