Electro-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).