IVDR Class D Diagnostics Transitional Provisions Q&A Updates
To support the diagnostics sector, the Medical Device Coordination Group (MDCG) has released an updated Q&A document regarding the transitional provisions for the certification of Class D diagnostics. This update is crucial for manufacturers and stakeholders navigating the complexities of regulatory compliance under the In Vitro Diagnostic Medical Devices Regulation (IVDR). Class D diagnostics are […]
MDCG Revises Guidance on Classification for In Vitro Diagnostics
In a move poised to reshape the regulatory landscape for in vitro diagnostics (IVDs) across Europe, the Medical Device Coordination Group (MDCG) has released new guidance on classification rules. This July 8, 2024 update is the third revision of the guidance and aims to bring clarity and consistency to the classification of IVDs, ensuring that […]
MDCG UPDATES Q&A ON IMPORTERS AND DISTRIBUTORS
The Medical Device Coordination Group (MDCG), the regulatory body that works toward ensuring the safe and effective use of medical devices in Europe, recently updated a Q&A document on how both the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) apply to importers and distributors. Under both regulations, an economic operator is defined […]
