The Commission of the European Union (EU) has published the results of its survey of EU Notified Bodies (NBs) regarding their responsiveness to requests for conformity assessments of COVID-19-related medical devices.
According to a posting to the website of the Regulatory Affairs Professional Society (RAPS) in early July, the Commission’s survey was intended to quantify lead times for completion of the conformity assessment process of medical devices requiring NB review. The survey was initiated by the Commission in early May when it sent surveys to 55 different EU NBs. The Commission received completed surveys from 37 NBs.
In brief, 63% of responding NBs indicated that they could process a change notification under the MDD within 15 days. However, only 36% of NBs said that they could process a new application within that time frame, with another 32% indicating that a new application could be processed with a month.
Importantly, according to the survey results, 16% of responding NBs indicated that they are not currently taking any new applications, and 8% are not accepting change notifications.