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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
No new or updated MDCG documents in April 2025.
UK
- Lawrence Tallon begins role as new MHRA CEO
- MHRA showcases next phase of regulatory science to bring innovative treatments to patients sooner
- Prime Minister turbocharges medical research
- First-ever MHRA analysis of UK clinical trial applications finds new opportunities to drive medical breakthroughs for patients
- Clinical Trials regulations signed into law
- Clinical investigations for medical devices
USA
No Recent Updates from the FDA – Notice stating the organisation is going through reorganisation
New & Updated Medical Device Standards
- ISO 11137-1:2025 – Sterilization of health care products. Radiation – Requirements for the development, validation and routine control of a sterilization process for medical devices
