Track regulatory changes

Name a regulatory body, a therapy area or product category, and a time window, and Anara searches for new guidance, consultations, enforcement actions, and policy announcements, then tells you what changed and what needs your attention. Use it as a regular monitoring pass.

Prompt

A medical device regulatory affairs manager needs 60 days of EU guidance on software as a medical device.

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- Any new or draft guidance from the EMA on AI and machine learning-based medical devices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.

What to add to your library

• Required: nothing to upload. Anara searches live public sources from the prompt.
• Optional: the regulatory bodies relevant to your markets (FDA, EMA, MHRA, TGA, PMDA, Health Canada).
• Optional: your prior monitoring brief, so Anara covers only what is new since then.

What you get

• A monitoring brief across the named agencies and topic.
• For each item: the document, the date, and the key change or proposal.
• A call on whether each item needs action, monitoring, or no immediate response.

Follow-ups

Read one guidance document in detail.

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.

Check your current template against new guidance.

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.

Tips

• Name the agency and product category together for a more focused search than either alone.
• Add a time window. For active areas like AI and digital health, 30 days beats 90.
• Items published in the last 24 to 72 hours may not appear yet. Verify critical timelines on the agency's publications page.
• Anara cannot reach password-protected submissions or guidance sent only to registered contacts.