Medical Device News JULY 2025 Regulatory Update
Medboard: https://www.medboard.com/
EUROPE
- new eIFU rules – Let’s save some paper print: https://eur-lex.europa.eu/eli/reg_impl/2025/1234/oj
- MDR + IVDR + AI Act = MDCG 2025-6 – Any other legislation to add?: https://health.ec.europa.eu/document/download/b78a17d7-e3cd-4943-851d-e02a2f22bbb4_en?filename=mdcg_2025-6_en.pdf
- MDCG 2025-5: IVDR Performance Study – Masterclass to understand Performance Study: https://health.ec.europa.eu/document/download/f22f559b-dee5-43b4-9595-3ccdcca9f7ad_en?filename=mdcg_2025-5_en.pdf
- Team-NB. Software Qualification (IVDR) clarification – Translation of the MDCG 2019-11: https://www.team-nb.org/wp-content/uploads/2025/06/Team-NB-PositionPaper-Software-Qualification-under-the-IVDR-V2-20250627.pdf
- CECP: Mechanical Respiratory – Result is not good: https://health.ec.europa.eu/document/download/80f2432d-a9da-48ae-8ebb-0054b4922033_en?filename=cecp-2025-0000232089_opinion_en.pdf
- MDCG 2025-4 Software delivered with Online Platforms – Are your apps conform: https://health.ec.europa.eu/document/download/ec9b0f40-7f82-43a7-b833-ebd45b772eae_en?filename=mdcg_2025-4_en.pdf
- PROJECT NAME: COMBINE – Clinical Trials with Medicine and IVDs: https://ec.europa.eu/newsroom/sante/newsletter-archives/64447
UK
- UK PMS mandatory since June 16th, 2025 – Learning starts: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements#full-publication-update-history
- Press Release: https://www.gov.uk/government/news/first-major-overhaul-of-medical-device-regulation-comes-into-force-across-great-britain
- Periodic Safety Update Report: https://www.gov.uk/government/publications/medical-devices-periodic-safety-update-report-psur
- Example of reportable incidents: https://www.gov.uk/government/publications/medical-devices-examples-of-reportable-incidents
- MORE Guide update: https://assets.publishing.service.gov.uk/media/6847fc9c944a600f13bcb852/User_Reference_Guide___MORE_Incident_Submissions.pdf
- Document for implementation of Data: https://www.gov.uk/government/publications/documentation-for-implementation-of-data-requirements-under-the-new-post-marketing-surveillance-regulations
ROW
- USA
- UDI for combination products – What are the rules?: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/unique-device-identifier-requirements-combination-products
- Conducting Remote Reg Assessment – SQuestion and Answers: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/conducting-remote-regulatory-assessments-questions-and-answers
- Transfer of Premarket Notification (510k) – Questions & Answers: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/transfer-premarket-notification-510k-clearance-questions-and-answers
- CANADA
- Canada is cancelling all MDELs – Only if you don’t confirm the Annual License Review: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/cancellation-non-compliance-annual-review-requirements-2025.html
- Saudi Arabia
- SFDA Webinar: Risk Management File – July 8th, 2025 10 AM Saudi Time: https://www.sfda.gov.sa/en/workshop/3868398
Podcast
- Episode 340 – Software as a Medical Device: Beginner’s guide to Testing and Validation: https://podcast.easymedicaldevice.com/340-2/
- Episode 341 – Notified Bodies raise concern on Risk Grading: https://podcast.easymedicaldevice.com/341-2/
- Episode 342: From Zero to One: SaaS Founder’s First Five Years: https://podcast.easymedicaldevice.com/342-2/
