EC details device assessment capacity amid COVID-19

Regulatory NewsRegulatory News | 06 July 2020 |  By 

European notified bodies reported on their ability to conduct conformity assessment quickly for COVID-19-related medical devices and in vitro diagnostic medical devices, in response to a survey conducted by the European Commission (EC).
The survey sought 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 European Union (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.

The report meets a commitment the EC made to provide manufacturers and market operators information about capacity and timeframes for conducting conformity assessments for COVID-19-related medical devices. The survey was sent in early May to 55 notified bodies; responses were returned by 37.  
In responding to the survey, about two thirds (63%) of notified bodies said they could process a change notification under the medical devices directive (MDD) within 15 days. For new applications, about one third (36%) of notified bodies could process a new application within this time frame. Another 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.
“It is important to highlight that 16% of notified bodies are not taking any new applications,” said the EC, adding that just 8% of notified bodies are not accepting change notifications.
The survey also asked notified bodies about the amount of time to qualification of a new critical supplier or subcontractor for an existing client. For new critical suppliers, 50% could approve qualification within one month, while 56% could approve qualification of a subcontractor within one month.
Almost half (44%) of responding notified bodies said it would take from 1-3 months to approve addition of a new category or group of COVID-19-related essential devices that is in a category not covered by an existing certificate to that certificate. Twenty-one percent said they could achieve this in less than a month, with the remaining respondents reporting that it would take more than 3 months to complete the process.
However, when the device is in a category covered by the product range of the existing certificate, 30% of respondents said they could approve its addition within a month, and another 53% could do so in between 1 and 3 months.
Conformity assessments of COVID-19-related Class I sterile devices or those with measuring functions (Class Is or Im) for a new client under the MDD could be completed by 70% of responding notified bodies within 3 months; 9% of this group could complete the process in under a month.
About half (47%) of responding notified bodies pegged the minimum time to complete a conformity assessment for COVID-19-related Class IIa devices under Annex II, V or VI of the MDD at 3-6 months; another 44% said they could complete this process in 3 months or less. For certificates obtained under Annex IV of the MDD, most (56%) respondents also said the process could take 1-3 months, with the remaining 44% saying they could complete conformity assessment in less than 3 months.
For Class IIb devices, an Annex II conformity assessment could be completed within 3-6 months by a majority of respondents, while Annex II and IV assessments would take an average of 6-12 months. “[T]he limited number of notified bodies designated to carry out activities under Annex III and IV could play a role in the increased time for completion,” noted the EC.
For the limited number of notified bodies that are designated under the Medical Devices Regulation (MDR) rather than the MDD, new applications for Class Is or Im devices under Annex IX or XIA would take an average of 1-3 months. “It must be stressed that around 10% of notified bodies are not currently accepting applications under this route,” the EC said.
Class IIa devices seeking conformity assessment under these annexes could expect the notified body to take from 3-6 months; for Class IIb devices, the time to process the application could extend to 12 months.
Just three notified bodies that responded to the survey are designated to carry out MDR Annex IXB activities; all 3 could complete conformity assessment within 6 months, they said.  
Most existing clients seeking conformity assessments for Class Is or Im devices under Annex IX and XIA could expect to see an application processed in 1-3 months, while for Class IIa devices the time frame could extend to 6 months, according to the survey.  Class IIb devices seeking conformity assessment under these annexes could see applications processed in the 1-6 month timeframe.
For Annex XIB of the MDR, the few respondents accepting these applications reported that they would be able to complete Class IIb application processing within 3 months.
Regarding self-testing devices for COVID-19 submitted under the in vitro diagnostic medical devices Directive  (IVDD) for COVID-19 related devices, “notified bodies expect that under best case scenario situation the time for processing applications will be less than one month (14%) or less than 3 months (14%), “ said the EC.
Just one notified body currently is accepting applications for conformity assessment for Class A sterile, Class B and Class C medical devices under the in vitro diagnostic medical devices Regulation (IVDR); this notified body expected to be able to complete full conformity assessments in under a month.
European Commission


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Tags: devices, EC, medical

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