The PenTest Index

MDS2: find the right form and check what it leaves out

By The PenTest Index · Sources checked October 10, 2026

MDS2 is the Manufacturer Disclosure Statement for Medical Device Security: a standard form a device maker fills out to describe the security features of one product. The current edition is ANSI/NEMA HN 1-2019, and NEMA offers the blank worksheet as a free download. A completed one is the maker's own statement about the product and software versions it covers, not a test result.

Below: where to get the form, how to tell if you have the right one, and a worksheet for turning its answers into questions for the maker.

Looking for the MDS2 gene instead? See NCBI Gene.

Where do you get the MDS2 form?

It depends which one you mean. The blank form comes from NEMA, the group that publishes the standard. The filled-in form comes from the company that makes your device.

Table columns: You need; Go here; Good to know.
You needGo hereGood to know
The blank form to fill outNEMA's MDS2 worksheet (Excel)The link returned an Excel file with no login or payment when we checked on October 10, 2026.
The full standard with instructionsANSI/NEMA HN 1-2019 at the ANSI storeA separate paid document. ANSI listed the PDF at $118 (US dollars) on October 10, 2026. You don't need it to read a completed form.
A completed form for your deviceThe maker. Some post them: Hologic keeps a public list by product and version. Others send them on request: AGFA HealthCare asks customers to email.These two are examples, not a full directory. If you can't find yours, use the request below.

We link to NEMA's form. We don't host it or copy its questions, because it isn't ours.

Which MDS2 covers your device?

The one written for your exact product and software version. A statement can cover a version range; yours must be included.

This matters more than it sounds. Hologic's public list, as we read it on October 10, 2026, has statements dated from October 2012 to June 2025. One product line, the SecurView review workstation, has four separate entries: versions 8 to 10 (March 2019), version 11.0 (December 2020), version 11.1 (February 2022) and version 12 (May 2025). Pick the wrong row and you are reading about software you aren't buying.

The edition of the form matters too. The same list includes a statement dated January 2022 whose file name says it uses the 2013 form, not the 2019 one. So a recent date doesn't promise the current form.

Before you read a single answer, check four things at the top of the statement:

  1. Product and model. Does it name what you're buying or running?
  2. Software version. Does it match your quote or your installed system?
  3. Document ID, revision and date. Can you tell which statement this is, and is it newer than the last software release?
  4. Form edition. Is it on the 2019 form?

If any of these is off or missing, stop and ask for the right statement first. It saves you from reviewing the wrong document.

How do you read Yes, No, N/A and the notes?

Read the question, the answer and the note together. A Yes is the answer to one specific question. It is not a gold star.

The two completed statements we read offer four kinds of answer: Yes, No, N/A, or See Notes.

Table columns: Answer; What it means; What to check next.
AnswerWhat it meansWhat to check next
YesThe maker says yes to that exact questionWhether the question describes a protection or a weakness, and under what setup
NoThe maker says no to that exact questionWhether it matters for how you'll use the device
N/AThe maker says the question doesn't applyWhether that makes sense for a device with these connections
See NotesThe real answer is in the noteThe note itself, word for word
Blank or unclearNothing has been statedAsk. Don't count it as a Yes or a No

Here is why you can't just count the Yes answers. One question on the form asks, in short, whether unapproved software or hardware can be installed without tools. A Yes there describes an opening, not a safeguard. In the two statements we read, bioMérieux's BIOFIRE SPOTFIRE statement answers Yes, and Hologic's SecurView 12 statement answers See Notes, with a note saying hardware would need tools and software would need an operating-system login. Neither answer is a verdict on the device. Each is a prompt to ask what stops it in your setup.

Notes can also move the answer somewhere you didn't expect. The SPOTFIRE statement (document BFR0001-8102-03, June 17, 2024) says in Note 18 that when its optional remote access features are installed, the remote access audit logs are available through that feature's administrator account and are not stored on the system. If your policy says "we must be able to pull remote access logs," the next question is who holds that account.

Both examples are the makers' own published statements. We read them. We did not test either device.

