MedTech Europe Calls for Allowing Virtual Audits by Notified Bodies

MedTech Europe is asking the European Commission and EU member states to release guidance clarifying that notified bodies may conduct audits virtually in place of on-site audits during the pandemic for new devices and in-vitro diagnostics.

The group stressed in a new position paper that going forward the scope of the virtual audits should not be limited to COVID-19-related products.

“Looking ahead and in anticipation of further pandemics, the medical technology industry would strongly encourage allowing ‘virtual audits’ when necessary and consider them as a tool to overcome challenges linked to the CE marking procedure when on-site audits cannot be performed,” the group said.