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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
Regulatory News
EU
- The New MIR PDF 7.3.1 SB 10499 is published – Update 4 June 2025
- MDCG 2025-4 – Guidance on the safe making available of medical device software (MDSW) apps on online platforms (June 2025)
- Update MDCG 2019-11 rev.1 – Qualification and classification of software – Regulation (EU) 2017/745 and Regulation (EU) 2017/746 (June 2025)
- MDCG 2025-5 – Questions & Answers regarding performance studies of in vitro diagnostic medical devices under regulation (EU) 2017/746 (June 2025)
- MDCG 2025-6 – FAQ on Interplay between the Medical Devices Regulation & In vitro Diagnostic Medical Devices Regulation and the Artificial Intelligence Act (June2025)
UK
USA
- Cyber security in Medical Devices: Quality System Considerations and Content of Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff
- Unique Device Identifier Requirements for Combination Products: Draft Guidance for Industry
- Hernia Mesh – Package Labeling Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff
New & Updated Medical Device Standards
- IEC 63366:2025 – Product category rules for lifecycle assessment of electrical and electronic products and systems
- ISO 11980:2025 – Ophthalmic optics. Contact lenses and contact lens care products. Requirements and guidance for clinical investigations
- ISO 7405:2025 – Dentistry. Evaluation of biocompatibility of medical devices used in dentistry
- BS EN IEC 60601-2-83:2019+A1:2025 – Medical electrical equipment – Particular requirements for the basic safety and essential performance of home light therapy equipment
- PD ISO/TS 20721:2025 – TC – Implants for surgery. Absorbable implants. General guidelines and requirements for assessment of absorbable metallic implants
- BS EN ISO 80369-6:2025 – TC – Small bore connectors for liquids and gases in healthcare applications – Connectors for neural applications
- BS EN ISO 14644-5:2025 – TC – Cleanrooms and associated controlled environments – Operations
- BS EN ISO 14889:2025 – TC – Ophthalmic optics. Spectacle lenses. Fundamental requirements for uncut finished lenses
- BS EN ISO 9917-1:2025 – TC – Dentistry. Water-basedcements – Acid-base cements
- BS ISO 23317:2025 – TC – Implants for surgery.Materials. Simulated body fluid (SBF) preparation procedure and test method todetect apatite formation in SBF for initial screening of bone-contactingimplant materials
- BS EN ISO 16671:2025 – TC – Ophthalmic implants.Irrigating solutions for ophthalmic surgery
- BS EN ISO 7376:2020+A1:2025 – Anaesthetic and respiratory equipment. Laryngoscopes for tracheal intubation
- BS EN ISO 80369-2:2024 – Small-bore connectors for liquids and gases in healthcare applications – Connectors for respiratory applications
- BS EN ISO 21850-2:2025 – Dentistry. Materials for dental instruments – Polymers
- BS EN ISO 4823:2025 – Dentistry. Elastomeric impression and bite registration materials
- BS EN ISO 12609-1:2025 – TC – Eye and face protection against intense light sources used on humans and animals for cosmetic and medical applications – Specification for products
- BS EN ISO 16671:2025 – TC – Ophthalmic implants. Irrigating solutions for ophthalmic surgery
