Regulatory Open Forum

Dear Colleagues,

let me ask for your opinion about the tasks of those medical device manufacturers in the EU, that follow the US documentation system and group their documents into design history file (DHF), design master record (DMR) or device history record (DHR).

Can you imagine, that at the switch of legacy devices to the MDR, the European Union's NBs can accept TDs' contents grouped according the DHF/DMR? My understanding is, that the content of DHR is to be archived beyond the TD.

There are manufacturers of EU legacy medical devices, that structured their technical documentation (TD) according to these principles. This has been accepted by the NBs under the MDD.

The contents of DHF and DMR are scattered over the chapters of the EU TD.

My understanding is, that from legal point of view, in order to comply with the requirements of the MDR, this TD system needs to be restructured.

with best regards

Dear Colleagues,

let me ask for your opinion about the tasks of those medical device manufacturers in the EU, that follow the US documentation system and group their documents into design history file (DHF), design master record (DMR) or device history record (DHR).

Can you imagine, that at the switch of legacy devices to the MDR, the European Union's NBs can accept TDs' contents grouped according the DHF/DMR? My understanding is, that the content of DHR is to be archived beyond the TD.

There are manufacturers of EU legacy medical devices, that structured their technical documentation (TD) according to these principles. This has been accepted by the NBs under the MDD.

The contents of DHF and DMR are scattered over the chapters of the EU TD.

My understanding is, that from legal point of view, in order to comply with the requirements of the MDR, this TD system needs to be restructured.

with best regards

Dear Colleagues,

let me ask for your opinion about the tasks of those medical device manufacturers in the EU, that follow the US documentation system and group their documents into design history file (DHF), design master record (DMR) or device history record (DHR).

Can you imagine, that at the switch of legacy devices to the MDR, the European Union's NBs can accept TDs' contents grouped according the DHF/DMR? My understanding is, that the content of DHR is to be archived beyond the TD.

There are manufacturers of EU legacy medical devices, that structured their technical documentation (TD) according to these principles. This has been accepted by the NBs under the MDD.

The contents of DHF and DMR are scattered over the chapters of the EU TD.

My understanding is, that from legal point of view, in order to comply with the requirements of the MDR, this TD system needs to be restructured.

with best regards

Dear Colleagues,

let me ask for your opinion about the tasks of those medical device manufacturers in the EU, that follow the US documentation system and group their documents into design history file (DHF), design master record (DMR) or device history record (DHR).

Can you imagine, that at the switch of legacy devices to the MDR, the European Union's NBs can accept TDs' contents grouped according the DHF/DMR? My understanding is, that the content of DHR is to be archived beyond the TD.

There are manufacturers of EU legacy medical devices, that structured their technical documentation (TD) according to these principles. This has been accepted by the NBs under the MDD.

The contents of DHF and DMR are scattered over the chapters of the EU TD.

My understanding is, that from legal point of view, in order to comply with the requirements of the MDR, this TD system needs to be restructured.

with best regards

The difficulty is there are multiple systems and not harmonized. As a result, there is no overarching documentation structure that satisfies each regulatory region.

In the US, two important structures are the DHF and DMR. Each has required content. An FDA Investigator will expect to see the content organized clearly without too much "extra" stuff. Any extra stuff is subject to the inspection regardless of the regulatory region that generated the requirement.

For ISO 13485:2016 the structures are the 7.3.10 Design and development files and the 4.2.3 Medical device file. Their contents are not the same as the corresponding structures in FDA QSR; there are some things in common.

For EU-MDR the structures are in Annex I, Annex II, and Annex III. They don't align with either FDA QSR or ISO 13485:2016. However, there are some things in common.

My recommendation is that you do not try to make one Grand Structure that satisfies each regulatory region. It would be useful to have a master list of each document and where it lives to help keep the individual structures from diverging.

Dear Colleagues,

let me ask for your opinion about the tasks of those medical device manufacturers in the EU, that follow the US documentation system and group their documents into design history file (DHF), design master record (DMR) or device history record (DHR).

Can you imagine, that at the switch of legacy devices to the MDR, the European Union's NBs can accept TDs' contents grouped according the DHF/DMR? My understanding is, that the content of DHR is to be archived beyond the TD.

There are manufacturers of EU legacy medical devices, that structured their technical documentation (TD) according to these principles. This has been accepted by the NBs under the MDD.

The contents of DHF and DMR are scattered over the chapters of the EU TD.

My understanding is, that from legal point of view, in order to comply with the requirements of the MDR, this TD system needs to be restructured.

with best regards