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April 2025 News Letter

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.

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

EU

Update – MDCG 2020-16 rev.4 – Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (March 2025)

UK

USA

No Recent Updates from the FDA – Notice stating the organisation is going through reorganisation

New & Updated Medical Device Standards

ISO 8871-5:2025– Elastomeric parts for parenterals and for devices for pharmaceutical use – Functional requirements and testing
BS EN 61669:2016+A1:2025– Electroacoustics. Measurement of real-ear acoustical performance characteristics of hearing aids
BS ISO 16840-13:2021+A1:2025– Wheelchair seating – Determination of the lateral stability property of a seat cushion
BS ISO 16840-12:2021+A1:2025– Wheelchair seating – Envelopment and immersion characterization of seat cushions using a dual semi spherical indenter
BS ISO 8600-1:2025– TC – Endoscopes. Medical endoscopes and endotherapy devices – General requirements
BS EN ISO 15883-2:2025– Washer-disinfectors -Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices
BS EN IEC 80601-2-71:2025– TC – Medical electrical equipment – Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment
BS ISO 7176-14:2022+A1:2025– Wheelchairs -Power and control systems for electrically powered wheelchairs and scooters. Requirements and test methods
BS EN ISO 15883-3:2025– TC – Washer-disinfectors- Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
BS EN ISO 13402:2025– Surgical and dental hand instruments. Determination of resistance against autoclaving, corrosion and thermal exposure
BS EN ISO 5840-1:2021+A1:2025– Cardiovascular implants. Cardiac valve prostheses – General requirements
BS EN ISO 5840-2:2021+A1:2025– Cardiovascular implants. Cardiac valve prostheses – Surgically implanted heart valve substitutes
BS EN ISO 5840-3:2021+A1:2025– Cardiovascular implants. Cardiac valve prostheses – Heart valve substitutes implanted by transcatheter techniques
BS EN ISO 15883-2:2025– Washer-disinfectors -Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices
BS EN ISO 10993-4:2017+A1:2025– Biological evaluation of medical devices – Selection of tests for interactions with blood
BS EN ISO 10993-5:2009+A11:2025– Biological evaluation of medical devices – Tests for in vitro cytotoxicity

Patient Guards Medical Device Consultancy services

QMSREGS.com Medical Device Quality Assurance Templates, ISO 13485

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.

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).