SGS Belgium designated as IVDR Notified Body: What it means for IVD manufacturers
A new designation strengthening EU capacity for IVDR conformity assessments
On April 23, 2025, the European Commission officially designated SGS Belgium NV as a Notified Body (NB 1639) under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
This designation marks a key development for the IVD industry and for manufacturers seeking a smoother path to CE marking.
Why the designation of SGS Belgium is a strategic milestone for IVD manufacturers
1. A broader network of Notified Bodies helps ease the regulatory load
The implementation of IVDR has significantly increased the demand for conformity assessments, resulting in certification delays and pressure on existing Notified Bodies.
The entry of SGS Belgium into the system offers manufacturers an additional, credible route to CE marking, helping streamline processes and reduce regulatory congestion.
2. A cross-market approach with recognized status in the EU and UK
SGS Belgium’s recognition for both CE and UKCA assessments allows manufacturers to better align their certification timelines across both markets, especially when integrated into a broader regulatory strategy tailored to their specific needs.
A strategic opportunity for IVD manufacturers
If you are a manufacturer of in vitro diagnostic medical devices, this update could:
- Simplify your IVDR certification planning
- Help you choose from a wider pool of Notified Bodies based on timelines, availability, and expertise
- Provide greater flexibility in your EU market access strategy
A positive step forward for IVDR compliance
The designation of SGS Belgium as a Notified Body is a welcome development for the sector.
Increasing the number of designated bodies strengthens the European regulatory system and provides crucial support for manufacturers navigating this complex transition.
IVDR: a demanding framework that calls for informed decisions
IVDR compliance is not just a technical exercise.
From determining the correct classification of your device to selecting the most appropriate Notified Body, every decision can influence your timelines and documentation requirements.
In a constantly evolving regulatory landscape, with limited availability across Notified Bodies, having targeted, reliable guidance can make the difference between a clear path and a process slowed down by unexpected hurdles.
Discover how we can support your IVDR strategy by aligning regulatory steps with your product and market objectives.
