The European Commission came through with their promise to provide more information on COVID-19 related product assessment by Notified Bodies. They conducted a survey under notified bodies in charge of the certification of COVID-19-related medical devices and IVDs and published a report on their findings.
The first relevant finding is that only 27 notified bodies out of the current 55 cared to respond to a request for data sent to them by the European Commission. Surprising to see that a third of the notified bodies is not even responding to a rightful request by the Commission; but it explains some manufacturers have to continue regular communication with their notified body.
Thirty-five percent of the notified bodies that responded indicated that they would take more than 15 days to even get a quote in place for the work associated with the conformity assessment. Change notifications for Corona related products essentially cannot be expedited. Extensions of scope for companies already having similar devices on the market are relatively short, and medium time span is needed if the company already has notified body certificates for other products.
For product reviews the timelines are shorter than normal timelines experienced at notified bodies. But still for a class IIa essential COVID product, half the notified bodies need 3-6 months for the review, whereas in such review a total of perhaps 10 mandays of review and audits is done.
For IVDs we see a disturbing response. Only for some notified bodies will they have the possibility to do any reviews, and of those, a large percentage will take a substantial time. Even if the review on self test is focusing on correct use by patients, rather than full performance testing.
For higher risk products, only one NB is accepting applications, but the review might be fast and focused.
A good read, but that’s it. No conclusion, no opinion, no call for action, just data from the survey. But a key message is clear from the report: when in a hurry due to the need for COVID related products, choose your notified body wisely, as their timelines of quoting and review are diverging widely !!
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Keep safe!!