I'm also working with a number of sterile services departments in the UK.
My understanding is that all NHS departments now fall under the scope of the Directive, even if they don't put their product on the market.
The MHRA (who are responsible for implementing the Directive) say in their Medical devices Directive Bulletin 8 that all devices will have to be CE marked (ie comply with the requirements),
I'm a bit out of the loop now, but I was heavily active with all of this in the mid-90s.
Driven by a variety of factors, not least the high profile of nvCJD, the UK MDA (MHRA) was keen to ensure that all SSDs/HSDUs were being appropriately managed and run.
In short, after turning over a few stones, it was clear that it was all a bit of a horror story. Many hospitals were out of control, with several having completely unsuitable facilities and/or an inadequate supply of surgical instruments. Some of this started to hit the national media.
Only about a third of all the UK SSDs were audited by Notified Bodies, (the others being exempt), and while that third were
generally better managed, Notified Bodies didn't escape the MDA's wrath either, for having a very variable performance.
SGS actually did very well, but we all acknowledged that SSDs are.....different. If you consider the level of control required to make a sterile disposable - and then consider what you would need to take something that has been inside another person (who has by definition been ill!) - it's kinda mind-boggling.
Eventually things started to sort themselves out; the move to make all UK hospitals come under those standards presumably came out of all that previous harmonisation effort.
I'm not sure of the current situation, but I imagine the national programme is very much improved.