Europe-CE Marking MDR / IVDR

Notified Body Selection & Application Support

Ensure a Smooth CE Marking Process with AQC

Selecting the right Notified Body (NB) is a critical step in achieving CE marking for medical devices (MD) and in vitro diagnostics (IVD) under EU MDR 2017/745 and IVDR 2017/746. At AQC, we guide manufacturers through the Notified Body selection and application process, ensuring compliance with regulatory requirements while minimizing delays and costs.

Why is Notified Body Selection Important?

Contract Manufacturers & Suppliers

Mandatory for CE Marking

Required for devices in Class Is, Im, Ir, IIa, IIb, and III (MDR) and Class B, C, and D (IVDR)

Medical Device & IVD Manufacturers

Ensures Market Access

Without an NB review, high-risk devices cannot enter the EU market

Distributors & Importers

Reduces Delays

Choosing the right Notified Body minimizes review times & rejection risks

Distributors & Importers

Regulatory Expertise

Different NBs specialize in various device categories & technologies

Our Notified Body Selection & Application Services

Notified Body Identification & Matching

  • Identify Notified Bodies designated under MDR/IVDR
  • Match the right NB based on device type, risk class & expertise
  • Evaluate NB capacity, certification timelines & fees

Pre-Application Readiness Assessment

  • Assess device classification & confirm Notified Body involvement
  • Review technical documentation & quality management system (QMS) compliance
  • Ensure readiness for Notified Body audits & assessments

Notified Body Application Support

  • Prepare & submit NB application package
  • Assist in completing Notified Body contracts & agreements
  • Provide guidance on fees, timelines & certification processes

Communication & Submission Management

  • Act as a liaison between manufacturer & Notified Body
  • Address NB queries, non-conformities, & corrective actions
  • Support in scheduling QMS audits & product assessments

Post-Application Support & Certification Assistance

  • Prepare for Notified Body audits & regulatory inspections
  • Assist with corrective actions & compliance updates
  • Provide ongoing regulatory support & certification maintenance

Key Factors in Notified Body Selection

  • Designation under MDR 2017/745 & IVDR 2017/746
  • Experience in relevant device category & classification
  • Capacity & availability (avoiding long wait times)
  • Audit & assessment timelines
  • Fees & certification costs
  • Global acceptance & recognition
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