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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
UK
- The Yellow Card scheme: guidance for healthcare professionals, patients and the public (Updated)
- Yellow Card centre launched in Northern Ireland to strengthen patient safety(Updated)
- Regulation of medical devices in Northern Ireland (Updated)
- Summer ready: MHRA issues updated guidance on medicines and medical devices during holiday season (New)
- MHRA announces proposals to improve access to world’s best medical devices for patients and to boost economic growth in Britain’s med tech sector(New)
- Trinity Biotech Premier Hb9210™ HbA1c Analyser: Risk of Positive Bias and Updates to Instructions for Use (IFU), including use as a diagnostic aid in diabetes mellitus (DSI/2025/003) (New)
- Field Safety Notices: 14 to 18 July 2025 (New)
- Consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices (Updated)
- MHRA’s2024–25 Annual Report and Accounts and Impact Report show progress on safety, innovation, and regulatory excellence (New)
- Field Safety Notices: 7 to 11 July 2025 (New)
- MHRA Performance Data (Updated)
- Medicines and Medical Devices Act 2021 – Stakeholder survey (Updated)
- Medicines and Healthcare Products Regulatory Agency Annual Report and Accounts 2024 to2025 (New)
- CLOSEDAI Airlock Phase 2 application (Updated)
- Register medical devices to place on the market (Updated)
- Clinical investigations for medical devices (Updated)
- MHRA fees(Updated)
- AIAirlock: the regulatory sandbox for AIaMD (Updated)
- Government to align with European specifications on high risk in vitro diagnostic devices to reduce regulatory burden (Updated)
- Common specification requirements for in vitro diagnostic devices (Updated)
- Field Safety Notices: 30 June to 4 July 2025 (New)
- Medical devices given exceptional use authorisations (Updated)
- Medical devices: list of UK approved bodies (Updated)
- Medical devices: Standardised format for the periodic safety update report(Updated)
USA
No updates were issued in July 2025
New & Updated Medical Device Standards
- ISO 19490:2025 – Dentistry. Sinus membrane elevator
- BS EN IEC 55011:2025 – Industrial, scientific and medical equipment. Radio-frequency disturbance characteristics. Limits and methods of measurement
- BS EN ISO 16408:2025 – Dentistry. Oral care products. Oral rinses
- BS EN IEC 60601-2-83:2020+A1:2025 – Medical electrical equipment – Particular requirements for the basic safety and essential performance of home light therapy equipment
- BS EN ISO 11980:2025 – Ophthalmic optics. Contact lenses and contact lens care products. Requirements and guidance for clinical investigations
- BS EN IEC 61847:2025 – Ultrasonics. Surgical systems. Measurement and declaration of the basic output characteristics
- BS EN ISO 18397:2025 – Dentistry. Powered scalers
- BS ISO 5834-4:2025 – Implants for surgery. Ultra-high-molecular-weight polyethylene – Oxidation index measurement method
- BS ISO 5834-1:2025 – Implants for surgery. Ultra-high-molecular-weight polyethylene – Powder form
- BS ISO 5834-3:2025 – Implants for surgery. Ultra-high-molecular-weight polyethylene – Accelerated ageing methods after gamma irradiation in air
- BS ISO 5834-5:2025 Implants for surgery. Ultra-high-molecular-weight polyethylene – Morphology assessment method
- BS EN 13726:2023 Test methods for wound dressings. Aspects of absorption, moisture vapour transmission, waterproofness and extensibility
- BS EN 1789:2020+A1:2023 – Medical vehicles and their equipment. Road ambulances
- BS EN ISO 7396-3:2025 – Medical gas pipeline systems- Proportioning units for the production of synthetic medical air
- BS EN ISO 7405:2025 – Dentistry. Evaluation of biocompatibility of medical devices used in dentistry
