May 2024 News Letter

Great news everyone! Patient Guard is thrilled to bring you fresh updates through our May 2024 newsletter. We’re super excited to share that we’ve started offering Training courses – kicking off with our inaugural course on ‘EU Medical Device Regulations 2017/745’.
May 2024 News letter from patient guard for all the latest medical device and IVD regulatory and quality assurance news.
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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
Map of the EU countries in blue with patient guards logo in the right hand corner.

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

Map of the United Kingdom (UK) in green with the words United Kingdom next to the union jack flag and patient guards logo in the top right hand corner.

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)
Map of the USA with patient guards logo in the top right hand corner.

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

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