Electromagnetic Compatibility of Medical Devices
For active medical devices CE marking, it is important to test the electromagnetic compatibility and include all the test reports as evidences in the Technical documentation. Electromagnetic Compatibility (EMC) means that device does not cause any interference by its electromagnetic environment as well as it does not emit any kind of electromagnetic interference with any other device. The EMI can cause potential malfunctioning and even threat to the life where the high-risk devices using medical environment.
For the Medical devices the harmonized standards EN 60601-1-2 and IVD devices EN 61326-2-6 are followed for performing the Electrical Safety and Electromagnetic compatibility tests. For CE marking the new EU MDR 2017/745 contains the sets of requirements for the electric safety and control of emission that the general medical devices and the Active Implantable medical devices should follow for the safety.
For an electric and electronic medical device, is it mandatory to fulfill the requirements of the EMD directive 2014/30/EU? What are documents to be included in the Technical documentation for the EMC and electrical safety?