Regulatory Open Forum

We are class I (non sterile, non measuring) medical devices manufacturer and selling medical devices of one GMDN code but different models.
2-3 years ago, we decided to discontinue one of the old model and provided replacement with new model.

Few technical files such as Production description and classification rationale, GSPR, etc. still have details of our old model. 
Should I remove previous model details when I revise Production description and classification rationale, GSPR, etc. tech files or leave it like it and add new models details?

Note: 
We do provide warranty of chairs 2 years only
However, our clients still use product after 2 years by getting replacement of damaged parts.

We are not providing any expiry date so what would be TPLC in this case?

We decided to keep device master records separate for each model but few tech files such as GSPR, Applicable standard list, etc. combined (applicable to every model)

RA experts, your valuable opinion would be highly appreciated. 

Thanks - Arslan 

In this case your conformity assessment path is EU-MDR Article 52(7)(1^st sentence).

First you prepare the Annex II and the Annex III technical documentation and then prepare the Article 19 Declaration of Conformity, DoC.

As you make changes, the three documents must stay synchronized. If you discontinue a model, then that should change the Annex II, Annex III, and DoC. Retain the prior versions for the record retention period. Provide the new versions to the Authorized Representative.

So in particular, you should revise the three documents to remove the information about the old models.

Also, the EU doesn't use GMDN codes any more, so you need to add the EMDN codes. (I don't see a problem with leaving the GMDN codes in the documents.)

If the models are similar, then having them all covered by the same three documents is sensible. Similar means that are all in the same EN ISO 13485:2016/A11:2021 4.2.3 Medical Device File (because they are in the same medical device family) and have the same Basic UDI-DI.

We are class I (non sterile, non measuring) medical devices manufacturer and selling medical devices of one GMDN code but different models.
2-3 years ago, we decided to discontinue one of the old model and provided replacement with new model.

Few technical files such as Production description and classification rationale, GSPR, etc. still have details of our old model. 
Should I remove previous model details when I revise Production description and classification rationale, GSPR, etc. tech files or leave it like it and add new models details?

Note: 
We do provide warranty of chairs 2 years only
However, our clients still use product after 2 years by getting replacement of damaged parts.

We are not providing any expiry date so what would be TPLC in this case?

We decided to keep device master records separate for each model but few tech files such as GSPR, Applicable standard list, etc. combined (applicable to every model)

RA experts, your valuable opinion would be highly appreciated. 

Thanks - Arslan 

We are class I (non sterile, non measuring) medical devices manufacturer and selling medical devices of one GMDN code but different models.
2-3 years ago, we decided to discontinue one of the old model and provided replacement with new model.

Few technical files such as Production description and classification rationale, GSPR, etc. still have details of our old model. 
Should I remove previous model details when I revise Production description and classification rationale, GSPR, etc. tech files or leave it like it and add new models details?

Note: 
We do provide warranty of chairs 2 years only
However, our clients still use product after 2 years by getting replacement of damaged parts.

We are not providing any expiry date so what would be TPLC in this case?

We decided to keep device master records separate for each model but few tech files such as GSPR, Applicable standard list, etc. combined (applicable to every model)

RA experts, your valuable opinion would be highly appreciated. 

Thanks - Arslan