In light of the severe disruption caused by the COVID-19 pandemic, the European Commission (EC) has taken the decision to allow notified bodies to perform remote audits of medical device and in-vitro diagnostic medical device manufacturers.
Given the implementation of travel restrictions and quarantine measures in both Member States and non-EU countries to combat the spread of COVID-19, notified bodies have struggled to complete on-site audits that form a vital part of conformity assessments. This has led to calls from both manufacturers and notified bodies for temporary measures such as remote audits to be employed.
The EC has reached this decision by acknowledging that audits still need to take place to prevent a shortage of devices, especially given the clinical need for certain devices used in the treatment of COVID-19. However, the commission also highlights the importance of on-site audits in ensuring the safety of devices and the consequent need for remote audits to have a minimal impact on the overall efficacy of the inspection process.
In allowing remote audits, the EC essentially decrees that this arrangement will only be possible during a time when the obstacles created by COVID-19 are present. This amendment does not entitle on-site audits to be replaced with remote inspections for the sake of convenience. Furthermore, the use of remote audits should only be conducted to prevent an imminent shortage of safe devices. Remote audits will only be accepted following a case-by-case analysis of each proposed assessment.
As such, notified bodies are required to undertake a risk-based approach which includes a thorough inspection of all technical information provided by the manufacturer. Additionally, notified bodies must clearly document their approach to remote audits and subsequently notify the EC of how and why they used the methods they did during the audit.
To read the EC’s notice in full, click here.