The #MDCG has released a document providing guidance for NBs, distributors and importers on required certification activities per Article 16(4). It covers a variety of topics, including Content of Certificates and Auditing requirements.

🔗 Original Document :  https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-23_en.pdf

#MDRG #mdrguide #IVDR #MDR #medicaldevices #ec