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.

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
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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

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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)
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Patient Guard News

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

Most Popular

Cosmetics Regulations

Cosmetics Regulations are in place to ensure the safety, quality, and efficacy of products used on the skin, hair, and body. Regulations prevent the inclusion of harmful ingredients, protect consumers from potential health risks, and ensure accurate labeling and claims.

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October 2024 News Letter

Welcome to out October 2024 news letter, here we share the latest medical device regulatory news from the EU, UK and the USA as well as updated or new medical device standards that have been issued.

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UK Responsible Person (UKRP) – Medical Devices

The UKRP must provide written evidence that they have the manufacturer’s authority to act as their UK Responsible Person. Importers and distributors are not required to appoint a UK Responsible Person.

The UKRP acts on behalf of the non-UK manufacturer to carry out specified tasks in relation to the manufacturer’s obligations. As noted above, this includes registering the manufacturer’s devices with the MHRA before the devices can be placed on the UK market.

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The Biological Evaluation of Medical Devices

In healthcare, ensuring the safety and efficacy of medical devices is paramount. Patients rely on these devices for diagnosis, treatment, and improved quality of life.  Biological evaluation plays a pivotal role in determining the biological safety of these devices. Governed by international standards, most notably the ISO 10993 series, biological evaluation involves a thorough assessment of a device’s interaction with living tissues. This blog delves into the importance of biological evaluation, highlighting the critical biological endpoints outlined in ISO 10993, the significance of a robust biological evaluation plan, and the crucial role of qualified experts in this process.

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