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Technical documentation EU Authorized representative Clinical evaluation PRRC services Risk management Notified bodies Quality management system Post-market surveillance
General medical devices and equipment In vitro diagnostics (IVD) Medical Device Software (MDSW)
CE-marking process for medical devices CE-marking process for in vitro diagnostics MDR technical documentation checklist IVDR technical documentation checklist Technical documentation checklist for MDSW PRRC under MDR or IVDR
CE-Certificate vs. EC-Certificate Basic UDI-DI (bUDI) EUDAMED registration - a brief guide Read more >>

Seamless Certification by a Notified Body


When a medical device manufacturer seeks to place their product on the EU market, the majority of products must undergo a thorough conformity assessment process conducted by a Notified Body, an independent organisation designated by an EU member state to assess the compliance of medical devices with the applicable regulations.



Streamlined communication with EU Notified Bodies will facilitate regulatory approvals for your medical devices. However, managing the interaction with EU Notified Bodies can be complex and time-consuming.

That's where we step in to assist you. We have a deep understanding of the regulatory requirements and expectations of EU NBs. We act as the bridge between your company and the NBs, streamlining the communication process and ensuring efficient interactions.

Contact us right now

We will support you during:

  • Finding a Notified Body - identifying the appropriate NB, establishing communication, and ultimately reaching a mutual agreement.
  • Assessment of Conformity - NBs evaluate the medical device to verify that it meets the safety, performance, and quality requirements specified in the MDR or IVDR.
  • Quality System Audit - NBs conduct audits of the manufacturer's quality management system to ensure it complies with the relevant standards and regulations.
  • Technical Documentation Review - NBs review the technical documentation submitted by the manufacturer, which includes details about the device's design, manufacturing processes, and clinical data.
  • Issue of Certificate - if the medical device successfully meets all applicable requirements, the NB issues a certificate, which attests that the device conforms to EU regulations and can be legally placed on the market with the CE marking.

We will guide you through the audits, ensuring a smooth and successful certification and pathway to gaining market access in the EU.

Send us an email:
info@mdrc-services.com

Or use the contact form below