The Medical Device Directive is an EU document (or set of documents). I believe that the idea behind it is to facilitate the free movement of new medical devices within the member states of the European Union; in other words, the EU market. I could be wrong, but I don't think it mentions maintenance very much.

Now I'm wondering - how come kit made outside of the EU - USA, China, Israel et al - gets a free ride (CE marked, and all the rest)? think

Do we suppose that all medical kit has to undergo Type Testing before being released into the EU market? Or is it just a question of paperwork, and (or) the payment of extra tariffs? After all, the FDA are already pretty tough on new kit coming into the US market - "equal to, or better than" (probably the latter) the EU, I would have thought.


If you don't inspect ... don't expect.