When a regulation changes, see exactly which paragraphs moved — and which of your devices they affect. Built on the live MD Atlas EUDAMED database: 764k+ devices already indexed.
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§4.2 — Review of post-market surveillance dataThe manufacturer should shall review post-market surveillance data at appropriate intervals at least annually, and shall document the results of trend analysis in the technical documentation.
Follow one change through the pipeline — from publication to audit-ready proof.
Regulatory change starts somewhere official — a directorate, an agency, a standards body. Regulatory Intelligence is built to monitor 200+ sources. The EU corpus is live today; the rest ships in the order early-access members vote.
Green = live in MD Atlas today. Blue = on the roadmap — early-access members vote on the order.
The same regulatory event, delivered two ways. One is a reading assignment. The other is a work item with a device name and a deadline on it.
📎 Weekly digest: 14 regulatory updates in the EU
Now it's your job: read it, figure out whether it applies, check each device, find the documents, set your own deadline. The tool stopped at "something changed".
Post-market surveillance (PMS) update — affects 3 of your 12 devices
One owner notified, the exact documents named — down to the standard operating procedure (SOP) — with deadlines attached and the official source linked. The database did the "does this apply to us?" step for you.
Illustrative volumes: 1,284 publications scanned last month → 3 touched this portfolio → 1 owner notified. Every exclusion is logged with a reason. Fictional portfolio, invented generic reference.
A revised guidance is a 40-page PDF; the change is four sentences. Paragraph-level redlines show what was added, what was removed, and which edits change what reviewers expect of you. Behind every diff sits its evidence record.
§4.2 — Review of post-market surveillance dataThe manufacturer should shall review post-market surveillance data at appropriate intervals at least annually, and shall document the results of trend analysis in the technical documentation.
Note: the clause above is an invented, generic example written for this page — not the text of any real MDCG document.
Your devices are already in MD Atlas through your public EUDAMED registrations — so a change is matched against what you actually make, not against a keyword.
FR-MF-000012345 (your company's registry number) · 12 devices · classes I–IIbMDCG 20XX-7 rev 3 — PMS update3 of 12 devices affected · fictional portfolio & invented reference, for illustration| Device | Class | Impact | What needs updating | Deadline |
|---|---|---|---|---|
| Infusion pump IP-200 | IIb | Affected | Technical File §7 · SOP-017 | 20XX-08-15 |
| Patient monitor PM-4 | IIa | Affected | PMS plan · data-review procedure | 20XX-08-15 |
| Wound dressing WD-A | IIb | Affected | Clinical evaluation · PMS plan | 20XX-09-10 |
| Surgical scalpel SC-9 | I | No impact | class I — different reporting rules apply | — |
| + 8 more cleared — each with a logged reason, not silence. | ||||
the matrix scrolls sideways — swipe to see all columns
No import step, no device spreadsheet to maintain: connecting your portfolio is resolving your company's registry number. The matching, the matrix and the deadlines are the layer we're building on top.
A change you've read is still a liability until someone owns the response. Each action carries the clause it derives from and one owner — and everything lands on one timeline.
the timeline scrolls sideways — swipe to see all milestones
⏱ 180 days remaining · 1 of 4 actions closedWhen the auditor asks "how did you learn of this change, and when?" the answer should be a record — source → date → owner — not a recollection.
Every document links back to the issuing authority — EUR-Lex, MDCG, EUDAMED — with official-source attribution already on every record in the corpus.
Prior revisions stay retrievable side-by-side — so when redlines ship, diffs will be computed between held versions, never against a page that no longer exists.
Each captured version will be fingerprinted, so you can prove what the text said on the day you assessed it — even if the source page changes later.
Who was notified, who assessed impact, what was decided and when — exportable as audit-ready evidence for your QMS.
"I don't need 1,200 publications. I need the ones that touch my devices — and proof of why the rest don't."
"Show me the exact paragraph that changed and what it asks of us — before the notified body asks."
"When did we learn of this change, who assessed it, and where's the record? I need the chain, not the story."
"My clients pay for answers anchored in the official text — with the version history to back them up."
Regulatory Intelligence is in active build on top of the live MD Atlas platform. Join the early-access list to vote on which sources ship first, preview the redline and impact features as they land, and lock the best rate at launch. No commitment, no card — just a front-row seat.
Everything else on this page carries a blue Coming chip and is what early access funds and shapes. A monitoring product that fudges its own status isn't one you should trust with yours.
Not yet, and we won't pretend otherwise. The platform is built to monitor 200+ sources; today the ingested corpus is EUR-Lex (MDR/IVDR) and MDCG guidance on top of the EUDAMED registry data. The early-access list directly drives which sources we ship next — FDA, ISO, IEC, MHRA, Health Canada, PMDA and the national authorities are the current front of the queue.
Because it's public register data we already hold. Your EUDAMED registrations — devices, Basic UDI-DIs, risk classes, certificates — are in the MD Atlas database today. Connecting your portfolio is resolving your SRN (your company's registry number), not uploading a spreadsheet. The starting point is already populated from the public register — you then trim or extend it, and devices not yet registered in EUDAMED can be added manually.
That's MD Atlas AI — a separate, later offering that drafts the impact memo, the SOP revision, the customer notification. It's grounded in the same evidence records, with the same citations. Regulatory Intelligence stands on its own; the assistant is where it goes next.
Pricing is announced at launch. What we can say now: early-access members lock the best founding rate, and joining the list costs nothing and commits you to nothing. If you want to talk specifics for your team, book a demo and we'll walk through it. No plan changes to existing MD Atlas subscriptions are implied by this page.
From publication to proof — with your portfolio, not a keyword list, deciding what you see. Get in before launch and help decide what ships first.
Built on the live MD Atlas EUDAMED database · official sources only.