How do you check a completed MDS2?

Line it up against what you actually need, one condition at a time, and give every open point a question and an owner. That turns a long form into a short list.

This is our own review worksheet. It follows the same method we use across the site: take a real requirement, check it against the exact document, and record what the evidence does and doesn't back. Fill in your own conditions. The section codes are the labels used on the 2019 form.

Part 1. Is this the right document?

Table columns: Check; Your answer.
CheckYour answer
Product and model named on the statement
Software version on the statement / version you're buying or running
Document ID, revision and date
Form edition (2019?)
Options you plan to turn on (remote support, cloud, interfaces) and whether the statement covers them

Part 2. Does it meet your conditions?

MDS2 review worksheet topics, conditions, form sections, findings and questions.
TopicYour condition (must-have or nice-to-have, and who asked for it)Where to look on the formFindingQuestion for the maker
Data and connectionsCONN, TXCF, MPII and their notesWhich data path is protected, and how?
Logins and remote serviceAUTH, PAUT, RMOTWho can reach the device remotely, and how do we switch that off or watch it?
LogsAUDTWhere are the logs kept, and how do we get them?
Updates and supportCSUP, RDMPWho installs security patches, how fast, and until what date?
Software listSBOMCan you send the SBOM for this version?
Test evidenceNot on the formIs there a security test report for this version, and what did it cover?

Data and connections

Your condition (must-have or nice-to-have, and who asked for it)
Where to look on the form
CONN, TXCF, MPII and their notes
Finding
Question for the maker
Which data path is protected, and how?

Logins and remote service

Your condition (must-have or nice-to-have, and who asked for it)
Where to look on the form
AUTH, PAUT, RMOT
Finding
Question for the maker
Who can reach the device remotely, and how do we switch that off or watch it?

Logs

Your condition (must-have or nice-to-have, and who asked for it)
Where to look on the form
AUDT
Finding
Question for the maker
Where are the logs kept, and how do we get them?

Updates and support

Your condition (must-have or nice-to-have, and who asked for it)
Where to look on the form
CSUP, RDMP
Finding
Question for the maker
Who installs security patches, how fast, and until what date?

Software list

Your condition (must-have or nice-to-have, and who asked for it)
Where to look on the form
SBOM
Finding
Question for the maker
Can you send the SBOM for this version?

Test evidence

Your condition (must-have or nice-to-have, and who asked for it)
Where to look on the form
Not on the form
Finding
Question for the maker
Is there a security test report for this version, and what did it cover?

For each finding, use one of five labels:

  • Supported: the statement backs your condition.
  • Mismatch: the statement rules it out.
  • Unresolved: the statement doesn't say, or points to a document you don't have.
  • Conflicting: the statement disagrees with the manual or another document.
  • Not applicable: the condition doesn't arise for this device.

Supported means the maker said so in writing. It does not mean anyone tested it. And don't average the findings into a score. One Mismatch on a must-have is a Mismatch, however many rows look fine.

A worked review using a public statement

The short version: for the made-up hospital below, the statement we read does not support one of its must-haves, and leaves another open. So the hospital has two questions to send before it goes further.

Say a hospital is reviewing SecurView 12.0. Its own purchasing policy (made up for this example) has two must-haves. The application itself must encrypt patient studies in transit using TLS, the standard way of protecting a network connection. And the hospital must have a written list of the network ports and protocols the device uses. These are this hospital's rules. They are not MDS2 or FDA rules.

We checked them against Hologic's SecurView statement, document RD-04687 Revision 002, dated May 1, 2025, read on October 10, 2026.

Table columns: Hospital's must-have; What the statement says; Finding; Question to send.
Hospital's must-haveWhat the statement saysFindingQuestion to send
The statement covers SecurView 12.0Device model reads "SecurView 12.0 and later" (DOC-3)Supported for the product named"We're installing version [x] with [options]. Does this statement cover that setup?"
The application encrypts study transfer with TLSThe form answers Yes to "supports TLS" (CONN-7), but Note 26 says patient study transmission to external devices uses DICOM, the medical imaging transfer standard, "without TLS," and that the customer may set up TLS at the network layerMismatch with this hospital's policy"Is there a supported setup where the application encrypts study transfer? If not, please describe the network-layer option you support."
A written ports and protocols list in handThe form answers Yes, "Available upon request" (CONN-2)Unresolved until the list arrives"Please send the ports and protocols list for version 12."

