Are DHR and Design Dossier synonymous?

[Castaway99]

Sorry, this is not really a reply to that post, but I do not know how to start a new thread, So here goes......Is DHR and Design Dossier synonymous? Is this the document that is being referred to in EC design-examination certificate where it says that the ' design of the product was assessed and fulfills the requirements of Annex II Section 4............'

 

[MIREGMGR]

Re: How much detail in DHR (Device History Record) is too much?

The DHR is an ongoing record of manufacturing and other realization activities.

A design dossier is a compilation of documents that define the design of the product, from product initiation and definition of inputs to design validation and transfer to production, and including risk management, usability, instructions for use and related factors.

"Design dossier" usually refers to a higher-risk-class device under the EU Medical Device Directive. The similar document set for a lower-risk-class device would be its Technical File. Under US FDA regulations (which are where the term "DHR" or Device History Record comes from), the similar term would be "DMR" or Device Master Record, plus in some contexts the "DHF" or Design History File which captures aspects of the design documentation/process history preceding the finished design.

 

[BradM]

Re: DHR\ Design dossier: are they synonymous?

Castaway99,
I have moved your post to its own thread.

Let us know if you need anything!

 

[Castaway99]

Re: How much detail in DHR (Device History Record) is too much?

Thanks MIREGMGR / BradM. The explanation was very helpful and the movement too. One more question. Its about the contents of the DHR. I have a TUV Sud document which seems to focus on the technical side and not so much on the design control aspect (7.3; ISO 13485), design artifacts such as a design plan, design review are not called for in this. Also since design is an iterative process, what should be the contents of a DHR. I am attaching the TUV Sud document..........Thanks in advance

 

[Marcelo]

Re: DHR\ Design dossier: are they synonymous?

More information on the design dossier can be found here: (broken link removed)

The design dossier (and technical file) are what is called Summary Technical Documentation (STED - more on this here: https://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n011-2008-principles-safety-performance-medical-devices-080221.pdf) and are a summary of the results of the design process.

Formally, the only difference is that the design dossier has to be sent to the NB for review, whereas the technical file is evaluated during the audit.

 

[Castaway99]

Thanks Marc.

 

[esalsan]

I also find useful the NB-MED/2.5.1/Rec5 document (https://www.meddev.info/_documents/R2_5_1-5_rev4.pdf)

Hopefully still valid. On this note, shall we expect Notified Body guidance documents (regarding the content of the technical documentation) to change as a result of the proposed medical device regulations?

Cheers!

 

[MIREGMGR]

Re: How much detail in DHR (Device History Record) is too much?

One more question. Its about the contents of the DHR. I have a TUV Sud document which seems to focus on the technical side and not so much on the design control aspect (7.3; ISO 13485), design artifacts such as a design plan, design review are not called for in this. Also since design is an iterative process, what should be the contents of a DHR.

A DHR is the FDA term for a manufacturing history. It might contain the work orders that governed the production of each unit of the product you've made to date, including information on the revision levels used for each work order of every change-controlled document, data file, tool/jig/fixture and other controlled information-element or object pertaining to the process and product, along with information on specific labeling applied to those units, their QC acceptance checks and so forth.

You're asking about the design history. In the FDA realm, that's the DHF. It contains documentation of each aspect of the design process and product except the current, final process and product, which are documented in the DMR.

 

[Ronen E]

Re: How much detail in DHR (Device History Record) is too much?

that's the DHF. It contains documentation of each aspect of the design process and product except the current, final process and product, which are documented in the DMR.

In most companies I know the DHF covers all history, including reference to the current, final process and product, which are also documented / referenced in the DMR.

 

[Ronen E]

I also find useful the NB-MED/2.5.1/Rec5 document (https://www.meddev.info/_documents/R2_5_1-5_rev4.pdf)

Hopefully still valid. On this note, shall we expect Notified Body guidance documents (regarding the content of the technical documentation) to change as a result of the proposed medical device regulations?

Cheers!

This is becoming slightly

As far as I understand, "the proposed regulations" (EU) are on hold for an extended / unknown period of time, due to EU political and administrative reasons. The timeline for their finalization is uncertain, let alone their final form and contents. Even when they do materialize, it will take years before they are in full swing (consider transition periods). I don't think we'll see any related change in NB guidance documents in the next couple of years, to say the least.

Cheers,
Ronen.