Medtech Europe guidance – Use of Symbols to Indicate Compliance with the MDR
More from MedTech EuropeMore posts in MedTech Europe »
- From MedtechEurope – IVDR – MDR Labelling differences: what symbols apply to IVDs
- From MedtechEurope – Implementation Status of the Medical Devices Regulation: a Call to Action
- Medtech Europe presentation – – Industry Perspective on the Implementation Status of the MDR/IVDR
- Medtech Europe – Open letter to the European Commission on the implementation and readiness status of the new Medical Device Regulation (MDR)
- MedTech Europe Statement on the Implant Files
Thanks for the info. I need a clarification here. For example if we are using infusion pumps , Infusion pumps will have Keypad buttons to operate it. In case of Start/Pause button should have an symbol or is that okay to Write on top of the button Start/Pause. Please share you knowledge Marcelo.
Hi, it really depends on what you want and what the regulatory expectations are. In general, it’s better to use symbols (in particular if you market in different countries) than language. For example, if you use the IEC 60601 series of standards, there’s a general expectation that you use symbols (and many of those are described in IEC TR 60878:2015 – Graphical symbols for electrical equipment in medical practice).