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
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