Electromagnetic compatibility (EMC) for medical devices

The European Medical Device Regulation (MDR) also requires electromagnetic compatibility (EMC) to be ensured in the design and manufacture of medical devices. This is given if the medical devices have a defined electromagnetic immunity and do not impair the function of other products or equipment in the intended environment.

The most important EMC standard for medical devices is IEC 60601-1-2:2014 + AMD1:2020.  It specifies the EMC requirements for medical devices and, in addition to laboratory tests, requires extensive documentation such as the creation of a test plan and report. The associated process is also closely linked to the manufacturer's risk management. If a special operating environment outside of professional medical practice (e.g. domestic environment or rescue service) is envisaged, requirements from other standards may be added.

This event will provide you with an initial overview of the key regulatory requirements you need to fulfil with regard to EMC for medical devices. The speakers will briefly explain an extract of the requirements for EMC in the regulatory environment and for testing in the laboratory.

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