LEGAL
Last updated August 2026.
MDClassify is operated by V22 Media, VAT number 02905201204, registered office Via Verdi 20, 40026 Imola (BO), Italy. Contact: studio@v22media.com.
These terms govern your use of www.mdclassify.com. By using the service you accept them. If you are using it for an organisation, you confirm you are authorised to accept on its behalf.
MDClassify produces a preliminary, informational indication of the risk class of a device under Regulation (EU) 2017/745. It is not legal or regulatory advice, is not a conformity assessment, and is not a binding confirmation from a Notified Body or a Competent Authority. Under Article 10 of the Regulation, responsibility for correctly classifying a device and documenting the rationale lies with the manufacturer alone. Results depend entirely on the answers provided and on the intended purpose as declared by the user; an incorrect or incomplete intended purpose will produce an incorrect class.
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The result depends entirely on the answers you give and on the intended purpose you declare. An intended purpose that is incomplete, aspirational, or inconsistent with your marketing claims will produce a wrong class, and the tool has no way to detect that.
Under Article 10 of Regulation (EU) 2017/745, and the equivalent provisions in other jurisdictions, the manufacturer is responsible for classifying its device correctly and for documenting the rationale. Nothing here shifts that responsibility. You agree to have any classification confirmed by a qualified regulatory affairs professional before using it for a regulatory submission, a market access decision, or any commercial commitment.
The scope of the engine is published and versioned. All 22 rules of Annex VIII are evaluated against every classification. 13 are determined from the answers alone; 5 are determined but rest on a regulatory judgement you declare, which the report names so it can be checked; 2 cannot be settled by an engine at all and are reported as open; and 2 have a branch that is not yet implemented, listed by name. The rule-by-rule statement of what is determined, what rests on a judgement you declare, and which branches are not yet implemented is on the regulatory framework page, and the same statement is reproduced in every report. Where that page and a report differ, the report governs the result it accompanies, because it records the engine as it was on the day it ran.
We build the engine carefully and correct errors when we find them, but we do not warrant that results are accurate, complete, or current with the latest guidance. Regulations and their interpretation change; a result is a snapshot of the day it was produced.
Where you enrol in the beta programme, you undertake to send at least 5 pieces of substantive feedback on classifications you have run, signed with your name and professional role. In exchange we undertake to provide free access for 36 months from the date your fifth piece of feedback is received, beginning when the beta ends and paid plans start, up to 50 classifications a month.
Feedback you send under the programme is identified to us and is not published, quoted, or attributed to you publicly. If we ever want to publish something you wrote, we will ask you at the time, for that item, and you may refuse without affecting your entitlement.
The entitlement is personal to you and to the address you enrolled with. It does not transfer to an employer, a client or a successor practice, and it covers the classification and report as they exist when the beta ends rather than markets or paid features added afterwards. Enrolment is automatic; we assess no one, so being enrolled is not a qualification and should not be presented as one. The version of the programme in force is beta-2026-08-05, and a later version does not alter what was agreed with anyone who enrolled under an earlier one. Full conditions are on the beta programme page.
The service is provided on an “as available” basis. We may change, suspend or withdraw any part of it, including changing the classification logic as regulations evolve. We do not guarantee uninterrupted availability, and we may delete stored submissions in line with the retention period set out in the privacy policy. Keep your own copy of any report that matters to you.
You agree not to:
We may suspend access where these terms are breached.
Submit only information you are authorised to use for the purpose of obtaining a classification report. Where you use the service on behalf of a client, an employer or another organisation, you confirm that you are authorised to submit that device information and to receive and use the resulting report on their behalf.
The service is built to process information about devices, not about people. Do not enter health data, special-category personal data under Article 9 GDPR, patient information, or any other personal data that is not strictly necessary for the service you are requesting.
The free-text fields exist to describe an intended purpose. Nothing in the engine reads them to classify, so there is no benefit to putting anything else there — and a considerable cost if you do.
You remain responsible for the lawfulness, accuracy and completeness of what you submit.
You keep all rights in the name, logo, professional title and review notes you upload. You confirm that you own them or hold the permissions needed to use them and to authorise their reproduction in reports generated here, and you grant us a non-exclusive, limited licence to host and reproduce them for the sole purpose of providing the service.
Do not upload a mark, name, qualification or statement that is misleading, infringes somebody else's rights, or suggests that MDClassify, a Competent Authority, a Notified Body or any other third party has certified or endorsed the device or the report. We may remove or disable material we reasonably believe to be unlawful, misleading or infringing.
