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
Facebook
X
LinkedIn

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

Most Popular

ISO 27001 Internal Audits

April 6, 2025

companies operating in regulated sectors such as medical devices, healthcare, and life sciences, protecting sensitive information—whether patient data, design documents, or clinical trial results—is not only critical for business continuity but also required under stringent regulatory obligations. This is where ISO/IEC 27001, the international standard for Information Security Management Systems (ISMS), comes into play.

Read More »

The Role of Notified Bodies in Medical Device Certification

April 5, 2025

Ensuring safety and efficacy is paramount for medical devices. Manufacturers aiming to market their products within the European Union must navigate a complex regulatory landscape. One of the most critical aspects of this process is obtaining CE marking—a declaration that a product complies with all relevant EU legislation. Central to this pathway is the involvement of Notified Bodies (NBs).

Read More »

April 2025 News Letter

April 5, 2025

Welcome to our April 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.

Read More »
patient guard
Patient Guard

Sign up to our newsletter

Be the first to hear industry news and how Patient Guard can help you.

Patient Guard Logo
Facebook-f X-twitter Instagram Linkedin-in Youtube
UK Office

Patient Guard Limited:
Lancaster House,
Amy Johnson Way,
Blackpool, Lancashire FY4 2RP

German Office

Patient Guard Europe UG:
Hauffstr. 41, 73765 Neuhausen, 
Deutschland / Germany

Quick Links
Copyright © Patient Guard | Website design and marketing by Sharp Ahead

Get the Medical Device Technical Checklist

Thank you! The checklist is now ready to download.

Download Now

Get the Medical Device Technical Checklist

Complete the form below and receive instant access.

Speak to one of our medical device consultants

For help with the checklist or other aspects of your compliance journey, please reach out to us at Patient Guard and our experts would be happy to help.

UK Office

Get the latest updates on medical device regulation

Sign up to our newsletter and we’ll deliver news and insights straight to your inbox.

Patient Guard Regulatory Affairs and Quality Assurance

Do you need support with Medical Device or IVD compliance?

We can help you!