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Medtech Europe guidance – Use of Symbols to Indicate Compliance with the MDR

Use of Symbols to Indicate Compliance with the MDR

2 Comments

  1. surya surya May 14, 2019

    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.

  2. Marcelo Antunes Marcelo Antunes Post author | May 15, 2019

    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).

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