what need to develop a compliance strategy under the IVDR?
In order to develop a compliance strategy under the IVDR, the European Commission recommends that manufacturers do a gap analysis and action plan, including the following:
Assess the impact of adapting to new regulations on products
Check new classification specifications
Confirm the compliance assessment path
Check and change existing technical documents
Check and upgrade the quality management system
Check the sufficiency of existing clinical evidence
Risk Management
Check product manuals, labels
Ensuring the adequacy of post-market surveillance arrangements
Prepare a post-market performance tracking plan
Prepare for new vigilance requirements
Ensuring the fulfillment of traceability obligations
Post time: May-27-2022