Ensure a Smooth CE Marking Process with EUmAccess GmbH
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 EUmAccess GmbH, 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?
Mandatory for CE Marking
Required for devices in Class Is, Im, Ir, IIa, IIb, and III (MDR) and Class B, C, and D (IVDR)
Ensures Market Access
Without an NB review, high-risk devices cannot enter the EU market
Reduces Delays
Choosing the right Notified Body minimizes review times & rejection risks
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 |
Drop here a note
contact@eumaccess.com
Call us Directly
+49 621-76-44-10-101
Drop here a note
contact@eumaccess.com
Call us Directly
+49 621-76-44-10-101
EUmAccess GmbH
At EUmAccess GmbH, we specialize in providing expert regulatory and compliance solutions to businesses with a focus on the Medical Devices (MD) and In Vitro Diagnostic (IVD) sectors, we assist manufacturers in navigating the complex regulatory landscape, ensuring smooth market entry and compliance with EU directives and regulations.