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Draft standardisation request as regards medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746

Draft standardisation request as regards medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746

3 Comments

  1. Sam Sam June 27, 2019

    Any idea why some standards (e.g. 60601-2-16) have not been included, when they were in the original MDD harmonised standards list?

  2. Marcelo Antunes Marcelo Antunes Post author | June 27, 2019

    Yes, it seems that the idea is to do 2 requests, where the first would include “process” standards and the second, “product” standards. Older drafts that I saw were like these. In this published draft, they ended up including some product standards, but probably due to last minute discussions (I also know that some stakeholders were keen in including at least some standards in the IEC 60601 series).

    • Sam Sam June 28, 2019

      Brilliant, thanks very much. Odd and scary times

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