MDR Auditing Process Stage 2

What manufacturers of medical devices should know about the stage 2 audit and the follow-up on MDR conformity assessments

Once all critical findings from the stage 1 audit are closed, a stage 2 audit can be conducted. The stage 2 audit covers all sites of relevance for the products you want to place on the market, including manufacturing and design and development sites. The duration of the stage 2 audits depends on various factors including company size and the number of sites to be covered. After the audit, all findings must be closed and accepted by our auditors.

Once the audit findings are accepted and all technical documentations finalised with a positive result, the certification phase starts.