January 2025 News Letter

Welcome to our January 2025 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.
Patient Guard News Letter January 2025, Medical Device consultancy
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Welcome to our News Letter

Happy New Year!

We are thrilled to present the latest edition of Patient Guard newsletter, your go-to source for the most current updates for medical device and in vitro diagnostic (IVD) regulations and standards.

Thank you for your continued trust and partnership. We hope you find this edition of our newsletter both informative and valuable. As always, we welcome your feedback and are here to support you in any way we can.

Kind regards,

The Patient Guard Team

Regulatory News - December 2024

EU

UK

USA

New & Updated Medical Device Standards

  • ISO 14607:2024 – Non-active surgical implants. Mammary implants. Specific requirements

  • ISO 23908:2024 – Sharps injury protection. Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration. Requirements and test methods

  • ISO 22675:2024 – Prosthetics. Testing of ankle-foot devices and foot units. Requirements and test methods

  • IEC 60601-2-39:2024 – Medical electrical equipment. – Part 2-39: Particular requirements for the basic safety and essential performance of peritoneal dialysis equipment

  • IEC 60601-2-40:2024 – Medical electrical equipment. – Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment

  • BS ISO 19045-2:2024 – Ophthalmic optics. Contact lens care products – Method for evaluating disinfecting efficacy by contact lens care products using trophozoites of Acanthamoeba species as the challenge organisms

  • BS EN ISO 11199-2:2021+A1:2024 – Assistive products for walking manipulated by both arms. Requirements and test methods – Rollators

  • BS EN IEC 60601-2-33:2024 – Medical electrical equipment – Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

  • BS EN ISO 15004-2:2024 – TC – Ophthalmic instruments. Fundamental requirements and test methods – Light hazard protection

  • BS EN ISO 14630:2024 – TC – Non-active surgical implants. General requirements

Patient Guards Medical Device Consultancy services
QMSREGS.com Medical Device Quality Assurance Templates, ISO 13485

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June 14, 2025

The European Union Medical Device Regulation (EU MDR) 2017/745 significantly reshaped the regulatory landscape for medical devices in Europe. One area that continues to cause confusion for manufacturers, distributors, and assemblers alike is the regulation of system and procedure packs. These are specific types of medical device groupings that, while not always requiring full CE marking as a new device, are still tightly regulated under Article 22 of the MDR.

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