Regulatory Open Forum

"Therefore, also in the medical devices field in the EU, choosing to use a standard or not belongs to the manufacturer, within its overall and ultimate responsibility on compliance. With the possible exceptions referred to above, it is not possible to impose the use of any specific standard, on the basis for instance of its status of harmonised European standard or of "state-of-the-art" standard, neither by national authorities in their market surveillance or vigilance activities, nor by notified bodies in the conformity assessment procedures they participate in. Actually, to be lawfully placed on the EU market, medical devices must comply with the health, safety and performance requirements of the applicable legislation, and not necessarily with the clauses of a standard. Conversely, compliance of a device must be assessed against the legal requirements that apply to it, and this may be made through compliance with the clauses of a standard (regardless of whether the standard is cited in the OJEU or not), but not necessarily, unless the manufacturer would claim compliance with the legal requirements by using a harmonised European standard cited in the OJEU thus conferring presumption of conformity. "

The exception talked about in the above paragraph is "At the same time, it is worth noting that for medical devices there are "exceptions that proves the rule" when standards can be regarded as mandatory: it is the case of symbols and identification colours that "shall conform to the harmonised standards" when harmonised standards containing indications on symbols or colour coding are available." 

Mark Swanson's priority list is even mentioned clearly in the following statement in the same exact order (as it is common sense and I've been preaching the same list order for 30+ years since the MDD started) and then talks about doing a risk assessment or gap analysis or similar as others in this thread have already mentioned.  So, it is clear that the MDCG 2021-05 should be a good way to show a Notified Body that if it is drifting that they need to line up with the times.  Some have already changed their policies about standards like NSAI but as Richard and others have mentioned it is still the reviewer you may need to battle with.  It says "in practice...the manufacturer may always choose to apply the technical solutions provided by harmonised European standards cited or not cited in the OJEU, or by non-harmonised European standards, or by any other international or national standards, or even to develop its own technical solutions, provided that it is able to demonstrate that these different or alternative non-harmonised means are adequate to comply with the legal requirements applicable to the product. Such a demonstration can be given by the manufacturer through a more in-depth risk assessment, gap analysis, etc., to be reflected in the related technical documents and reports within the prescribed conformity assessment procedures on the product.