Terms and Conditions

1. About these Terms

These Terms and Conditions (Terms) form a binding agreement between you and Lee Freeman, a sole trader trading as MLR PreCheck, of 54 Chestnut Lane, Ashford, Kent, United Kingdom (MLR PreCheck, we, us or our). They govern your access to and use of the MLR PreCheck website, application and related services (the Service).

The Service is offered only to businesses and people acting for business purposes. It is not offered to consumers for personal use. If you use the Service for an organisation, you confirm that you are authorised to accept these Terms and the Data Processing Agreement for that organisation.

By creating an account, ticking the agreement box at sign-up, or otherwise using the Service after being shown these Terms, you agree to these Terms, the Data Processing Agreement and the Regulatory Disclaimer, and confirm that you have read the Privacy Notice. The Data Processing Agreement forms part of these Terms and takes priority if there is a conflict about the processing of Customer Personal Data.

2. The Service

MLR PreCheck is a business-to-business pre-review drafting aid for Marketing and Marcomms teams working with medical devices and in-vitro diagnostic medical devices. It uses automated analysis, including artificial intelligence, to identify wording that may require evidence, qualification, softening or removal before formal Medical, Legal and Regulatory review and to suggest possible alternative wording.

The Service is not designed for pharmaceutical promotional material, clinical decision-making, patient care, diagnosis, treatment, pharmacovigilance case handling or any patient-facing purpose.

3. Important limitations

The Service is an internal drafting aid only. It does not provide regulatory approval, legal advice, medical advice, clinical advice or a formal MLR decision. It does not guarantee that content is lawful, accurate, supported, approved or suitable for publication.

You remain responsible for checking all output against your approved labelling, intended purpose, evidence, internal procedures and the rules that apply in every intended market. Qualified Regulatory, Medical and Legal personnel must independently review and approve all content before external use.

4. Accounts and authority

You must provide accurate registration details and keep them current. You are responsible for safeguarding login credentials and for activity carried out through your account. Tell us promptly at [email protected] if you suspect unauthorised access.

Workspace owners are responsible for inviting and removing users, assigning appropriate roles and ensuring that users are authorised to access the workspace. We may suspend access where we reasonably believe an account is compromised, misused or in breach of these Terms.

5. Acceptable use

You must not:

• Use the Service unlawfully, fraudulently or deceptively, or infringe another person’s rights.
• Upload material that you are not authorised to disclose or process.
• Attempt to bypass authentication, access controls, usage limits or security measures.
• Reverse engineer or attempt to extract source code, prompts, system instructions or non-public rule content, except where mandatory law permits this.
• Use the Service or its output to build, train, test or benchmark a competing product without our written permission.
• Introduce malware, perform denial-of-service activity, scrape the Service through unauthorised automated means or interfere with normal operation.
• Present output as a formal opinion, certification, clearance, approval or endorsement from MLR PreCheck or any regulator.

6. Data that must not be submitted

The Service is not designed to process the following data, and you must not submit it:

• Patient-identifiable information, personal health information, clinical records, adverse-event reports or pharmacovigilance case data.
• Special-category personal data under UK or EU data-protection law, including health, genetic, biometric, racial or ethnic-origin data, political opinions, religious or philosophical beliefs, trade-union membership or information about a person’s sex life or sexual orientation.
• Personal data about children.
• Full payment-card details or card-security codes.
• Classified, export-controlled or otherwise legally restricted information.
• Confidential third-party information that you are not authorised to disclose.

6.1 Ordinary business contact details

Ordinary professional details such as a business name, job title or work email address are not special-category data. You should still remove them from submitted copy unless they are necessary and you are authorised to use them.

6.2 Accidental submission

You are responsible for redacting or pseudonymising material before upload. If you submit prohibited data by mistake, contact [email protected] promptly. We may restrict access to, isolate or delete material that appears to contain prohibited data.

7. Customer Content and AI processing

You retain ownership of copy, documents, drafts, brand terms and other material you submit to the Service (Customer Content). You grant us a limited, non-exclusive licence to host, copy, transmit, display and process Customer Content only to provide, secure, maintain and support the Service, follow your instructions, and meet legal obligations.

We do not use Customer Content to train our own general-purpose AI models. Customer Content may be sent through a server-side gateway to contracted AI providers solely to produce the analysis requested by you. The current providers and the verified data-use position are described on the Security and Data Protection page.

We do not sell Customer Content. We do not use Customer Content for targeted advertising. Limited security, abuse-prevention and operational logging may occur under the applicable provider terms.

The licence in this section ends when Customer Content is deleted, subject to the limited backup and legal-retention periods stated in the Privacy Notice and Data Processing Agreement.

8. Output and evidence markers

Findings, explanations, severity indicators, suggested wording and final drafts produced by the Service (Output) are advisory. Output may be incomplete, over-cautious, inaccurate or inconsistent. It may resemble output produced for other users and is not guaranteed to be unique.

