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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.

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

MDCG 2021-4 Rev. 1 – Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746

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

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.

Personal Protective Equipment (PPE) Regulations

October 6, 2024

PPE Regulations are in place to ensure the safety, quality, and efficacy of products used to protect the body from hazards. Regulations ensure that personal protective equipment is fit for purpose and conforms to standards.

Cosmetics Regulations

September 27, 2024

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.