Guidance Clarifies EU Position On Alternatives To Notified Body On-Site Audits

A new guidance on notified body audits during COVID-19 quarantine has been issued by the European Commission’s Medical Device Coordination Group (MDCG) to formally outline when alternatives to on-site audits, such as virtual audits, can take place for devices assessed in the context of the EU’s medical device directives.

Additionally, a task force has been set up under the MDCG Notified Body Oversight (NBO) working group tasked with the development of guidance to define the operational implementation details of...