Commission proposes to extend transition periods for certain IVDs, gradual roll-out of Eudamed and an information obligation in case of interruption of supply
In January 2024, the European Commission proposed to amend existing IVDR, MDR, and EUDAMED regulations.
Crème de la Crème expands services to the USA and beyond
Crème de la Crème, a leading provider of regulatory advice and support to the health and beauty cosmetics industry, is excited to announce its expansion from the European Union and the United Kingdom to the United States and beyond.
Updates on ISO 13485 for USA QSR to QSMR
On 31st January 2024, the United States Food and Drug Administrator [USFDA] published an update where the QSR – Quality System Regulation requiring CGMP will be replaced by QSMR – Quality System Management Regulation.
What Digital Health Manufacturers need to know when planning to sell in the EU
With the introduction of Medical Device Regulation [MDR] and In-Vitro Diagnostic Regulations [IVDR], the European Commission raises caution by emphasising traceability, patient safety and vigilance.
UK joins Horizon Europe under new bespoke deal
UK Government announced that the UK has joined Horizon Europe and Copernicus programmes through a new bespoke agreement with the EU.