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AI agent for regulatory affairs specialists

Regulatory Intelligence Watch Agent

Every relevant regulatory change logged, assessed against products and assigned

ComplianceMonitoringRisk managementLegal
See how it worksGet access
Regulatory Intelligence Watch Agent: what goes in, what the agent does and what you get

What it does

Regulators publish guidance, rules and standards updates every week across many markets, and missing one can mean a product falls out of compliance. This agent scans agency websites, official journals and standards bodies daily for the team's product areas. It reads each item's scope and effective dates and matches the scope to the product register by market, product class and technology. If applicability is unclear from the data, it sends the question to a specialist and waits for an answer. For items that apply, it drafts an impact note listing affected products, documents and deadlines. Effective dates under 6 months are marked urgent. The specialist confirms impact and assigns actions. Edge case: draft guidance open for comment is logged with its comment deadline so the team can decide whether to respond.

How it works

Follow the arrows from top to bottom. The orange dashed arrow is the loop: when a check fails, the agent goes back and tries again.

Start and resultWhat it doesA check on its own workWaits for your OKGoes back and retries
Yes, continueApprovedNo 1 STARTS WHEN Daily scan 2 USES A TOOL Collect new items from agency sites and journals 3 DOES Read scope and effective dates 4 USES A TOOL Match scope to the product register 5 CHECKS THE RESULT Is the applicability clear from scope and registerdata? If not: send to a specialist with the question and waitfor an answer. Back to step 4. 6 DOES Draft impact notes listing affected products,documents and deadlines 7 YOU APPROVE Specialist confirms impact and assigns actions 8 RESULT Regulatory change log updated
Read the steps as a list
  1. Daily scan
  2. Collect new items from agency sites and journals
  3. Read scope and effective dates
  4. Match scope to the product register
  5. Is the applicability clear from scope and register data?If not: send to a specialist with the question and wait for an answer. Back to step 4.
  6. Draft impact notes listing affected products, documents and deadlines
  7. Specialist confirms impact and assigns actionsThe agent waits here for your OK.
  8. Regulatory change log updated

How it decides

An item applies when its scope matches a product's market, class or technology in the register. Unclear scope goes to a specialist.

  • Scope must match market and product class or technology
  • Comment deadlines are tracked for draft guidance
  • Effective dates under 6 months are marked urgent

Make it yours

Every agent is a starting point. You choose these settings for your own situation.

  • Agencies and markets to watch
  • Product register fields used for matching
  • Urgency window (default 6 months)
  • Digest frequency

What keeps you in control

It always asks you first

  • Specialist confirms applicability and assigns work

Hard limits

  • Uses official sources only
  • Never files comments with agencies

It stops when

  • Done: daily items processed
  • Stop: source unavailable; noted in the log

Set it up

We guide you through the set-up, step by step

Members get the full set-up guide for this agent. No technical skills needed: you copy, paste and upload.

10 minto set it up in your AI
5 AIsChatGPT, Claude, Copilot, Gemini, Grok
  • One set of instructions to paste into your AI, with the clicks for ChatGPT, Claude, Microsoft 365 Copilot, Gemini and Grok
  • The agent then walks you through connecting your own data, one source at a time
  • A downloadable copy with the flow chart, the rules and the full guide
Get access to this agent

An example run

What happensOn Mar 20, the EU published an amendment to MDR transition timelines, and the agent matched it to 14 products in the register. A separate FDA draft guidance on cybersecurity covered 'connected devices,' and 2 products had unclear connectivity data, so the applicability check failed. The agent sent both to specialist Lena Ortiz, who confirmed one applied. She approved the impact notes and assigned the actions.

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