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Name a regulatory body, a therapy area, or a product category and the time window you need to cover. Anara searches for recent guidance documents, public consultation outcomes, enforcement actions, and policy announcements, then returns a synthesis of what changed and what it means for your work. No files to upload.

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1. Describe the task

Regulatory guidance moves faster than most monitoring systems can track. A new FDA draft guidance on a Thursday afternoon, an EMA reflection paper open for consultation, a NICE appraisal published between quarterly reviews. The professionals who catch these earliest are monitoring more systematically, not reading more. Anara can run a regulatory monitoring pass for you. Name the agency, the therapy area or product category, and the time window. Anara searches agency websites, industry reporting, and medical news sources in parallel, reads the most relevant documents it finds, and returns a synthesis covering what was published, what it means for your area, and what requires your attention. Here a regulatory affairs manager at a medical device company needs a rapid summary of EMA and EU MDR-related guidance published in the last 60 days that affects software as a medical device (SaMD) classification and clinical evidence requirements. 
I need a regulatory monitoring brief for software as a medical device (SaMD) covering the last 60 days.

Please search for:
- Any new or draft guidance from the EMA on AI and machine learning-based medical devices
- Any updates to MDCG guidance on EU MDR classification or clinical evaluation for SaMD
- Any public consultation documents from the European Commission relevant to the AI Act's interaction with MDR
- Any enforcement actions or notable EUDAMED updates relevant to digital health devices

For each item found, tell me: what it is, when it was published, what it changes or proposes, and whether it requires immediate attention or monitoring only.

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2. Give Anara context

Required context
  • Nothing to upload. Anara searches live public sources from the prompt.
Optional context
  • The specific regulatory bodies you want covered. Naming FDA, EMA, MHRA, TGA, PMDA, or Health Canada focuses the search on the agencies relevant to your markets.
  • A prior monitoring brief from the last cycle. Anara identifies what is new since that date rather than re-covering known ground.
  • Your product category, device classification, or therapy area. Helps Anara weight results toward guidance with direct applicability to your situation.

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3. What Anara creates

A monitoring brief covering recent regulatory publications across the named agencies and topic. Each item identifies the document, the date, the key change or proposal, and whether it requires action, monitoring, or no immediate response. The brief is what you share with the regulatory team at the start of the week or take into a committee meeting that needs a current picture.

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4. Follow-up prompts

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Read a specific guidance document in detail

When the monitoring brief surfaces a document that needs deeper analysis. 
You identified a new MDCG guidance paper on clinical evaluation for AI-based devices. Read the full document at the URL you cited and summarize the specific changes to clinical evidence requirements for machine learning models that update their performance after deployment.

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Compare new guidance to your current approach

When a new document may affect something you have already submitted or are currently preparing. 
Based on the new MDCG guidance on AI device clinical evaluation, how does it differ from what we were using before? I have uploaded our current clinical evaluation report template. Flag any sections of our template that may need to be updated to comply with the new guidance.

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Set up a recurring monitoring brief format

When you want to use the same monitoring approach on a regular basis. 
Save this monitoring brief as a note called "SaMD Regulatory Monitor - April 2026." Next time I ask for the SaMD regulatory brief, start from this note and cover only what has been published since today's date.

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5. Tricks, tips, and troubleshooting

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How you word your prompt shapes what you get

Naming the agency and product category together produces a more focused search than naming either alone. Adding a time window (last 30 days, since January 1, 2026) prevents Anara from returning foundational guidance you already know about. For active regulatory areas like AI and digital health, a 30-day window is more useful than a 90-day window: there is enough new material without older items dominating the brief.

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Check the output against your own understanding

Anara searches publicly available sources. Publications within 24 to 72 hours may not yet appear in search results. For critical timelines, verify the brief against the agency’s publications page directly. Anara cannot access password-protected submissions, internal agency communications, or guidance distributed only to registered contacts. If an expected item is missing, check the agency website directly.

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What to do with the output next

Distribute the brief to your regulatory team with a note on which items require action and by when. For draft guidance open for consultation, confirm whether your organization plans to submit comments and by what deadline. For finalized guidance that changes existing requirements, assess which current submissions need updating before the implementation date. Archive briefs by date as a running record of what changed and when.