I would appreciate some insights regarding the new EU MDR's requirement for a harmonized standard for the quality management system. We currently have an approved product in the EU market and our AR had told us that ISO 9001 compliance was sufficient in regards to addressing the quality system requirements; in parallel we were told that IEC 62304:2006 (Medical Device Software Lifecycle Processes) applied since our Class I medical device is software. As part of implementing IEC 62304 we also implemented EU ISO 14971:2012 (I point this out because I understand that risk management is a big requirement in ISO 13485).
However everything I've read in the last couple of years always points to ISO 13485 for EU CE marking and I've always wondered why our AR pointed to ISO 9001 (note that I am not fully up to speed on the differences between ISO 9001 and ISO 13485).
Reading through various documentation and whitepapers on the new MDR, I found the following excerpt that is making wonder even more if ISO 13485 is what we should be complying to for EU:
"General Safety and Performance Requirements, currently known as the Essential Requirements, require conformity with the generally acknowledged state-of-the-art technology, which would include any harmonized standard used. This means that ISO 13485:2016 is now the harmonized standard and has become the new state of the art."
I would appreciate feedback regarding the use of ISO 9001:2015 as the 'harmonized standard' used for a QMS to comply with the new MDR.
However everything I've read in the last couple of years always points to ISO 13485 for EU CE marking and I've always wondered why our AR pointed to ISO 9001 (note that I am not fully up to speed on the differences between ISO 9001 and ISO 13485).
Reading through various documentation and whitepapers on the new MDR, I found the following excerpt that is making wonder even more if ISO 13485 is what we should be complying to for EU:
"General Safety and Performance Requirements, currently known as the Essential Requirements, require conformity with the generally acknowledged state-of-the-art technology, which would include any harmonized standard used. This means that ISO 13485:2016 is now the harmonized standard and has become the new state of the art."
I would appreciate feedback regarding the use of ISO 9001:2015 as the 'harmonized standard' used for a QMS to comply with the new MDR.
