Sources
Rules come from three documents: MHRA, Medical device stand-alone software including apps (including IVDMDs) , v1.10g (UK); MDCG 2021-24 Rev.1, Guidance on classification of medical devices , April 2026 (EU, MDR); FDA, Clinical Decision Support Software , 29 January 2026 (US). For IVD software the tool also uses Regulation (EU) 2017/746 (IVDR) Annex VIII; MDCG 2019-11 rev.1 (June 2025); MDCG 2020-16 rev.5 (September 2026); UK Medical Devices Regulations 2002 Part IV and Directive 98/79/EC Annex II (UK IVD lists). Page references in the questions and results point into those documents. For the US the tool also relies on FDA, General Wellness: Policy for Low Risk Devices (6 January 2026); Policy for Device Software Functions and Mobile Medical Applications (28 September 2022); Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices (September 2022); Multiple Function Device Products (July 2020); In Vitro Companion Diagnostic Devices (August 2014); the final guidance on Predetermined Change Control Plans for AI-Enabled Device Software Functions ; Cybersecurity in Medical Devices (February 2026) and FD&C Act section 524B; FD&C Act sections 510(k), 513, 515, 515C and 520(o); 21 CFR parts 801, 803, 806, 807, 809, 812, 814, 820, 830, 860 and 862 to 866; and 42 U.S.C. 263a (CLIA). Anything marked "not supplied" comes from outside them and needs checking.
For physical devices the tool uses Regulation (EU) 2017/745 (MDR) Annex VIII and Annex XVI; MDCG 2021-24 Rev.1 (April 2026); UK Medical Devices Regulations 2002 reg 7 and 13 with Directive 93/42/EEC Annex IX, and Directives 2003/12/EC and 2005/50/EC as applied in Great Britain; and, for the US, FD&C Act sections 513(a), 503(g) and 524B and 21 CFR parts 3, 4, 801, 820, 821, 860, 862 to 892 and 1000 to 1040 with the FDA guidance named in the results. Northern Ireland follows the MDR.
For the US the tool also uses the FD&C Act, 21 CFR and the FDA guidance listed in the results to give a likely class and route. Record the product code and regulation you confirm in FDA's database.
Not affiliated with or endorsed by the MHRA, the European Commission or the FDA. Contains public sector information licensed under the Open Government Licence v3.0; EU material reused under Decision 2011/833/EU; FDA guidance is a US government work. Terms of Use · Privacy notice
Terms of Use
Last updated: 30 October 2026
Who we are
This tool is provided by MD QMS Ltd of 9 Upland Road, St Helens, United Kingdom, WA10 3SQ ("we", "us"). You can contact us at ai@mdqms.co.uk . By using the tool you accept these Terms. If you do not accept them, do not use the tool.
Business use only
The tool is for businesses, such as medical device manufacturers and their advisers, assessing their own software or devices. You confirm that you are using it in the course of a business and not as a consumer. If you use it on behalf of a company, you accept these Terms for that company.
Beta version
The tool is a beta version that is still being tested. Its questions, rules and results may change without notice and may contain errors or omissions.
What the tool does
The tool asks questions about standalone software and about physical devices (including devices with built-in software) and gives a provisional view of how it might be classified under UK (MHRA), EU (Medical Device Regulation) and US (FDA) rules. It works from published guidance and from your answers. It does not cover every type of product or pathway, and its limits are listed in the "What this tool does not do" notice on the page.
No advice and no reliance
The output is general information. It is not regulatory, legal or other professional advice, and it is not a decision by the MHRA, the European Commission, any notified body or UK approved body, or the FDA. We do not assume any responsibility to you for the output, and we do not owe you a duty of care in respect of it. You remain responsible for the classification of your product and for meeting the regulatory requirements that apply to it. Before you make any regulatory, commercial or investment decision, you should confirm the classification with the relevant regulator, notified body or UK approved body, or with a qualified adviser.
Provided "as is"
The tool is free and provided "as is" and "as available". Regulatory guidance changes, and the tool may contain errors or be out of date. To the extent the law allows, we give no warranty, condition or other term, express or implied, that the tool or its output is accurate, complete, current, or fit for any purpose. We may change, suspend or withdraw the tool at any time without notice.
