Hello Anon,
Simply, if you have a current IVDD General List device, self-declare, which will now be a Class B under the EU IVDR, you would need to be fully compliant and achieve an EC Certificate by 26 May 2022 in order to continue selling the device. When "placing on the market" the device would need to be at a distributor within the European Union in order for the device to continue in the distribution chain. I believe you have a mis-understanding that if you are currently selling the device, you can keep selling the device, this is not true. Just because you have been selling the device for many years, does not mean you can continue selling up to 2025. IVD devices which are now Class B, C, and D under the EU IVDR need to be compliant by 26 May 2022.
To answer your other question: no, a Notified Body can not review your General List device to receive an IVDD CE Certificate to continue selling. According to the conformity assessment route in the IVDD this is not possible - a CE Certificate can be issued to List A, List B, and the self-test/near-patient which also fall under Notified Body review. A Notified Body will not/can not review a self-declare device just to achieve an EC Certificate to give your company more time. And as Erik said, it will not give much time because even with an IVDD EC Certificate there is only 2 more years of transition.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
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Original Message:
Sent: 25-May-2021 01:47
From: Erik Vollebregt
Subject: IVDD/IVDR Compliance for Self-Certified Products
Dear anon,
Can self-certified IVD near-patient devices that have been on the EU market for numerous years without issue remain on the market until 2025 under the IVDD?
- If you've placed them on the market before the date of application, they can be sold off until 27 May 2025. Don't know what you mean with "without issue". There is no grace period foreseen in the IVDR for self certified devices that need a notified body CE certification under the MDR.
If not, is it possible to have a Notified Body audit the current IVDD compliant Technical Files (along with the QMS which is already IVDR compliant) and issue an IVDD CE Certificate to buy some time prior to the 2025 deadline.
- Normally not, because there is a reason why you self-certified under the IVDD in the first place. Unless the intended purpose of the device changes, say, from a near patient test to a self test (for which you do need a notified body under the IVDD), you will not be able to do that. If you even contemplate doing an IVDD assessment close to IVDR date of application, you wouldn't 'buy' much time. Maybe better to go full pull and get the IVDR certification out of the way, if you can still get a slot at a notified body for timely certification, because this is the bottleneck for everyone at the moment.
I don't understand the remark that some of your devices would have an IVDD certificate, because that would solve the problem, right? Or do you mean IVDD declaration of conformity? That would fit the problem.
Best regards,
Erik
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Erik Vollebregt
Partner
Amsterdam
Netherlands
Original Message:
Sent: 24-May-2021 13:25
From: Anonymous Member
Subject: IVDD/IVDR Compliance for Self-Certified Products
This message was posted by a user wishing to remain anonymous
Can self-certified IVD near-patient devices that have been on the EU market for numerous years without issue remain on the market until 2025 under the IVDD?
The devices will be classified as B under IVDR.
If not, is it possible to have a Notified Body audit the current IVDD compliant Technical Files (along with the QMS which is already IVDR compliant) and issue an IVDD CE Certificate to buy some time prior to the 2025 deadline.
For the big picture... Some devices would be IVDR compliant and have an IVDR CE certificate and others would have an IVDD Certificate. It would allow us to determine if we would want to keep the IVDD compliant products on the market without developing IVDR compliant Technical Files and related.
Thanks