Regulatory Disclaimer

1. Purpose of the tool

MLR PreCheck is a pre-review claim-risk assessment tool built specifically for Marketing and Marcomms teams at medical device companies. It identifies wording in draft marketing copy that may require evidence, qualification, softening or removal before formal Medical, Legal and Regulatory review. It covers medical devices and in-vitro diagnostics only. It is not designed for, and must not be relied on for, pharmaceutical, prescription medicine, healthcare services, digital health, cosmetic, supplement or general wellness copy.

Intended use. MLR PreCheck is intended for use by qualified human reviewers as an aid to drafting marketing copy. It is not intended to be, and is not, a medical device under the UK Medical Devices Regulations 2002 or under Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR). It is not intended for any clinical purpose, for diagnosis, monitoring, treatment, prediction, prognosis or alleviation of disease, or for use in any patient-facing setting. Use of MLR PreCheck outside this intended use is your responsibility.

2. No affiliation with regulators

MLR PreCheck is an independent, privately operated tool. It is not affiliated with, endorsed by, sponsored by, certified by, accredited by, partnered with or approved by any government, regulator, competent authority, notified body, standards organisation, trade association or advertising self-regulation body. This includes, without limitation, the US Food and Drug Administration (FDA), the US Federal Trade Commission (FTC), Health Canada, the Competition Bureau of Canada, Ad Standards Canada, the UK Medicines and Healthcare products Regulatory Agency (MHRA), the Advertising Standards Authority (ASA), the Committee of Advertising Practice (CAP), the European Commission, the European Medicines Agency (EMA), any EU Member State competent authority, MedTech Europe, AdvaMed, or any other body referenced anywhere in the Service.

References to laws, regulations, codes of practice or guidance documents are provided solely to describe the frameworks the tool screens against. Use of any regulator or body name, abbreviation, logo, framework citation or quotation within the Service does not imply any relationship, cooperation, recognition or approval. Nothing produced by the Service may be presented to any third party as an endorsement, certification, clearance, approval or other official act of any regulator or body.

3. What MLR PreCheck is not

MLR PreCheck is not:

• a regulatory authority, notified body, competent authority, or accredited certification scheme;
• a substitute for advice from a qualified regulatory affairs professional, lawyer, clinician, pharmacist or medical writer;
• a substitute for your organisation's medical, legal or regulatory (MLR) review process;
• an advertising self-regulation body (e.g. ASA, Ad Standards Canada, MedTech Europe);
• a clinical decision support tool, a medical device under MDR / IVDR, or any form of patient-facing software;
• a guarantee that any content will be deemed compliant, lawful, accurate or fit for purpose by any internal reviewer, regulator, court or third party.

4. No substitute for MLR review

All marketing copy for regulated products must be reviewed and approved by qualified personnel within your organisation, typically through a documented MLR (medical / legal / regulatory) process, and must comply with the laws, codes of practice and approved labelling that apply in each market where the content will be published. MLR PreCheck is an early-stage drafting aid only. Use of the Service does not reduce the scope, depth or independence of that downstream review.

5. Nature of AI output

Findings, rationales and suggested alternative wording are generated by automated AI models. AI output may be:

• incomplete (missing real risks that exist in the text);
• over-cautious (flagging wording that is acceptable in context);
• inconsistent between runs on similar text.

You must treat all output as a starting point for human judgement, never as a final answer. Severity indicators (Red / Amber) are heuristics, not regulatory classifications.

6. Evidence and substantiation

Marking an item as having supporting evidence only records your assertion that such evidence exists. The Service does not collect, validate, version, audit or store that evidence, and the marker is not a substitute for any claim-substantiation, scientific exchange, off-label promotion controls, or pharmacovigilance process. Robust evidence dossiers must be maintained in line with your internal SOPs.

7. Regulatory frameworks

MLR PreCheck assesses copy against current claim-risk principles drawn from major medical device and healthcare advertising frameworks. Depending on your products, geographies and audiences, content you produce may be subject to (without limitation):

• US: FDA 21 CFR Part 801 (labelling) and Part 807 (510(k), "cleared" vs "approved"); broader FDA medical device regulations and guidance on advertising and promotional labelling; FTC Act §5 and the FTC Health Products Compliance Guidance (2022) on substantiation, endorsements and testimonials.
• Canada: Food and Drugs Act; Medical Devices Regulations (SOR/98-282); Health Canada guidance on medical device advertising and licensing; Competition Act and Competition Bureau guidance on misleading representations; Ad Standards Canada Code; bilingual (English / French) labelling and advertising expectations.
• UK: UK Medical Devices Regulations 2002 (as amended, including the post-Brexit amendments); MHRA guidance on medical device advertising and the UKCA / CE marking transition; CAP Code Section 12 (medicines, medical devices, health-related products and beauty products) enforced by the ASA.
• EU: Regulation (EU) 2017/745 on medical devices (MDR), in particular Article 7 on claims; Regulation (EU) 2017/746 on in-vitro diagnostic medical devices (IVDR); subsequent amending regulations including Regulation (EU) 2023/607 on transitional provisions; the EU Unfair Commercial Practices Directive (2005/29/EC); the MedTech Europe Code of Ethical Business Practice. National medical device advertising rules implemented by individual Member States are out of scope and require local review.

MLR PreCheck does not certify compliance with any of the above and does not make country-specific legal decisions. You are responsible for identifying and applying the frameworks relevant to each piece of content and each market in which it is published.

8. Your responsibilities

By using the Service you confirm that you will:

• treat findings and suggested wording as advisory drafting input only;
• route all final content through your formal internal MLR / compliance approval process;
• ensure suggested wording reflects your approved labelling, intended use, indications, contraindications and territory-specific restrictions;
• not submit Prohibited Data (see Terms, Section 6), including patient data;
• not present any MLR PreCheck output, badge or wording as endorsement, certification or approval by a regulator or by MLR PreCheck.

9. Patient data and PHI

The Service is not designed, intended or configured to create, receive, maintain or transmit patient-identifiable data, Protected Health Information ("PHI") as defined by the US Health Insurance Portability and Accountability Act (HIPAA), or equivalent data under UK / EU rules. MLR PreCheck is not a HIPAA Business Associate and no Business Associate Agreement is offered. You must not submit such data to the Service. If you believe such data has been submitted in error, contact us immediately so we can delete it.

10. Limitation of liability

To the maximum extent permitted by law, MLR PreCheck, its providers, personnel and contractors accept no liability for any loss, damage, regulatory action, enforcement notice, complaint, recall, reputational harm or other consequence arising out of or in connection with reliance on the Service or its output. Liability is governed by the limitations set out in our Terms and Conditions.

11. Updates

We may update this Disclaimer to reflect changes to the Service, applicable law or industry guidance. The "Last updated" date above indicates when this Disclaimer was last revised. Continued use of the Service after an update constitutes acceptance of the updated Disclaimer.

12. Contact

Questions about this Disclaimer? Email [email protected].