New Notified Bodies for MDR & IVDR: CNCps and NSAI strengthen EU Certification
The European certification system continues to expand with the recent designation of two new Notified Bodies (NBs):
Why is this important for medical device and IVD manufacturers?
With MDR and IVDR now fully in effect, obtaining CE certification is a top priority. The increase in Notified Bodies helps ease bottlenecks and delays, ensuring a smoother approval process.
CNCps: Expanding IVDR Certification Capacity
The Centro Nacional de Certificación de Productos Sanitarios (CNCps) has now been officially designated as Notified Body 0318 for IVDR, strengthening Spain’s role in medical device certification.
What does this mean for IVD manufacturers?
- CNCps can now certify in vitro diagnostic devices, including infectious disease tests, oncology biomarkers, and neonatal screening tools.
- This designation helps mitigate potential shortages of certified IVDs, ensuring a more efficient market supply.
- Manufacturers can submit certification applications through the CNCps platform starting March 1, 2025.
Need IVDR certification for your IVD device? Discover how we can help.
NSAI: Strengthening MDR Certification
The National Standards Authority of Ireland (NSAI) has now been officially designated as a Notified Body for MDR, further positioning Ireland as a key MedTech hub.
What does this mean for medical device manufacturers?
- NSAI will assist companies in obtaining CE certification for medical devices, focusing on quality and safety.
- The increased certification capacity supports both SMEs and multinational companies in navigating MDR requirements.
- Ireland is already a strategic MedTech hub, with over 450 companies, 60% of which are locally owned.
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