Informational Proposal to address MDR challenges

[Ed Panek]

Given we are a class II w/ software with MDD expiring in Sept 2023 and in round 1 of 3 of technical review, if there is no downside I think we would request the Art 97 as soon as it's available. I wonder how backlogged that request queue will be.

 

[dgrainger]

This is now out for consultation!

Feedback period
11 January 2023 - 09 March 2023 (midnight Brussels time)
European Commission - Have your say

 

[chris1price]

Thanks for keeping us up to date on this. I can't remember seeing an on-line public consultation from EU before, this is an interesting development.

in the proposal, there is a lot of of devices, but much less on IVDs. This is really all it says.

• Article 2(1) of the proposal – deletion of the ‘sell-off’ deadlines in the IVDR
This provision deletes the current ‘sell-off’ dates (25 May 2025 to 26 May 2028) in Article 110(4) IVDR. Consequently, devices placed on the market before the end of the transition period laid down in Article 110(3) IVDR can be made further available on the market without a legal time restriction.
• Article 2(2) of the proposal – adaptation of Article 112 IVDR
This provision adapts Article 112 IVDR to reflect the deletion of the ‘sell-off’ deadlines."

Can someone confirm my interpretation of this to say that if you have a valid IVD-D certificate prior to the extended transition date, the IVD does not need to meet IVD-R, ever ?

 

[dgrainger]

BTW, the consultation has been reduced to 1 week:

11 January 2023 - 18 January 2023

 

[Billy Milly]

I noticed that. A bit surprising...

 

[chris1price]

To mix metaphors, advocating against the proposal is like turkeys voting for Christmas ! I can't see anyone objecting very hard.

 

[L_O_B]

Thanks for keeping us up to date on this. I can't remember seeing an on-line public consultation from EU before, this is an interesting development.

in the proposal, there is a lot of of devices, but much less on IVDs. This is really all it says.

• Article 2(1) of the proposal – deletion of the ‘sell-off’ deadlines in the IVDR
This provision deletes the current ‘sell-off’ dates (25 May 2025 to 26 May 2028) in Article 110(4) IVDR. Consequently, devices placed on the market before the end of the transition period laid down in Article 110(3) IVDR can be made further available on the market without a legal time restriction.
• Article 2(2) of the proposal – adaptation of Article 112 IVDR
This provision adapts Article 112 IVDR to reflect the deletion of the ‘sell-off’ deadlines."

Can someone confirm my interpretation of this to say that if you have a valid IVD-D certificate prior to the extended transition date, the IVD does not need to meet IVD-R, ever ?

I am not sure how you ended up with this interpretation.

The sell-off provision (article 110(4)) was removed. That means that devices that were placed lawfully on the market (e.g. valid IVDD certificate) in the context of the transitional provisions can be made further available on the market. This results in the scenario that you (manufacturer) may sell your devices (read 'single unit') until the the end-date of the transitional provisions and anyone (distributor or importer) who makes it further available. These entities may now sell these devices without any legal time restriction.
You (manufacturer) remain with the hard cutoff date for offering your devices on your certificate or in article 110(3) respectively.

Technically, this is not 100% correct because "making available on the market" covers way more activities that just selling (see blue guide) but for this case it is sufficient.

 

[Sullen-gent]

Can anyone tell me if the delay applies to all Legacy devices or only those legacy devices that are being transitioned to EU MDR?

We wont be taking the whole range over to EU MDR but not sure if this amendment allows for another 5 years of selling devices that wont come under EU MDR.

 

[Billy Milly]

Extension is granted to devices with MDD certificate that have not been significantly changed and for which the manufacturer has signed a contract for MDR certification before a given deadline. So, short answer is no.

 

[Sullen-gent]

Extension is granted to devices with MDD certificate that have not been significantly changed and for which the manufacturer has signed a contract for MDR certification before a given deadline. So, short answer is no.

Thanks for the quick reply. Not worried about design changes or previous MDD cert.

I think the MDR contract will include a list of devices you plan to submit so am I right in thinking if devices aren't covered by the contract then they don't benefit from the extension?