ISO9001 Compliant Company seeking MDR

[Daithi Galway]

Hi there, I am working with a company who are ISO9001 but are medical device company manufacturing a Class I Device (not M, S or R). They want to self declare as MDR compliant and are collating their their technical documentation file. They have a couple of complications with respect to their QMS - their ISO9001 cert, they are exempt for Design which is performed by sister company in another EU country. Can you exclude design accountabilities in MDR 2017/745 such as the mentions in Article 10 (9), GSPR Annex I and Technical Documentation Annex II?
Thanks
Daithi

 

[Billy Milly]

If the company wants to be the legal manufacturer (with its address on the label), design cannot be excluded. In this case, design is outsourced, but still within the responsibility of the manufacturer.
TD is a bit different - preparation could be outsourced (with design), but legal manufacturer has to have it available, always.

 

[Daithi Galway]

Much appreciated Billy. "Design cannot be excluded" - is this because of Article 10 listing the minimum requirements for the QMS? Or is there another stipulation somewhere in the MDR? I am expecting some push back from the senior team.

 

[the_norwegian]

ISO 13485 is a harmonized standard under MDR. Thus, to avoid potential future complications perhaps you should consider ISO 13485 compliance instead of ISO 9001 compliance? I am not familiar with ISO 9001 but I am guessing it might also be much easier to obtain and maintain MDR compliance if you are certified according to ISO 13485.

 

[Daithi Galway]

100%, and they have taken my advice to kick off their ISO13485 transition project. It makes it much easier to defend when the notified body is onsite.
thank you!