Not a medical device
The tool is not a medical device. It does not diagnose, treat or monitor any person and must not be used for clinical purposes or for decisions about the care of any patient.
Limits on our liability
Nothing in these Terms limits or excludes our liability for death or personal injury caused by our negligence, for fraud or fraudulent misrepresentation, or for anything else that cannot be limited or excluded under the law of England and Wales.
Subject to that, we will not be liable to you, whether in contract, tort (including negligence), breach of statutory duty or otherwise, for:
any indirect or consequential loss;
loss of profit, revenue, business, contracts, investment, goodwill or anticipated savings;
any cost, delay or refusal connected with a regulatory submission, conformity assessment, clearance, approval, registration or enforcement action, including the cost of reclassification, redesign, further testing or additional evidence; or
loss or corruption of data, including answers saved in your browser.
Subject to the same exceptions, our total liability to you arising from or in connection with the tool or these Terms is limited to £100.
You agree that these limits are reasonable because the tool is free, the output is provisional, you are a business able to take your own advice, and you are told to confirm every result before relying on it.
Your responsibilities
Do not enter personal data about any individual, including patient data, into the tool. Do not use the tool in a way that is unlawful or that interferes with its operation.
No affiliation
We are not affiliated with, endorsed by or acting for the MHRA, the European Commission or the US Food and Drug Administration. References to their guidance do not mean that they approve the tool or its output. UKCA, CE and FDA marks and logos are not used and are not implied.
Source material
The tool refers to and summarises public guidance:
MHRA material contains public sector information licensed under the Open Government Licence v3.0.
European Commission material is reused under Commission Decision 2011/833/EU on the reuse of Commission documents. The Commission is not responsible for our use of it.
FDA guidance is a work of the United States Government and is not subject to copyright in the United States.
The tool's own text, logic and design belong to us or our licensors.
Changes to these Terms
We may update these Terms. The date at the top shows when they last changed. The version in force when you use the tool applies to that use.
General
If any part of these Terms is found unenforceable, the rest remains in effect. These Terms are the whole agreement between you and us about the tool. No one other than you and us has any right to enforce them.
Law and jurisdiction
These Terms, and any dispute or claim (including non-contractual disputes or claims) arising from or connected with them or the tool, are governed by the law of England and Wales. The courts of England and Wales have exclusive jurisdiction.
Privacy notice
Last updated: 30 October 2026
Who we are
This tool is run by MD QMS Ltd of 9 Upland Road, St Helens, United Kingdom, WA10 3SQ. For any privacy question, contact ai@mdqms.co.uk .
What we collect
We do not ask for your name, email or any account details, and we do not collect the answers or notes you enter.
When your browser loads the page, our hosting provider's servers receive your IP address and basic request details (such as browser type) so they can deliver it. This is how every website is served. We do not run our own logs or analytics, and we do not use this information. Our hosting provider is Vercel Inc., a company based in the United States, which serves the page from servers in several countries and may keep standard request logs and process this information for security and to run its service, under its own terms.
After the page has loaded, it makes no further network requests. It uses no cookies, analytics, advertising, tracking, third-party scripts or third-party fonts.
Your answers stay in your browser
Your answers and notes are saved in your browser's local storage so you do not lose your work. They are not sent to us. This storage is strictly necessary for the feature you are using, so it does not need consent under the Privacy and Electronic Communications Regulations. Anyone with access to the same browser profile can see them.
To delete them, use the "Clear saved data on this device" button, or clear site data in your browser settings.
Files you save
"Save case" and report downloads are created in your browser and saved to your device. We never receive a copy. What happens to them afterwards is up to you.
Do not enter personal data
The tool does not need personal data. Do not enter information about any patient or other identifiable person, in your answers or your notes.
Your rights
Because we hold no personal data from the tool, we will usually have nothing to provide in response to a request. You still have rights under UK data protection law, including to ask what we hold and to object. Contact ai@mdqms.co.uk . You can also complain to the Information Commissioner's Office at ico.org.uk or on 0303 123 1113.
Changes
We will update this notice if how the tool works changes. The date above shows the latest version.