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MedTech Europe Calls for Allowing Virtual Audits by Notified Bodies

  • Posted by: inetika
  • Category: GLOBAL NEWS

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.