It’s a possibility yes that the new regs are playing a part in the delay. Indeed even existing companies in production of medical devices are having to retro assess products already on the market to comply so it’s not just new applications feeling the pressure.
A positive is that ratcheting up compliance standards in the EU will mean less of an adjustment when trying to penetrate the US market.
https://ec.europa.eu/growth/sectors/medical-devices/new-regulations_en
Ann: CE Mark Update, page-285
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