Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi RAPS members,

The EU standardization mandate (M575 EN) does not mention DICOM standard. If DICOM standard is applicable in US which EU harmonized standard can be used for EU?


Thanks in advance

Hello Anon,

First, as has been posted in many other forum posts, there is no EU harmonised standards under the EU MDR/IVDR currently.  On-going saga which will maybe get resolved in 2030 ...

The DICOM standard is generally recognised around the world so information related is here https://www.dicomstandard.org/current/ (through NEMA).  The EU does recognise the current DICOM standard https://ec.europa.eu/eip/ageing/standards/ict-and-communication/other-ict/dicom_en.html which is important to remember DICOM applies very broadly across the healthcare industry - not just specific to medical device development or use.

The current version is PS 3.1 2021b, though you will find other references such as FDA currently recognises PS 3.1 to 3.20 - 2016.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
Emergo Group Inc
------------------------------

Original Message:
Sent: 26-Apr-2021 14:08
From: Anonymous Member
Subject: DICOM standard in EU

This message was posted by a user wishing to remain anonymous

Hi RAPS members,

The EU standardization mandate (M575 EN) does not mention DICOM standard. If DICOM standard is applicable in US which EU harmonized standard can be used for EU?


Thanks in advance

Hello,

there is also the ISO 12052 (from 2017) on DICOM.
The standard refers to the ACR NEMA standard which is the worldwide accepted standard around DICOM.

Those are the main documents to be taken into account, but as Ricard is mentioning, under the MDR there are currently no harmonized standards, not even the most obvious ones like 14971 (risk management), 62304 (Software lifecycle processes), 62366 (useabilty), ...

------------------------------
Franky Dubois
QA/RA Manager
FEops
Gent
Belgium
------------------------------

Original Message:
Sent: 27-Apr-2021 02:55
From: Richard Vincins
Subject: DICOM standard in EU

Hello Anon,

First, as has been posted in many other forum posts, there is no EU harmonised standards under the EU MDR/IVDR currently.  On-going saga which will maybe get resolved in 2030 ...

The DICOM standard is generally recognised around the world so information related is here https://www.dicomstandard.org/current/ (through NEMA).  The EU does recognise the current DICOM standard https://ec.europa.eu/eip/ageing/standards/ict-and-communication/other-ict/dicom_en.html which is important to remember DICOM applies very broadly across the healthcare industry - not just specific to medical device development or use.

The current version is PS 3.1 2021b, though you will find other references such as FDA currently recognises PS 3.1 to 3.20 - 2016.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
Emergo Group Inc

Original Message:
Sent: 26-Apr-2021 14:08
From: Anonymous Member
Subject: DICOM standard in EU

This message was posted by a user wishing to remain anonymous

Hi RAPS members,

The EU standardization mandate (M575 EN) does not mention DICOM standard. If DICOM standard is applicable in US which EU harmonized standard can be used for EU?


Thanks in advance