--- title: Regulatory Affairs Advance | Regulatory Update description: Regulatory Update | To be noticed Medical Device Regulatory Affairs updates and discussions from leaders in the field. --- [Skip to content](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-update#main-content) # Blog [![](https://blog.arazygroup.com/hubfs/Urgent%20IVDR%20Deadline%20Graphic%20with%20Calendar%20(1080%20x%201350%20px)%20(6).png)](https://blog.arazygroup.com/regulatory-affairs-advance/eu-ivdr-26-september-2026-deadline-for-class-c-ivds) [Regulatory Affairs](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-affairs), [Regulatory Update](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-update), [RegTechAI](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regtechai) ## [EU IVDR: 26 September 2026 Deadline for Class C IVDs](https://blog.arazygroup.com/regulatory-affairs-advance/eu-ivdr-26-september-2026-deadline-for-class-c-ivds) [Miki Melech](https://blog.arazygroup.com/regulatory-affairs-advance/author/miki-melech) Sep 1, 2026, 10:09:31 AM Manufacturers of certain legacy Class C IVDs must have a written agreement with a Notified Body in p... [Read more](https://blog.arazygroup.com/regulatory-affairs-advance/eu-ivdr-26-september-2026-deadline-for-class-c-ivds) [![](https://blog.arazygroup.com/hubfs/regtalk-linkedin-hero-v2.jpg)](https://blog.arazygroup.com/regulatory-affairs-advance/the-unperfect-perfect-ai-regulatory-information-report) [Regulatory Affairs](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-affairs), [Regulatory Update](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-update), [RegTechAI](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regtechai) ## [AI Drafts. Humans Decide.](https://blog.arazygroup.com/regulatory-affairs-advance/the-unperfect-perfect-ai-regulatory-information-report) [Benjamin Arazy](https://blog.arazygroup.com/regulatory-affairs-advance/author/benjamin-arazy) Jun 3, 2026, 1:45:29 PM For the past several weeks I've been running a quiet experiment. Every Sunday at 6 PM Eastern, an AI... [Read more](https://blog.arazygroup.com/regulatory-affairs-advance/the-unperfect-perfect-ai-regulatory-information-report) [![](https://blog.arazygroup.com/hubfs/ChatGPT%20Image%20May%204%2c%202026%2c%2001_18_38%20PM%20(1).png)](https://blog.arazygroup.com/regulatory-affairs-advance/perplexity-vs-claude-for-regulatory-affairs) [Regulatory Affairs](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-affairs), [Regulatory Update](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-update), [RegTechAI](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regtechai) ## [Perplexity vs Claude for Regulatory Affairs](https://blog.arazygroup.com/regulatory-affairs-advance/perplexity-vs-claude-for-regulatory-affairs) [Benjamin Arazy](https://blog.arazygroup.com/regulatory-affairs-advance/author/benjamin-arazy) May 4, 2026, 11:34:12 AM When to Use Each (and When to Combine Them) AI tools are now standard in regulatory affairs, but the... [Read more](https://blog.arazygroup.com/regulatory-affairs-advance/perplexity-vs-claude-for-regulatory-affairs) [![](https://blog.arazygroup.com/hubfs/Due-Date.png)](https://blog.arazygroup.com/regulatory-affairs-advance/how-ai-is-changing-obstetrics-ultrasound-ais-delivery-date-tool) [Regulatory Affairs](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-affairs), [Regulatory Update](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-update), [RegTechAI](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regtechai) ## [How AI Is Changing Obstetrics: Ultrasound AI’s Delivery Date Tool](https://blog.arazygroup.com/regulatory-affairs-advance/how-ai-is-changing-obstetrics-ultrasound-ais-delivery-date-tool) [Benjamin Arazy](https://blog.arazygroup.com/regulatory-affairs-advance/author/benjamin-arazy) Mar 3, 2026, 2:39:10 PM Predicting a baby’s arrival has always been part science, part estimation. Even with ultrasound imag... [Read more](https://blog.arazygroup.com/regulatory-affairs-advance/how-ai-is-changing-obstetrics-ultrasound-ais-delivery-date-tool) [![](https://blog.arazygroup.com/hubfs/Build-Once.