Patient Guard News
We’re planning to conduct these insightful sessions once every month, accommodating up to 4 participants per course. The best part? It’s all happening virtually via Microsoft Teams, guided by our expert Patient Guard trainer. So, if you or your colleagues are eager to deepen your understanding of EU regulations, this is your perfect opportunity. To find out more click below
Regulatory News
European Union
Here we show medical device and IVD news and updated MDCG documents issued by the EU for the month of April 2024.
EU Commission News
- A Study and dashboard on reprocessing and reuse of single-use-devices in the EU
- MDCG 2024-4 – Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 – April 2024
- Update – MDCG 2022-9 rev.1 – Summary of safety and performance template – April 2024
- MDCG 2024-5 – Guidance on the Investigator’s Brochure content – April 2024
United Kingdom
Here we show medical device and IVD news shared by the MHRA in the month of April 2024.
MHRA News
Impact of AI on the regulation of medical products
United States
Here we show medical device and IVD news shared by the FDA in the month of April 2024.
FDA News
- CDRH 2024 Innovation Report (April 2024)
- CDRH 2024 Safety Report (April 2024)
Latest Medical Device standard releases and updates
Here we show all the latest medical device and IVD standards that have been issued by BSI in the month of April 2024.
BS EN 17854:2024 – Antimicrobial wound dressings. Requirements and test method
BS ISO 5832-4:2024 – TC – Implants for surgery. Metallic materials – Cobalt-chromium-molybdenum casting alloy
BS EN ISO 5832-1:2024 – TC – Implants for surgery. Metallic materials – Wrought stainless steel
BS EN ISO 5832-7:2024 – Implants for surgery. Metallic materials – Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy
BS EN ISO 8637-2:2024 – TC – Extracorporeal systems for blood purification – Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
