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Electro-Medical Devices (EMD)

Electro Medical DevicesElectro-Medical Devices (EMD) can be used for Therapeutic (e.g., surgical instruments, lasers) or Diagnostic (e.g., imaging equipment, monitoring devices) purposes.
Stand-alone software, provided it meets the definition of a medical device, can also fit the EMD category.


Electro-Medical Devices are covered by the Medical Device Directive (MDD; 93/42/EEC) and are subject to classification rules 9 to 11, plus special rules. Manufacturers must adhere to a specific series of standards, including the IEC 60601 series, which is currently in a transition phase toward its “Third edition”, presenting some significant challenges.

Additional regulations may apply such as Euratom Directives for devices emitting ionizing radiations or the Machinery Directive (2006/42/EC).

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EN 60601 Guide

LNE G MED CE Marking IVD Medical DevicesWe provide answers to the most important questions, lighting the way through the 3rd edition for manufacturers.


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