MedTech news roundup June 2025
Our June 2025 MedTech news covers the recent guidance from the MDCG on the interplay between the MDR/IVDR and the…
Congenius
Categories
- All
- Clinical
- Congenius News
- eHealth
- Fact Sheets
- MedTech News
- Operations
- Quality
- Regulatory
- Social Responsibility News
- Spotlights
- Topical Articles
- What's New
ISO 10993-1 | What’s new in the latest draft standard?
ISO 10993-1 provides the governing foundation for the biological evaluation of medical devices, explaining the fundamental requirements and general principles.…
Congenius
MedTech news roundup May 2025
Our May 2025 MedTech news covers the Swiss Federal Council’s guidelines for expanding medical devices supply, an upcoming focus campaign…
Congenius
MedTech news roundup April 2025
Our April 2025 MedTech news covers new harmonised standards from the EU Commission, updates from MedTech Europe on IVDR, MDR,…
Congenius
MedTech news roundup March 2025
Our March MedTech news covers EU-US trade tensions, the Clean Industrial Deal, updated guidance on IVD classification, and calls for…
Congenius
Chemical Analysis for Biocompatibility Assessment of Medical Devices | Essentials from the FDA draft guidance
In September 2024, the FDA published its draft guidance on “Chemical Analysis for Biocompatibility Assessment of Medical Devices” to improve…
Congenius
MedTech news roundup February 2025
Our February MedTech news covers calls from the European MedTech industry for the EU to become a full member of…
Congenius
MedTech news roundup January 2025
Our MedTech news roundup for January 2025 covers the amended IvDO, MedTech Europe’s 2024 Regulatory Survey results, the latest endorsement…
Congenius