A PMA By Any Other Name? Our “View From The Med” Suggests That’s What It Will Turn into

Gimme a P, Gimme an M, Gimme an A. What do you get? Well, not quite a PMA, but the end result might look mighty like it by the time it hits the streets. Not a bad thing though, and there’s lots of really sensible and even pragmatic stuff in the new device regs, especially the re-hash of notified body rules.

Medlatest’s weekly editorial, or “View From The Med” as we like to call it, features a bit of dissection work on this week’s newly announced changes to EU medical device regulations.

In essence we like the changes, but then again we’re not manufacturers or suppliers of medical devices for whom it looks like the burden of cost and time to market will step up. Anything to avoid European patients ever being referred to as guinea pigs in future must be a good thing, and by avoiding the letters P, M and A the legislators have taken the sting out of events… even though what the high risk devices will need to go through en route to market looks a little like a “P”, and “M” and an “A”.

You can read our reasoning here.

 

 

published: September 28, 2012 in: Healthcare, medlatest Editorial, Regulatory

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