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)?
More from Medical Device Regulation MDRMore posts in Medical Device Regulation MDR »
- EU – Guidance – Clinical evaluation assessment report template
- EU – Team NB position statement on the requirements for the EU MDR/IVDR Notified Body Partners under the Technical Cooperation Program on Exchange of Medical Device Quality Management System Regulation and ISO 13485 Audit Reports (TCP III)
- UK – MHRA – Medical Device “Certificates of Compliance” / “Attestation of Conformity” have no legal standing under MDR
- 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
Who is issuing the CE certificate? The manufacturer or the notified body involved? And with which date starting?
I’m not sure I understand your question, but anyway, CE certificates are only issued by Notified Bodies, not manufacturers.
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