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Is my device a Reusable Surgical Instrument under the EU MDR(2017/745)?

Here is a table to help you identify if your device is under the definition of Reusable Surgical Instrument (and thus would require the involvement of an NB in the conformity assessment procedure and thus a valid CE certificate).

3 Comments

  1. Bertold Bohnert Bertold Bohnert October 31, 2019

    Who is issuing the CE certificate? The manufacturer or the notified body involved? And with which date starting?

  2. Marcelo Antunes Marcelo Antunes Post author | October 31, 2019

    I’m not sure I understand your question, but anyway, CE certificates are only issued by Notified Bodies, not manufacturers.

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