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).
Is my device a Reusable Surgical Instrument under the EU MDR(2017/745)?
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- EU – COMMUNICATION FROM THE COMMISSION Guidelines on the adoption of Union-wide derogations for medical devices in accordance with Article 59 of Regulation (EU) 2017/745
- EU – Mandate M/565 COMMISSION IMPLEMENTING DECISION C(2020) 2532 of 15.5.2020 on a standardisation request to the CEN and the CENELEC in support of Regulation (EU) 2017/745 and Regulation (EU) 2017/746