Look at the middle row again. Someone skimming for Yes answers would have marked TLS as fine. The note is what changes it.

What the hospital does next follows from the findings. It asks the two questions. If the maker documents a setup that meets the TLS rule, that row becomes Supported. If not, the hospital either changes its own rule to accept network-layer protection, with whoever owns that rule signing off, or it doesn't approve this setup. This is a narrow finding against one made-up policy. It says nothing about whether the device is safe.

What should you ask the manufacturer for?

Ask for the statement that covers your exact setup, plus the documents behind any answer you're relying on. Here is a request you can adapt.

Subject: MDS2 and security documents for [product, software version]

Please send the current completed MDS2 for [product and model], software version [x], with these options enabled: [list]. Please tell us its document ID, revision and date, and confirm it covers this setup. If it isn't on the 2019 form (ANSI/NEMA HN 1-2019), please say so.

We're reviewing this for [purchase / network onboarding / other]. Our must-have conditions are: [list each one and who requires it].

Please also send the documents your answers point to, including the ports and protocols list, the patch and support policy, the SBOM for this version, and any security test report you can share.

For any answer that depends on how the device is set up, please explain the supported setup, who is responsible for it, and any added cost.

Please name a contact for follow-up questions and reply by [date].

Sending this asks for documents. It doesn't give anyone permission to test the device.

What can't an MDS2 tell you?

It can't tell you whether any of it works. The maker fills in the form. The form itself is not a test result.

Three documents often get mixed up. They answer three different questions.

Table columns: Document; The question it answers; What to ask for.
DocumentThe question it answersWhat to ask for
MDS2What security features does the maker say this version has?The completed statement for your version, plus the documents it points to
SBOM (software bill of materials)What software is inside?The actual list for your version. A Yes to "is an SBOM available" is not the list.
Penetration test reportWhat could testers actually do to it, and what did they find?The report itself, with its scope, dates, methods and results

A penetration test is people trying to break in. A filled-in form is a company describing its own product. Both are useful. Only one is evidence of how the device held up.

When is testing the next step?

Most readers don't need to buy anything. Get the right statement, run the worksheet, send the questions. Testing comes up in three cases:

  • Someone asks for it. Your customer, your security team or a regulator wants test evidence. First check whether a report already exists for this version and covers what they asked for.
  • A must-have stays open. The maker has answered and you still can't tell whether a condition is met.
  • You need to know how it behaves on your network. A maker's statement describes the product, not your setup.

If you're a hospital, two safety rules come before anything else. Never test a device connected to a patient. And get written approval that names the device and the activities, because a general network test agreement doesn't automatically cover it.

When you do need testing, our medical device guide compares what five providers publish, including prices where they exist, and gives you a brief to send so every quote answers the same question: compare medical device penetration testing offers.

Not sure yet what kind of test you'd even ask for, or who needs the report? Find My PenTest Match is our free scope checklist. You copy or print it, and it asks for no email. It doesn't list device testing firms, so use it to get your questions straight, then use the device guide to find who to ask.

Find My PenTest Match

Is an MDS2 required by the FDA?

Not by name, in anything we read. FDA recognizes the standard and mentions the form as one way to share security information with customers. Whether you need one usually comes down to what your customer's contract says.

Here is what the sources say, set beside what you may hear.

