From 19 August 2024, the European Commission opened a public consultation on common specifications for…
Updated guidance on standardisation for medical devices
In July 2024, the Medical Device Coordination Group (MDCG) updated its guidance MDCG 2021-5 on…
IVDR Joint Implementation Plan has been published!
The Medical Devices Coordination Group (MDCG) has issued a joint implementation and preparedness plan for…
MDR & IVDR: New harmonised standards
On 5 July 2023, the Official Journal of the European Union published two new harmonised…
MDR: Harmonised standards for QMS and risk management
Since May 26, 2021, the medical device sector experienced a great change. The new Regulation…
IVDR: Harmonised standards for QMS and risk management
May 26, 2022, is an important date for all stakeholders of the IVD sector. The…