The Auditing Process as Part of the MDR Conformity Assessment Procedure

What manufacturers of medical devices should know about regarding the auditing process in MDR conformity assessments

The most common conformity assessment procedure for medical devices higher than class I is the procedure following Annex IX of the MDR. This annex requires assessment of the quality management system and – depending on the classification of the medical devices concerned – assessment of the technical documentation. 

At TÜV SÜD, an initial conformity assessment procedure in accordance with Annex IX starts with the (pre-) application phase. Once this phase is completed, the assessment of technical documentation starts followed by an initial audit. This initial audit comprises two stages, a “stage 1 audit” and a “stage 2 audit”. The certification phase commences when all technical documentations have been assessed with a positive result and all non-conformities are closed. In the certification phase the certification body performs an independent assessment of all previous activities conducted by the Technical Documentation assessment experts and auditors. As soon as any questions and concerns have been closed certification can be granted. 

Remark: After successful certification, surveillance activities start. Those cover e.g. regular audits and technical documentation assessment following a sampling plan.