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.
Patient Guard Medical Device Regulatory news letter update October 2024.
Facebook
X
LinkedIn

Introduction

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 - October 2024

EU

UK

USA

New & Updated Medical Device Standards - October 2024

  • ISO 8536-13:2024 –  Infusion equipment for medical use – Graduated flow regulators for single use with fluid contact

  • BS EN ISO 7199:2024 – Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators)

  • BS EN IEC 61674:2024 – TC – Medical electrical equipment. Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging

  • 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

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

Most Popular

Medical Device Clinical Evaluation

November 20, 2024

All Medical Devices that are placed on the market in the EU and the UK must undergo Clinical Evaluation. Clinical Evaluation is a review of all the data that has been generated by the medical device manufacturer; pre-clinical, clinical and post market. The review of this data is performed to assess that the benefits of using the medical device outweigh the risks associated with using the medical device within the devices clinical intended purpose. 

Read More »

November 2024 News Letter

October 27, 2024

Welcome to our November 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.

Read More »

EU Authorised Representative

October 7, 2024

The EU Authorised Representative role for medical devices has existing since before the introduction of the Medical Device and In Vitro Diagnostic Regulations (EU MDR 2017/745 and EU IVDR 2017/746) were introduced in 2017 and was a requirement of their predecessors the medical device directives.

Since the MDR and IVDR Regulations were introduced the role of the EU Authorised Representative has become wider in scope and responsibilities.

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

Do you need support with Medical Device or IVD compliance?

We can help you!