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Static Mattresses

With the plethora of support surfaces on the market for patients with, or at risk of pressure ulceration, and the endless demands to work within budgetary constraints, it is little wonder that there may be a lack of awareness around what classification of certain medical devices actually means.

Why is it important to understand the variations between Class I and IIa medical devices?

Class I medical device classification products aren't required to be audited by an independent body; the type of product is non-invasive equipment such as pressure-relieving devices, bed frames, walking frames and stethoscopes.

Class IIa medical device classification products do require an audit by an indepedent notified body and the type of product includes active devices designed to administer or exchange energy, including pressure-relieving devices, invasive devices and dressings.

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