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A lot of questions, acronyms and unknowns in this question that this quite the puzzle. Let's unpack: is the software separately a device? In that case it would need its own UDI. If the software forms a device with the computer, the UDI can be for the whole software plus computer device. However, ...

In addition to what Armin mentioned: probably also batteries regulation if it has a battery for uninterrupted power supply (many of these robots do). RED if the robot has a wireless interfacing capability. EMC (since MDR is not applicable EMC needs to happen separately). EUP (Energy using products) may ...

See for background to this BVMed's white paper about further development of the MDR and IVDR, section 6.1. That also describes how industry generally would propose to see this changed. https://www.bvmed.de/download/bvmed-vdgh-whitepaper-summary-future-development-of-the-mdr-and-ivdr Neither MDSAP ...

First scenario: no, because the UK is not Union. Union (as per article 1 MDR) are all EEA member states plus Turkey - these are all the countries in which the MDR applies (see the Blue Guide for detailed explanation). The UK brexited to make the UK great again without EU legislation. The Swiss called ...

Yes, as long as the PRRC is based in the Union (see the other answers with reference to the applicable MDCG guidance). So, if the manufacturer is based in the EU, then the PRRC can still be based in Norway, Iceland, Liechtenstein or Turkey - which are all Union but not EU. ------------------------------ ...