-Scale-Everywhere.png)](https://blog.arazygroup.com/regulatory-affairs-advance/12-month-ai-roadmap-for-a-3-person-ra-team) [Regulatory Affairs](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-affairs), [Regulatory Update](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-update), [RegTechAI](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regtechai) ## [12-Month AI Roadmap for a 3-Person RA Team](https://blog.arazygroup.com/regulatory-affairs-advance/12-month-ai-roadmap-for-a-3-person-ra-team) [Benjamin Arazy](https://blog.arazygroup.com/regulatory-affairs-advance/author/benjamin-arazy) Dec 17, 2025, 3:47:57 PM A straightforward plan for teams that want real progress, not another “AI experiment.” [Read more](https://blog.arazygroup.com/regulatory-affairs-advance/12-month-ai-roadmap-for-a-3-person-ra-team) [![](https://blog.arazygroup.com/hubfs/Mastering-Regulatory-Compliance-Insights-from-Singapores-Good-Submission-Practice-Workshop-2024-Arazy-Group.png)](https://blog.arazygroup.com/regulatory-affairs-advance/regulatory-update-singapore) [Regulatory Affairs](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-affairs), [Regulatory Update](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-update) ## [Regulatory Update: Singapore](https://blog.arazygroup.com/regulatory-affairs-advance/regulatory-update-singapore) [Arazy Group](https://blog.arazygroup.com/regulatory-affairs-advance/author/arazy-group) Dec 9, 2024, 4:07:41 PM Mastering Regulatory Compliance: Insights from Singapore’s Good Submission Practice Workshop 2024 Si... [Read more](https://blog.arazygroup.com/regulatory-affairs-advance/regulatory-update-singapore) [![](https://blog.arazygroup.com/hubfs/Beige%20Brown%20Thank%20You%20for%20Watching%20fashion%20and%20beauty%20(1920%20x%201080%20px)-1.png)](https://blog.arazygroup.com/regulatory-affairs-advance/how-an-eu-authorized-rep-can-boost-your-medtech-success) [Regulatory Affairs](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-affairs), [Medtech](https://blog.arazygroup.com/regulatory-affairs-advance/tag/medtech), [Clinical Evalutation](https://blog.arazygroup.com/regulatory-affairs-advance/tag/clinical-evalutation), [Regulatory Update](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-update), [Medical Device Regulation](https://blog.arazygroup.com/regulatory-affairs-advance/tag/medical-device-regulation), [EU Authorized Representative](https://blog.arazygroup.com/regulatory-affairs-advance/tag/eu-authorized-representative) ## [How an EU Authorized Rep Can Boost Your MedTech Success](https://blog.arazygroup.com/regulatory-affairs-advance/how-an-eu-authorized-rep-can-boost-your-medtech-success) [Regulatory Rockstar](https://blog.arazygroup.com/regulatory-affairs-advance/author/regulatory-rockstar) Nov 14, 2024, 11:49:48 AM Exploring the complex landscape of EU regulations for medical devices and in-vitro diagnostic device... [Read more](https://blog.arazygroup.com/regulatory-affairs-advance/how-an-eu-authorized-rep-can-boost-your-medtech-success) [![](https://blog.arazygroup.com/hubfs/imgpsh_fullsize_anim-1-1.jpg)](https://blog.arazygroup.com/regulatory-affairs-advance/regulatory-update-malaysia-3) [Regulatory Affairs](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-affairs), [Regulatory Update](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-update) ## [Regulatory Update: Malaysia](https://blog.arazygroup.com/regulatory-affairs-advance/regulatory-update-malaysia-3) [Arazy Group](https://blog.arazygroup.com/regulatory-affairs-advance/author/arazy-group) Sep 3, 2024, 2:35:12 PM Malaysia's Medical Device Authority (MDA) has just released an important regulatory update that coul... [Read more](https://blog.arazygroup.com/regulatory-affairs-advance/regulatory-update-malaysia-3) [![](https://blog.arazygroup.com/hubfs/China-1.jpg)](https://blog.arazygroup.com/regulatory-affairs-advance/cmde-releases-key-guidelines-for-clinical-evaluation-of-medical-devices) [Regulatory Affairs](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-affairs), [Regulatory Update](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-update) ## [CMDE Releases Key Guidelines for Clinical Evaluation of Medical Devices](https://blog.arazygroup.com/regulatory-affairs-advance/cmde-releases-key-guidelines-for-clinical-evaluation-of-medical-devices) [Arazy Group](https://blog.arazygroup.com/regulatory-affairs-advance/author/arazy-group) May 13, 2024, 10:57:19 AM On March 18, 2024, the Center for Medical Device Evaluation (CMDE) released an important Notice that... [Read more](https://blog.arazygroup.com/regulatory-affairs-advance/cmde-releases-key-guidelines-for-clinical-evaluation-of-medical-devices) [![](https://blog.arazygroup.com/hubfs/Brazil-1.jpg)](https://blog.arazygroup.com/regulatory-affairs-advance/brazils-anvisa-to-recognize-selected-overseas-approvals) [Regulatory Update](https://blog.arazygroup.com/regulatory-affairs-advance/tag/regulatory-update) ## [Brazil’s ANVISA to Recognize Selected Overseas Approvals](https://blog.arazygroup.com/regulatory-affairs-advance/brazils-anvisa-to-recognize-selected-overseas-approvals) [Arazy Group](https://blog.arazygroup.com/regulatory-affairs-advance/author/arazy-group) Apr 18, 2024, 1:36:45 PM Brazil's Draft Resolution 1200, dated September 1st, 2023, outlining a streamlined process for evalu... 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