Transition Time for Self Declared IVDs

[TroutBrook]

Hi all,

I've been reviewing the latest rev to IVD reg yesterday and was unclear on transitional provisions for self declared IVDs. We have a number of IVD's that were self declared but now have to go through a notified body to due to new classification rules.

Article 87(3a) states:

"Devices which were lawfully placed on the market pursuant to Directive 98/79/EC prior to the date referred to in Article 90(2) may continue to be made available on the market or put into service until three years after that date."

Article 90(2) states:

"It shall apply from (5 years after entry into force)".

So the way I'm reading this is our IVD's can be legally marketed without the notified body approval for 8 years after it's been published before they'd need to have been certified by a notified body. That seems like a long time. Am I reading this right? Appreciate any insights from my fellow Covers.

Thanks
TroutBrook

 

[pkost]

It appears to me that you are right, I suspect that this is because of the monumental shift in regulation of IVDs. It will probably take that long for NB's to transition all the products over.

I also think (and my line of thinking on this is a bit weak) that if you make any changes to the device it could only be done within the constraints of the new regulation i.e. no longer self declared.

If I were you I would start planning the transition as soon as the text is finalised and transition your products as soon as possible

 

[TroutBrook]

Thanks pkost. Absolutely agree that we need to start transition ASAP. 8 years may sound long but considering the funnel they've created getting in line early is going to be critical to ensuring uninterrupted supply. Just not enough notified bodies and too many products to certify.

 

[Ronen E]

Hi all,

I've been reviewing the latest rev to IVD reg yesterday and was unclear on transitional provisions for self declared IVDs. We have a number of IVD's that were self declared but now have to go through a notified body to due to new classification rules.

Article 87(3a) states:

"Devices which were lawfully placed on the market pursuant to Directive 98/79/EC prior to the date referred to in Article 90(2) may continue to be made available on the market or put into service until three years after that date."

Article 90(2) states:

"It shall apply from (5 years after entry into force)".

So the way I'm reading this is our IVD's can be legally marketed without the notified body approval for 8 years after it's been published before they'd need to have been certified by a notified body. That seems like a long time. Am I reading this right? Appreciate any insights from my fellow Covers.

Thanks
TroutBrook

Please note the subtleties. The phrase you quoted applies to devices placed on the market prior to the article 90(2) date, ie for which the first sale in the EU has already occurred. Those devices can then be on-sold (made available on the market) for additional 3 years. Devices which will be first sold in the EU after the article 90(2) will not benefit from that extension, so apparently in order to continue to sell new devices you will have to transition by the article 90(2) date.

All the above is subject to finalisation of the regulation (has not yet occurred). I have also only commented on the text you quoted, I haven't properly studied the new IVDR text yet.

Cheers,
Ronen.