Where a professional adds a review note, a name, a qualification or a mark to a report, that material is theirs. It does not become a statement, an endorsement or a professional opinion of ours, and the document is not a joint report or a co-signed classification. What it is, and what it says it is, is an automated classification report carrying an independent professional review.
We are responsible for the technical operation of the platform, for implementing in software the rules we say we implement, for the integrity of the generated document, and for keeping the automated output visibly separate from the professional's material.
The reviewing professional is responsible for their assessment of the particular device, for the accuracy and scope of what they write, for the qualifications they state, for the use of their own mark, and for their relationship with their own client.
The manufacturer remains responsible for the intended purpose, the qualification of the product, the final classification and its documented rationale, under Article 10 of the Regulation. Nothing in a reviewed report moves that responsibility to us or to the reviewer.
Except for material you submit, public legislation, and third-party components identified as such, the intellectual property rights in this service are owned by or licensed to us. Where protected by applicable law, that covers the software code, the interface, the original text, the database and questionnaire structure, the selection and organisation of content, the report layout, and the implementation of the classification engine.
It does not cover the rules themselves. Anyone is free to apply Annex VIII, or any other classification framework, to their own device; what is protected is our expression of it, not the law.
The device information you enter remains yours. You receive a non-exclusive right to use, reproduce and share the report you generate for your own business, regulatory and advisory purposes — including with your advisors, a Notified Body or an authority.
You may edit the editable version of the report: a professional often needs to. What you must not do is misrepresent where it came from. If you make material changes, those changes must be distinguishable, and the altered document must not be presented as an unmodified MDClassify report.
You may not extract, systematically reproduce, reverse engineer or republish the service, the questionnaire, the database, the report templates or the classification logic in order to build or run a competing service, except where that restriction is prohibited by mandatory law.
The text of Regulation (EU) 2017/745 and other legislation referred to is public and not claimed by us.
The service is provided free of charge during the beta. We do not warrant that a result is a definitive classification, that it will be shared by a Notified Body or an authority, or that it is complete for your device: the output depends entirely on the answers you give, and the service does not verify them.
To the fullest extent permitted by law, we exclude liability for indirect and consequential loss — regulatory delay, rejected submissions, the cost of reclassification, lost profit, lost opportunity and reputational harm.
We do not exclude our liability for direct loss caused by a failure of the service itself, such as a rule implemented incorrectly or an engine that does not do what these terms say it does. That is what we undertake to provide, and a promise that excluded every consequence of breaking it would not be a promise.
Nothing in these terms limits liability that cannot lawfully be limited: in particular death or personal injury caused by negligence, fraud or fraudulent misrepresentation, gross negligence or wilful misconduct, and any rights you have as a consumer under mandatory law. Every exclusion above applies only to the extent the law permits it; if a court finds one excessive, it is reduced to what is permitted rather than striking the whole clause.
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The service is in beta and everything in it is free: classifications, reports and the cross-market comparison, without limit. No payment details are collected, and nothing can be purchased today.
The pricing intended after the beta is published on the home page — ten reports each month free, then a charge per report — but it is an announcement of intent, not an offer, and it binds nobody until terms of sale exist. When they do, the price, delivery and any right of withdrawal will be presented before payment and will take precedence over this section for that purchase.
One commitment is made now and is intended to be binding: classifications produced during the beta remain available in the account they were created under, and the reports produced from them can be regenerated at no charge for as long as the service exists.
We may update these terms — for example when the service changes, or when the law does. The date at the top shows the last revision, and the change takes effect only for use after it is published.
A change that materially reduces your rights will be shown prominently on the site before it applies, not buried in a revision date. You are always free to stop using the service, and doing so is your remedy if you do not accept a change. Nothing here allows us to alter retrospectively the terms that applied to a report already produced.
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These terms, and any non-contractual obligations arising from them, are governed by Italian law.
Where you act in the course of a trade, business or profession, the courts of Bologna, Italy, have exclusive jurisdiction, subject to any mandatory jurisdiction that cannot lawfully be excluded.
Where you are a consumer, this choice of law does not deprive you of the protection of mandatory provisions of the law of the country in which you are habitually resident, and you may bring proceedings before the courts competent under the applicable consumer-protection and jurisdiction rules.
Write to service@mdclassify.com first. Most disagreements are a misunderstanding about what the tool claims to do, and those are quicker to resolve directly.
Consumers resident in the EU may also approach a national alternative dispute resolution body, or the European Consumer Centre in their country.
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