MDD Certification Validity after May 2020

[dr1vn]

We have a device that is Class I-sterile under the MDD. Our cert under the MDD has an expiry date of May-2024. My understanding is that we have to then transition to the MDR before the cert runs out in 2024. Until the cert expires, we can continue to sell product into the EU.This gives a little more breathing room for us than most folks I believe.

I have already checked that our device classification does not change under the new EU MDR. Are there any other pebbles that can trip us up on the road to May-2024?

 

[François]

I don't know if it will be a great issue for your product but for us it is,

Article 120 transitionals provisions:
"By way of derogation from Article 5 of this Regulation, a device with a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and which is valid by virtue of paragraph 2 of this Article may only be placed on the market or put into service provided that from the date of application of this Regulation it continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose"

The Notify body GMED has published a guidance about what they consider as a significant change. FREE : Guidance document for the interpretation of significant changes in the framework of article 120: “Transitional provisions” of Regulation (EU) 2017/745 - GMED

 

[dr1vn]

I don't know if it will be a great issue for your product but for us it is,

...provided there are no significant changes in the design and intended purpose"

Yes! This is exactly what I was looking for. I did not consider significant changes and now that I've read through the guidance doc you provided I can see how that may trip us up before May-2024. Something to watch out for and adapt to.

Thanks!

 

[Marcelo]

Also, please note that what is a significant change in this case needs to be discussed with your NB (and I suggest discussing it very seriously and quickly), but if they follow the NBOG document on changes, even changes that are outside your control (for example, the need to change a supplier because the supplier got out of the market) will make you loose your certificate.

 

[twanmul]

It is also important that you also update your post market surveillance, vigilance and some other activities on or prior to the date of application to comply with the Regulations if you are looking to utilise the transitional arrangements as per Article 120:

..."and provided there are no significant changes in the design and intended purpose. However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives."

This also applies to IVD medical devices, just the transitional arrangements timelines are different.

 

[Belen Sanchez]

Hi, My situation is that the CE certificate (devices class IIa) expires on the 18th May, 2020 and the new MDR comes into force 2 days later. Do you know if it is posible to get a extension of our certificate? My Notified Body doesn't reply to me.

Thanks a lot

 

[twanmul]

I take it by "CE certificate" you mean your certificate issued by your NB regarding the directive rather than ISO 13485 certificate. If that's the case, you'll either need your re-assessment against the existing directive or an initial assessment against the new regulation (should you be ready to) on or prior to the 18th May.
To be clear, the MDR entered into force on 26th May 2017, its Date of Application is 26th May 2020.
If I were you, I would persist with the Notified Body until you get a response and some assurance of whether you're able to be assessed at the right time.

 

[Belen Sanchez]

Thanks, yes, it is the CE certificate issued by our NB. Our ISO 13485 Certificate expires on the 22th May, 2022.
OK, the "problem" is that our NB is missing and doesn't reply to us, it still in phase of certification under MDR.

 

[Watchcat]

Belen, no, it isn't possible, because your NB won't reply to you. It might have been possible if you had asked them 6 months ago, and probably if you'd asked them last year, and almost certainly if you'd asked them in 2017. But now NBs don't have time for MDD extension requests. (Many set hard deadlines for these requests, the latest with which I am familiar was last month.)

I will caution you that, if you keep looking, you might find an NB that will reply to you, and even agree to extend your MDD certificate. This doesn't necessarily mean that they will have the time to do it, so this may only be the difference between an NB that isn't going to take the time to say no, and one that will say yes, with the outcome (no MDD extension) the same in the end. This is not to say don't look, but to look with eyes wide open.

I think some NBs that don't get MDR certification might eventually turn back to clients who have MDD certificates expiring, and try to soak the last little bit of revenue out of them before closing up shop, but so far it seems that the few that learned they were not going to get MDR designation decided to throw in the towel altogether, leaving their MDD clients high and dry.

 

[Belen Sanchez]

Ups¡ yes, the situation is complicated.
I want to start the transition of our CE certificate under MDD to MDR, but I supose that the NB can't reply until getting its acreditation.