EU Commission Opens Door to Remote NB Audits...Finally!
Updated: Jan 21, 2021
Yes it’s true and we thought you would like to know! Finally acknowledging that COVID is not going away anytime soon, and with the EU MDR deadline looming, the European Commission issued a notice stating that European Notified Bodies will now temporarily be allowed to remotely audit their medical device and IVD clients and their suppliers. This comes on the heels of a December recommendation by the Medical Devices Coordination Group (MDCG) to allow remote audits. Most Member States concurred with that recommendation, after manufacturers and Notified Bodies pressed the issue, and the Commission agreed as well…with some caveats. Read the notice here.
Editorial - Yeah... this brings in more challenges and a new way of doing this... check out our Remote audit Webinar.
Going forward EU Notified Bodies may choose to offer remote audits but keep in mind...
It’s not forever – The Commission clearly indicated that the ability to conduct remote audits is temporary and obviously brought on by extraordinary circumstances. As such a “Notified Body’s decision on certification is limited to the time strictly necessary to allow for a proper on-site audit to take place as soon as possible.” That means you might be granted a remote audit soon and have to get an on-site audit later in 2021 when in-person contact and group gatherings are safer. Don’t expect remote audits to become the “new normal.”
Notified Bodies must justify remote audits on a case-by-case basis – In short, remote audits are not automatic and it’s not your call to demand a remote audit. The EC has clearly put the onus on Notified Bodies to evaluate each situation and document why an on-site audit is not possible. The EC states Notified Bodies should “not go beyond what is required to ensure continuous availability of safe and performant devices.” In doing so the Commission is clearly signaling that on-site audits are still very much preferred if practical and if a remote audit is chosen, it must be justified in cases where “the inability to carry out such an on-site audit could prevent granting access or ensuring continued supply of devices to the market.” This means your Notified Body might not grant you a remote audit unless you can prove a potential disruption of supply, or the circumstances make an on-site audit unsafe or impractical. Start building your case.
This notice was issued on January 11, 2021 and it closes by “inviting” Member States (countries) to submit information on how they will comply with these “temporary extraordinary measures” along with an estimate of how long they will leave them in place. Like everything else related to COVID the situation is fluid so we recommend that you contact your Notified Body for more information.
Edit - 20 Jan 2021 -
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