Table columns: What you may hear; What the source says; What to do with it.
What you may hearWhat the source saysWhat to do with it
"FDA requires an MDS2."FDA's current premarket cybersecurity guidance, issued February 3, 2026, names it once, in the labeling section (VI.A). It says a revision-controlled MDS2 and customer security documentation "may address a number of the above recommendations." Every page of that guidance is marked as nonbinding.Treat it as a recognized way to communicate, not a filing FDA demands.
"FDA ignores it."FDA lists ANSI NEMA HN 1-2019 as a recognized consensus standard (recognition number 13-123, entered December 19, 2022, complete standard).It's recognized.
"A good MDS2 covers your FDA cybersecurity duties."The same FDA record says conformance "may not satisfy all the cybersecurity requirements outlined in Section 524B." The guidance describes that law as asking covered device makers for a vulnerability plan, security processes and an SBOM. It doesn't list an MDS2.An MDS2 is not enough on its own. Your regulatory lead decides what your submission needs.

Sources: FDA recognition record and FDA guidance, both read October 10, 2026. For more on the guidance, see our FDA cybersecurity guidance tracker.

Hospitals are a different matter. A hospital can make an MDS2 a condition of buying, and many treat it as part of their security review. That is the buyer's rule, not a law. If a customer has asked you for one, their contract or questionnaire is the thing to read.

Which edition is current, and is a new one coming?

The 2019 edition, ANSI/NEMA HN 1-2019, is current. ANSI's store marks it "Most recent" and shows it replacing the 2013 edition. The form goes back further than that: the earliest edition dates to 2004, with revisions in 2008 and 2013.

A new edition is on NEMA's schedule. NEMA's 2026 Standards Plan lists a technical revision of HN 1 with an expected publication date of December 31, 2026, and no published status as of October 10, 2026. An expected date is a plan. Until NEMA publishes it, ask for the 2019 form.

When a new edition does arrive, expect a mix for a while. Makers took time to move from 2013 to 2019, as the January 2022 example above shows. The four checks at the top of the statement will still tell you what you're holding.

Device makers: how do you fill one out so it holds up?

Have the people who know the product fill it in, one statement per product and software version, and keep it under revision control. "Revision-controlled" is FDA's own wording.

A few things make the difference between a statement a hospital trusts and one it sends back:

  • Name the version. A hospital's first check is whether your statement matches what they're buying.
  • Write the notes. If the honest answer is "yes, when set up this way," say which way and who does it. A bare Yes that turns out to have conditions costs you more trust than the condition would have.
  • Match your other documents. Your answers should agree with the manual, the SBOM and what your own security testing found. Reviewers compare them.
  • Have the attachments ready. If you answer "available on request," expect the request.
  • Update on real changes. A new software release, a change to remote access or a new end-of-support date are all reasons to issue a new revision. That is our suggestion, not a rule from the standard.

If a customer sends their own security questionnaire as well, that's a separate request. Reuse the evidence behind your MDS2, but don't assume the form answers everything they ask.

And if you find you're writing answers with no test evidence behind them, that is the gap to close. Our medical device penetration testing guide covers what a test should include and what FDA's guidance says a report should show.

Other questions about the form

Can I accept an MDS2 on an older form?

Ask for the 2019 form first. If the maker only has an older one, it can still tell you something, but check the date and version carefully and expect to ask more follow-up questions. Whoever owns your security review decides whether that's good enough.

Does an MDS2 expire?

We found no fixed expiry in the sources we read. Judge it by whether it still matches the software you run. If the software has changed since the statement's date, ask what changed in security.

What if the maker won't send one, or it isn't public?

Not being posted online doesn't mean a control is missing. Many makers share statements only with customers. Ask through your sales or support contact, mark the open points Unresolved, and let your security lead decide whether you can proceed without it.

Who fills out the MDS2?

The device maker. A hospital shouldn't fill in a maker's answers for it, and a blank form sent to a hospital isn't much use until the maker completes it.

How we checked

We read FDA's recognition record and current guidance, ANSI's listing, NEMA's standards plan, two completed manufacturer statements and two manufacturer request pages on October 10, 2026. We did not buy the full standard, test any device or contact any maker, and the hospital in the worked example is made up. We don't perform, authorize or certify testing. More on how we check sources and how we make money.

Sources, all checked October 10, 2026