MEDIMARK EUROPE

In the MME News of last March, we sent a warning that Annex IX of the Medical Devices Directive 93/42/EEC as amended by Directive 2007/47/EC which places a special emphasis on a new definition of a device’s time of use might lead to some reclassification of devices. The new classification guidelines MEDDEV 2. 4/1 Rev. 9 of June 2010, published 3 months after the enter in force of the amended MD directive (and not before as it should have been! ) confirm this vision.You will read below that for example, peripheral vascular catheter are considered as long term long-term surgically invasive devices in Rule 8, meaning a classification in IIb instead of IIa.The Tracheal cannulae are now in class IIb (Rule 5), etc . .