Some of the current NBs are indeed accepting new clients, but I believe without a guarantee that the companies will be actually certified.
With the current covid situation, most of the audits, including initial audits (not only surveillance) are conducted remotely, which is very tricky and difficult. In general, I do not know if an effort for MDD certificate right now worth the risk.
Making a contract with an NB right now does not mean that you are going to be certified.
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Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece
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Original Message:
Sent: 23-Sep-2020 04:40
From: Richard Vincins
Subject: ISO 13485 Cert and CE Mark under MDD?
Hello Ronald,
There has been an "expedited" or "guaranteed review period" by Notified Bodies, but as Spyros commented, use some caution. Notified Bodies repeatedly say in public forums they are only offering a service, nothing more. However, I personally have an issue with that mentality and hope the National Authorities and Competent Authorities are having serious conversations with Notified Bodies because they are acting as an extension of the Competent Authorities. It is not "just a service." Off soapbox ... haha.
To answer your question, because of the movement of the compliance date to May 2021 many Notified Bodies extended the ability continue re-certifying EU MDD products (the EC Certificate) instead of beginning of this year saying companies would need to move directly to EU MDR. In fact, some Notified Bodies have said they will take new clients and new EU MDD CE Certification applications up to around the end of this year on a case-by-case basis. You would have to call around to see who is taking on new clients. Also keep in mind the issue with getting new ISO 13485 certification/EU MDD quality system certification during current times as onsite audits are not being performed normally - a Stage 2 initial certification most Notified Bodies have stated this needs to be onsite. I understand many auditing organisations (not just Notified Bodies) are trying to be creative with performing audits considering the current state of the world.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 23-Sep-2020 02:14
From: Spyros Drivelos
Subject: ISO 13485 Cert and CE Mark under MDD?
Hi Ronald,
"Fast tracking" was a procedure of many NBs so far, and some of them charged significantly higher amounts for the certificates. However, in most of the cases "fast tracking" was illegal, because the whole philosophy was "i pay a lot of money to get the certificate as soon as possible with the lowest possible effort". It seems like a bribe, isn't it?
So, be careful on that. There are some NBs that will not operate under MDR and might searching for last minute good compensation.
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Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece
Original Message:
Sent: 22-Sep-2020 14:34
From: Ronald Warren
Subject: ISO 13485 Cert and CE Mark under MDD?
I've had a few inquiries about certification to MDD. Does anyone know whether NBs are willing/able to take on new clients to "fast track" ISO 13485 certification and device CE marking under the MDD given the transition to MDR on 5/26/21? Appreciate your opinion on this.
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Ronald Warren RAC
San Diego CA
United States
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