Referencing the MDR by name in QMS SOPs

MiamiDM

Starting to get Involved
#1
When updating Quality System SOPs, whose scope covers both EU and US regs, as part of preparation for the MDR, does the MDR introduce a requirement that this EU regulation, i.e. 2017/745 is called out by name in areas that currently refer to 'regulatory requirements'?

E.g. in a procedure covering Design Control, and therefore Design Change, would text referring to the 'assessing impact on regulatory compliance' be amended to 'assessing impact on compliance with EU Regulation 2017/745'?

For me, the former more generic statement remains acceptable since the MDR is covered under the umbrella of regulatory compliance.

Appreciate thoughts on this
 
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shimonv

Trusted Information Resource
#2
Hello MiamiDM,
You will need to evaluate each SOP separately, but the guiding principle should be stay generic wherever you can.
I wouldn't change the wording inside the design control procedure.
I would add information about MDR in the quality manual, and mention it in the "Referenced Documents" section of SOPs that calls for communication with regulatory authorities, like Vigilance procedure.

Shimon
 
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