Marking Evidence available records only the user’s statement that supporting evidence exists. MLR PreCheck does not collect, verify, approve or audit that evidence. The marker is not a substantiation decision and does not replace the customer’s evidence records or approval process.

9. Confidentiality

Each party may receive information from the other that is confidential by its nature or is identified as confidential. The receiving party must use it only for the agreement, protect it using reasonable care and disclose it only to people who need it and are bound by confidentiality duties.

This duty does not apply to information that lawfully becomes public, was already known without restriction, is independently developed, or must be disclosed by law. Personal data is handled under the Privacy Notice and Data Processing Agreement.

10. Intellectual property

The Service, including its software, interface, branding, prompts, rule structure, documentation and related intellectual property, belongs to MLR PreCheck or its licensors. These Terms grant only a limited right to use the Service while the agreement remains in force.

If you upload an organisation logo or branding, you confirm that you are authorised to do so and grant us a limited licence to store and display it within your workspace and branded sign-in page. You can remove it through the available workspace controls.

11. Plans, trials, billing and VAT

Plan features, user limits, usage allowances, billing frequency and price are shown at purchase or in an agreed order. A trial does not require payment unless the sign-up page expressly says otherwise. MLR PreCheck is not currently registered for UK VAT. We do not add UK VAT to the prices charged by MLR PreCheck and we do not issue VAT invoices. If our VAT status changes, we may change future charges after giving reasonable notice. Paid subscriptions renew for the billing period shown at purchase until cancelled. Cancellation takes effect at the end of the current paid billing period unless we agree otherwise. Fees already paid are not refundable except where these Terms or mandatory law require a refund. We may suspend paid access for overdue amounts after reasonable notice.

12. Service availability and changes

We aim to keep the Service available but do not promise uninterrupted or error-free operation and do not provide a service-level commitment unless agreed separately in writing. Availability may be affected by maintenance, security work, internet failures and third-party providers. We may modify the Service. We will give reasonable notice of a material change that removes a core paid feature or materially reduces paid functionality, unless an urgent legal or security reason prevents advance notice.

13. Warranties and disclaimers

To the maximum extent permitted by law, the Service and Output are provided as is and as available. We do not promise that Output is accurate, complete, current, non-infringing, compliant or fit for a particular purpose, or that the Service will identify every issue.

Nothing in these Terms excludes liability that cannot lawfully be excluded, including liability for death or personal injury caused by negligence, fraud or fraudulent misrepresentation.

14. Limitation of liability

Subject to the previous section, neither party is liable for indirect or consequential loss, or loss of profit, revenue, goodwill, anticipated savings, business opportunity or reputation arising from the Service.

Our total liability arising from the Service and these Terms is limited to the greater of the fees paid or payable by the customer for the Service during the 12 months before the event giving rise to the claim, or £500. This limit applies in contract, negligence, breach of statutory duty and otherwise, to the extent permitted by law.

15. Customer responsibility for claims

You are responsible for Customer Content, the legality of your instructions, the evidence supporting your claims, and the decision to use Output. You will reimburse us for losses and reasonable costs arising from a third-party claim caused by your unlawful Customer Content, deliberate misuse of the Service, submission of prohibited data, or presentation of Output as an official approval, except to the extent the claim was caused by our breach of these Terms.

16. Suspension and termination

You may stop using the Service and close your account. Paid cancellation is handled under Section 11. We may suspend or terminate access where you materially breach these Terms, create a security or legal risk, misuse the Service or fail to pay an amount due after notice.

When access ends, Customer Content is returned or deleted as stated in the Data Processing Agreement and Privacy Notice. Sections intended to continue after termination, including confidentiality, intellectual property, liability and dispute provisions, remain effective.

17. Changes to these Terms

We may update these Terms. We will notify registered users of a material change by email or in-app message before it takes effect where reasonably possible. If a material change requires renewed acceptance, the Service must obtain and record that acceptance. If you do not agree, you must stop using the Service before the change takes effect.

18. Governing law and disputes

These Terms and any non-contractual obligations connected with them are governed by the law of England and Wales. The courts of England and Wales have exclusive jurisdiction, except where mandatory law requires otherwise.

19. General

These Terms, the Data Processing Agreement, the Privacy Notice, the Regulatory Disclaimer and any written order form are the complete agreement about the Service. The Data Processing Agreement takes priority for Customer Personal Data. If a provision is unenforceable, the remaining provisions continue. A delay in enforcing a right is not a waiver.

You may not transfer these Terms without our written agreement. We may transfer them with the business or Service, provided the transfer does not reduce your data-protection rights. Nothing creates a partnership, employment relationship or agency between the parties.

20. Contact

Questions about these Terms may be sent to [email protected] or posted to Lee Freeman, a sole trader trading as MLR PreCheck, 54 Chestnut Lane, Ashford, Kent, United Kingdom.