What if the manufacturer is using software / components to which they don't have full rights themselves? Nobody builds anything "from scratch" any more, and many spaces (I don't know about medical) just don't have any open source tools to go with. If the alternatives are not entering the UK market at all, having to make a completely different, from-scratch version from a single country or pay ridiculous amounts for full copyright on every single part you use, the first option is the only ones that make sense. This has the potential of removing access to all medical devices instead of making them freely available.

@miki Fair point, but provided the manufacturer makes their codebase available, the legislation would give 3rd parties the option to seek those licences or patch around them. You can probably see that while possible, it would not be in a 3rd party's best interest to be deliberately obstructive when their client is seeking device approval. Particularly if there are competing component/software vendors that would actually like a slice of a market they are otherwise bullied out of.

@miki Either that company is still going to be running, in which case the code is licenceable, or the company is defunct, in which case the medically approved IP is now available. No doubt there will be buggering around, but I would expect that buggering around to be taken into account when a licence for the next medical device comes up for approval, and that may prejudice its chances.