Comply With EU MDD Or MDR? Your Multi-Year Decision Is Beset With Hazards

Will it be better to continue compliance under the Medical Devices Directive or switch to compliance under the new Medical Devices Regulation when there is a choice? The pros and cons make it a difficult decision.

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The latest text of the EU's new Medical Devices Regulation (MDR) makes it clear that it is possible to CE-mark medical devices under the current Medical Devices Directive (MDD) for another three years. For some products CE marked under the current directives, it will then be possible to place on the market until 2024, seven years from now and put into service for additional year after that - under specific conditions.

Deciding whether this is the better option is left to

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