March 2025 News Letter

Welcome to our March 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 Guards March 2025 News Letter - Medical Device Regulatory Affairs and Quality Assurance updates
Facebook
X
LinkedIn

Welcome to our News Letter

Hello,

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 - From March 2025

EU

UK

USA

  • No Recent Updates from the FDA

New & Updated Medical Device Standards

  • IEC 60601-2-68:2025 – Medical electrical equipment – Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
  • BS EN IEC 60601-2-39:2025 – TC – Medical electrical equipment – Particular requirements for the basic safety and essential performance of peritoneal dialysis equipment
  • BS ISO 18190:2025 – TC – Anaesthetic and respiratory equipment. General requirements for airway devices and related equipment
  • IEC 60601-2-16:2025 – applies to the BASICSAFETY and ESSENTIAL PERFORMANCE of HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as HAEMODIALYSIS EQUIPMENT
  • BS EN 13795-1:2025 – Surgical clothing and drapes. Requirements and test methods – Surgical drapes and gowns
Patient Guards Medical Device Consultancy services
QMSREGS.com Medical Device Quality Assurance Templates, ISO 13485

Most Popular

Top 5 Quality Management System Failures to Prevent

January 26, 2026

Even the most sophisticated medical device companies can stumble when their quality management system (QMS) fails. When that happens, it’s rarely a minor inconvenience – it is more often a chain reaction of recalls, warning letters, certificate suspensions, and huge remediation bills.

Read More »

CE Marking vs UKCA: 2026 Guide for Manufacturers

January 18, 2026

Post-Brexit, many medical device manufacturers are still navigating the split between CE marking and the UKCA mark — and the rules keep evolving. As the MHRA advances its “future regime” for medical devices, regulatory teams face the ongoing challenge of complying with both EU MDR obligations and the UK’s own UK MDR 2002 (as amended) framework.

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.

Speak to one of our regulatory experts

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 Medical Device Technical Checklist

Thank you! The checklist is now ready to download.

Download Now

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

Do you need support with Medical Device or IVD compliance?

We can help you!