Until when can we CE-mark and sell MDD class 1 devices?

[Crispyskydiver]

Note that if you have class I devices that have been placed on the market prior to May 26th, 2020 and are correctly placed on your declaration of conformity, you may qualify to meet the newly published corrigendum that is to be voted on in the next couple days. However, you must ensure the two requirements are met:
1. The devices are class I devices without EC certificates that are on the declaration of conformity prior to May 26, 2020.
2. The class I devices under MDR conformity assessment rules are required to be up-classified and undergo NB assessment.

If both of those conditions are true, then you can continue to market the class I devices under MDD until may 26, 2024.

This is designed to give a buffer for manufacturers and NBs to undergo necessary up-classification of legacy devices.

 

[Son of Paperman]

Note that if you have class I devices that have been placed on the market prior to May 26th, 2020 and are correctly placed on your declaration of conformity, you may qualify to meet the newly published corrigendum that is to be voted on in the next couple days. However, you must ensure the two requirements are met:
1. The devices are class I devices without EC certificates that are on the declaration of conformity prior to May 26, 2020.
2. The class I devices under MDR conformity assessment rules are required to be up-classified and undergo NB assessment.

If both of those conditions are true, then you can continue to market the class I devices under MDD until may 26, 2024.

Thank you for that succinct description.
However not clear to me is:

1. "up-classification":
   Does that mean that devices must have a higher class under MDR than they under MDD? Our MDD class 1 products remain class 1 MDR
2. "undergo NB assessment":
   Several of our class 1 devices will not require NB authorisation under MDR. Does that mean that our devices that remain class 1 and the ones that remain both class 1 and don't need a NB, do not meet condition 2 and thus do not qualify for the corrigendum?

Additional question to all:
From time to time I read articles and postings about Class 1 medical devices using the following terms as if they are official elements in regulatory documentation:

• 1s: Devices that are placed on the market in sterile condition
• 1r: Reusable surgical instruments (r stands for “reusable”)
• 1m: Devices with a measuring function

Where does this terminology come from and where in official regulatory documentation is it defined? Is it an official subclassification?

Thank you in advance.

 

[Ronen E]

Does that mean that our devices that remain class 1 and the ones that remain both class 1 and don't need a NB, do not meet condition 2 and thus do not qualify for the corrigendum?

First, there is no "qualify for the corrigendum". The corrigendum applies to all, unconditional. You probably mean "do they qualify for the extension/concession promulgated by the corrigendum?"
The answer is that the only devices that remain class 1 and benefit from that new extension are those that are classified 1r under the MDR.

Where does this terminology come from and where in official regulatory documentation is it defined?

This terminology is unofficial and used as a convenience shorthand. Devices classified as "1m", "1s", and "1r" are still all class 1 devices, officially. Nonetheless, they have some special provisions that apply to them.

 

[Crispyskydiver]

The first part of what Ronen says is correct, in terms of the corrigendum applying to all. I meant in terms of qualification for extension. However, to qualify for the extension, Class I devices via MDD conformity assessment must have an EC cert or have to be any previously self-declared class I devices under MDD that now fall under Class I m/r/s or Class IIa and above (anything needing NB scrutiny) via the MDR conformity assessment.

If your product was class I self-declared under MDD, and continues to be class I self-declared under MDR, the extension does not apply.

 

[Ronen E]

The first part of what Ronen says is correct... However, to qualify for the extension, Class I devices via MDD conformity assessment must have an EC cert or have to be any previously self-declared class I devices under MDD that now fall under Class I m/r/s or Class IIa and above (anything needing NB scrutiny) via the MDR conformity assessment.

(Emphasis added)
The word However above suggests that we are in some sort of disagreement, but I think we're not. Your statement is accurate, but it's possibly difficult to decipher by someone less used to regulatory language, and while it's complete, it exceeds @Son of Paperman's question. My statement was intended to answer his question directly, not necessarily to cover the entire scope of the (corrected) article.

Specifically, when I related to "the extension" it related to the latest, added through the corrigendum (that's why I wrote "that new extension"). The grace period allowed for devices already certified under the MDD (Is, Im or higher classes) was there from the start so I don't see it as "an extension".

I don't see how a self-certified device under the MDD can become a 1m/1s device under the MDR - have any related definitions changed? So the scenario of MDD-self-certified to MDR-class-1-NB-scrutinised boils down to 1r (because there was no "1r" under the MDD).

If you think my statement is not accurate I'd be grateful if you highlight in what way and why.

 

[Biomedical_engeener]

Does the custom made implants (class I under MDD --> class III under MDR) qualify for the extension promulgated by the corrigendum? The corrigendum does not exclude nor include custom made devices.
Many thanks

 

[dgrainger]

How would you get a class I for an implantable device under MDD? Rule 8 has a minimum class of IIa.

 

[Biomedical_engeener]

How would you get a class I for an implantable device under MDD? Rule 8 has a minimum class of IIa.

You are right! I mixed it all up.