I was addressing class 1r devices in particular only because that was the only obvious extension (when I commented I didn't consider upclassified SW). However, I think that the same approach can be generalised to the entire MDR, which represents a serious raising of the bar (theoretically), and has been explicitly, clearly and consistently, intended to do so. You may well argue that the implementation of that intention was flawed (and I'd agree), but that was the intention and the driving force (as far as I can tell), and we don't live in a perfect world...
As to "what difference two more years make" - sure... But don't forget that the MDR has been in the making for years, then there was the 3 years built-in transition, now this, and there are additional grace periods in the MDR itself. All in all, it'll soon be a decade since the PIP fiasco, which was (I think) the visible trigger that set the actual creation of the MDR in motion, and it's even longer since a vocal agreement started to form that the MDD was outdated and something serious had to be done about it.
I can't say, but there's circumstantial evidence - the fact that until now (pretty much the last minute) no extensions have been granted even though there was a lot of buzz around all sorts of issues (e.g. lack of NB capacity, lack of implementing rules, lack of official guidance documents) hindering full application on time.
I don't have personal connections within the EU commission and the likes, but I don't have a problem with trusting people like Erik even though he's not an official representative. Not as a single source; it helped me form a picture together with other indications. The opposite of "There will be absolutely no extensions" would be "We are definitely considering providing extensions as necessary" - I haven't come across anything indicating the latter, hence my intuitive conclusion that that wasn't the Union's stance.
I agree that the EU system is not characterised by a high degree of transparency.
Clearly you are not talking like a financial investor... If the competition effectively begins being culled in 2022 rather than in 2020, and the funds for gaining the resulting advantage were already invested by now, it will have an effect on the ROI.
Same goes for "pay me now" vs. "pay me later".
Let's not get carried away. At the moment "the surprise" is quite localised.
Being one of those "eager service providers who repeatedly insisted that the EC would not extend", I don't care too much about my "credibility hit" because I was always considered by some potential clients as "over cautious", anyway. As a RA consultant, you don't need a regulator to make a high-visibility U-turn to find yourself in that position, because when your client "does everything right" (as you've told them) and everything goes smoothly they are likely to conclude that all that fuss was unnecessary ("See? You made us do way too much"). It's a paradox built into the profession, and I'd guess you've had your share of that too. As for me, experience taught me that clients that only care about minimising the effort and always prefer the risky path (not "better safe than sorry") are not really long-term prospective clients, and while they do keep me on board the ride is quite rough.
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