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Medical device regulation in Europe is something of a moving target at the moment. Not for much longer though as the pencil pushers are heading us towards a PMA-mimetic system. Just as the FDA is softening its stance. We discuss.

The Eurocrats are getting ready to vote on a proposal to introduce something that looks remarkably like PMA for higher risk implantable devices. Industry representatives have picked up a few flaws in the argument supporting this regulatory sea-change, and we’re inclined to agree.

Read all about it here in our weekly View From The Med, which will also be available as a podcast on Monday.

published: June 28, 2013 in: medlatest Editorial, Regulatory

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