Class I devices in the extended MDR transition period

[regularengineer]

Are all Class I devices under MDD expected to be included in the MDR transition period through 2028?

From what I have seen, only certain Class I devices included in the extension (sterile/measuring function/reusable). My team is working on a product that is Class I medical device software under MDD, and we are wondering if we can continue to leverage the MDD certificate/CE mark through this transition period.

I am aware that Class I devices were to be transitioned in 2021, but wondering if anyone is aware of some "wiggle room" so to speak.

Thanks in advance

 

[KShaw]

Hey there,

The extension will only apply to legacy devices, i.e. those scenarios mentioned under Article 120:

• Devices that did not require NB intervention under the MDD but require under the MDR.
• Devices covered by a valid Directive CE certificate.

So "simple" Class I devices will not be covered by the extension. In your case, if this is a Class I SaMD, you will need to immediately comply with the MDR.

If you do have a valid MDD certificate for your products, then you could still reap the benefits of the extension. But beware of the T&Cs..

Best of luck,
Ken

 

[iam1235]

We are in the same case as you, we will try to contact our NB in addition in our case, if you are in France, there is the new repository of interoperability that comes into force so if we are in the same case we must see if with the integration of these new features we are supposed to go to MDR. Any one can tell us what should we do ? thank you

 

[Raisin picker]

For basic class I devices (not Ir, Is, Im), you do not need a NB. So no need there to extend the transition period. Just finalize your documents (they should already be done), sign your MDR DoC, and you're good.

Sorry for being direct, but the transition period is not for lazy manufacturers, but to cover for overworked NBs.

 

[iam1235]

Software under MDD will change class to IIa according to the RDM, so to be certified it needs a NB. In this case it is necessary to see the conditions defined (for example not to have significant changes) to see if the manufacturer can benefit from the transition period.

 

[regularengineer]

Hey there,

The extension will only apply to legacy devices, i.e. those scenarios mentioned under Article 120:

• Devices that did not require NB intervention under the MDD but require under the MDR.
• Devices covered by a valid Directive CE certificate.

So "simple" Class I devices will not be covered by the extension. In your case, if this is a Class I SaMD, you will need to immediately comply with the MDR.

If you do have a valid MDD certificate for your products, then you could still reap the benefits of the extension. But beware of the T&Cs..

Best of luck,
Ken

Thanks Ken! I'm a little unclear as I understand we had a CE certificate under MDD - wouldn't this mean we are a legacy device under Article 120. That does seem to be the case based on your last line as well, but I'm also unsure about these T&Cs! It would seem that the fact this extension only applies to a certain subset of Class I's (Is/Ir/Im) may be one of those T&Cs, but just trying to be sure.

We really do not feel that the software falls under Class IIa under MDR, particularly when reviewing MDCG 2021-24 and its description of Rule 11.

 

[regularengineer]

For basic class I devices (not Ir, Is, Im), you do not need a NB. So no need there to extend the transition period. Just finalize your documents (they should already be done), sign your MDR DoC, and you're good.

Sorry for being direct, but the transition period is not for lazy manufacturers, but to cover for overworked NBs.

Thanks! And agree on the last point - we are mindful that the NBs are overworked and certainly do not intend to "exploit" this situation, but nevertheless there is an opportunity for us to continue to get our product to patients and we want to take advantage.

I want to be crystal clear though: as we have a class I MDD certificate, do we fall into the transition period?

 

[Newbie22]

Refer to Article

Hey there,

The extension will only apply to legacy devices, i.e. those scenarios mentioned under Article 120:

• Devices that did not require NB intervention under the MDD but require under the MDR.
• Devices covered by a valid Directive CE certificate.

So "simple" Class I devices will not be covered by the extension. In your case, if this is a Class I SaMD, you will need to immediately comply with the MDR.

If you do have a valid MDD certificate for your products, then you could still reap the benefits of the extension. But beware of the T&Cs..

Best of luck,
Ken

___________

I agree with Ken.

Your Class I device is not considered a legacy device, as per by Article 120 thus not covered by the extended transitional agreement.

Has the device been a Class Is or Im then Article 120 3b would have been applicable

3(b) 31 December 2028, for class IIb devices other than those covered by point (a) of this paragraph, for class IIa devices, and for class I devices placed on the market in sterile condition or having a measuring function.

Had the Class I device been up-classified under the MDR, and the DoC been written prior to 26th May 2021 then 120 (3) b would been applicable.

3b. Devices for which the conformity assessment procedure pursuant to Directive 93/42/EEC did not require the involvement of a notified body, for which the declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, may be placed on the market or put into service until 31 December 2028.

Refer to:

PE-CONS 1/23 – 2023/0005(COD)
REGULATION (EU) 2023/... OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of ... amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices

Also, when applying MDR Article 120, the risk class applicable is the risk class of the device as per Directive 93/42/EEC not MDR 2017/745

I hope the above helps

 

[KShaw]

Thanks! And agree on the last point - we are mindful that the NBs are overworked and certainly do not intend to "exploit" this situation, but nevertheless there is an opportunity for us to continue to get our product to patients and we want to take advantage.

I want to be crystal clear though: as we have a class I MDD certificate, do we fall into the transition period?

Taking into consideration that your software is not sterile, is your MDD certificate due to some measuring function your software has? Is the Notified-Body issued certificate still valid?

 

[iam1235]

Refer to Article


___________

I agree with Ken.

Your Class I device is not considered a legacy device, as per by Article 120 thus not covered by the extended transitional agreement.

Has the device been a Class Is or Im then Article 120 3b would have been applicable

3(b) 31 December 2028, for class IIb devices other than those covered by point (a) of this paragraph, for class IIa devices, and for class I devices placed on the market in sterile condition or having a measuring function.

Had the Class I device been up-classified under the MDR, and the DoC been written prior to 26th May 2021 then 120 (3) b would been applicable.

3b. Devices for which the conformity assessment procedure pursuant to Directive 93/42/EEC did not require the involvement of a notified body, for which the declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, may be placed on the market or put into service until 31 December 2028.

Refer to:

PE-CONS 1/23 – 2023/0005(COD)
REGULATION (EU) 2023/... OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of ... amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices

Also, when applying MDR Article 120, the risk class applicable is the risk class of the device as per Directive 93/42/EEC not MDR 2017/745

I hope the above helps

Hello, Thank you for these details.
If I understand correctly, self-certified medical device software according to MDD does not benefit from the transition period of 2028?