New Notified Bodies for MDR & IVDR: CNCps and NSAI strengthen EU Certification
Written by: Manuel Mateos CEO and Regulatory Affairs Director, CMC Medical Devices & Drugs S.L.
The European certification system continues to expand with the recent designation of two new Notified Bodies (NBs):
- CNCps (Spain) – Now designated for IVDR (EU Regulation 2017/746), increasing certification capacity for in vitro diagnostic devices.
- NSAI (Ireland) – Becomes the 11th NB worldwide for MDR (EU Regulation 2017/745) certification, reinforcing market access for MedTech companies.
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.
Need MDR certification for your medical device? Let us guide you.
Frequently Asked Questions (FAQs)
1. What is a Notified Body (NB)?
A Notified Body (NB) is an organization designated by an EU member state to assess the conformity of certain products, including medical devices and IVDs, to EU regulations. They play a crucial role in the CE certification process.
2. What are the differences between MDR and IVDR?
The MDR (Medical Device Regulation) applies to medical devices, while the IVDR (In Vitro Diagnostic Regulation) applies specifically to IVDs. Both regulations ensure that devices meet the necessary safety, quality, and performance standards before entering the market.
3. How does the new designation of CNCps impact IVD manufacturers?
The designation of CNCps as a Notified Body for IVDR certification increases capacity for IVD certification, reducing delays and providing greater access to the market for manufacturers of in vitro diagnostic devices.
4. What benefits does NSAI’s designation bring to medical device manufacturers?
NSAI’s designation as a Notified Body for MDR certification strengthens Ireland’s role as a MedTech hub and expands certification capacity, benefiting both SMEs and large companies navigating the EU’s stringent regulatory requirements.
5. When can I start submitting applications for IVDR certification through CNCps?
You can begin submitting applications for IVDR certification through CNCps starting March 1, 2025.
6. How do I apply for MDR or IVDR certification?
For MDR or IVDR certification, you can apply directly through the designated Notified Bodies like CNCps or NSAI. For expert guidance, reach out to our consultancy services.
7. How does the increase in Notified Bodies help ease delays in certification?
The increase in Notified Bodies allows for a greater number of assessments, reducing bottlenecks and accelerating the overall approval process for medical devices and IVDs, ensuring manufacturers can access the market more efficiently.
Looking for expert MDR or IVDR certification support? Contact us for a consultation!
