Trade group MedTech Europe is calling on authorities to permit notified bodies to conduct virtual audits of medical devices and in vitro diagnostics for the duration of the COVID-19 pandemic, in order to clear a potential bottleneck.
The group argued in a paper published earlier this week that current restrictions to travel and access to manufacturing sites meant that medtech companies are currently unable to effectively make use of the one-year delay to the Medical Device Regulation (MDR).
The paper asserts that this current inability to be audited under MDR and In Vitro Diagnostic Regulation (IVDR) could lead to an overwhelming surge in demand for in-person audits when travel restrictions are lifted.
In order to prevent this leading to a logjam scenario, MedTech Europe has urged the use of technologies to conduct audits, which they argue would enable notified bodies to examine facilities and products without visiting sites in person.
In particular, it says that virtual initial quality management system audits should be allowed for new technologies or changes to existing products that "may be considered critical or useful to healthcare systems." It says that technology including smart glasses, webcams and teleconferences could “allow site manufacturer representatives to walk auditors through the manufacturing line."