New IVDR and Legacy Products

[QAengineer13]

With the new IVDR coming into force, I have a question pertaining to the Legacy IVD products, say if we don't place any new IVD of the legacy model , do we still need to meet all the technical requirement of the IVDR or its only for the products being sold after 2020 (implementation date) we need to meet all the IVDR requirements.

In simple word, for the legacy product already placed in the EU market, do we still need to have a new ER checklist, Clinical evidence etc... as per the IVDR, we are only going to support the already marketed product (no new manufacturing). Any thoughts ?

 

[yodon]

I was hoping that someone that could say for sure would answer but since nothing yet, I'll try to get the ball rolling.

I'm coming at this from the device side but I think it's basically the same in this regard (again, hopefully someone will correct if I'm off base).

Worse, apparently many of the IVDs on the market are getting bumped up in classification so there may be added burden than anticipated.

You should probably start working with your NB ASAP to flesh out a plan.

 

[Ronen E]

There are requirements that apply only to "Placing on the Market", while others apply to "Making Available on the Mearket" as well. Device models of which new units won't be Placed on the Market after the cut-off date will be exempt from the former, but not necessarily from the latter (Making Available = on-sales).

Please note that for devices manufactured outside the EU and imported, "Placing on the Market" is the sale from the importer to their buyer (the manufacturer's sale to the importer - where it occurs - doesn't count as Placing on the Market, unless the "importer" is the end-user).

 

[Pads38]

I am not familiar with IVD, either as IVDD or IVDR.

But this might be useful:

IVDR, IVDs and mass extinction | medicaldeviceslegal

 

[EthanLoh]

The new EU IVDR is only enforce after 26 May 2022. All IVDs (except class A, non-sterile) will be reviewed and certified by Notified Bodies. Technical file is a must for each IVD product/family. There will be new requirements too. E.g. New Common Specifications will be established for class D IVD.

The designation for notified bodes under the new EU IVDR will only take place after new EU MDR is enforced in 2020. Therefore, business as usual until 26 May 2022.

 

[Ronen E]

Therefore, business as usual until 26 May 2022.

Not exactly, if you read the post Pads38 linked to.