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Classification And Equivalence Guidances Published For MDR’s Non-Medical Devices

 
• By Amanda Maxwell

The EU is putting more flesh on the bones of the requirements for Annex XVI products as two guidances are issued in quick succession.

Closeup of young woman receiving filler injection in lips
• Source: Pixel-shot / Alamy Stock Photo

The European Commission has published two new guidance documents relating to Annex XVI products. These are products with no intended medical purpose that generally offer aesthetic or well-being benefits. Examples are dermal fillers, contact lenses, and equipment intended to reduce, remove or destroy body fat.

Annex XVI products are regulated in the context of the Medical Device Regulation (MDR) because they are used on or in the

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More from Geography

FDA Announces Classifications On 8 Device Types

 
• By Elizabeth Orr

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