NBCG-MED has published operational elements for the application of hybrid audits to QMS assessments under the MDR and IVDR, including on-site requirements, ICT use and audit planning.

Team-NB has published a proposal for a risk-adaptive surveillance system under the MDR, covering surveillance audits, unannounced audits, technical documentation sampling and PSUR updates.

Team-NB has published a proposal for a risk-adaptive surveillance system under the IVDR, covering surveillance audits, unannounced audits and technical documentation sampling.