EU: Availability and capacity of notified bodies to carry out conformity assessments for COVID-19 related medical devices and in vitro diagnostic medical devices
The European Commission (EC) conducted a survey in order to quantify lead times for conformity assessment for the various routes by which COVID-19-related medical devices may be placed on the market in the EU and for which notified bodies need to be involved.
“Each notified body was requested to assess its capacity for different procedures and classes of devices,” said the EC in its report of the survey results.
A total of 55 notified bodies were sureveyed throughout the EU – 37 responded to the survey.
Following are reported some of the survey outcomes:
- 63% of notified bodies said they could process a change notification under the medical devices directive (MDD) within 15 days.
- For new applications, 36%of notified bodies could process a new application within this time frame;
- 32% of notified bodies said a new application for an essential COVID-19-related device could be processed under the MDD in less than a month;
- 16% specified this time frame for change notifications.The survey also investigated the conformity assessment procedure timing for the different device classes.
For more details, please see the survey report from the European Commission.
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
