Building an approved claims matrix: the method

The same claim rarely travels in a single form. It starts life in a CE marking file, a clinical evaluation report or an SmPC. It is reworded in a brochure, shortened in an email campaign, translated for a congress, then reused two years later by someone who never read the source. An approved claims matrix exists to stop that drift. It is a single internal reference that ties every message to its evidence, its scope of use and its status. Here is how to build one, keep it alive and use it during review.

Why a matrix rather than a list of messages

Many teams already keep a list of approved messages. It ages badly: it records what was accepted one day, without saying by whom, on what evidence, for which product and for which audience. Six months later, nobody knows whether the sentence still holds after the leaflet was updated.

A matrix does something else. Each row is a decision, and the columns keep the reasons behind it. The benefit is immediate.

• Reviewers stop relitigating the same arguments on every piece of material.
• Marketing teams know what they may write, and on what conditions.
• When a source changes, one search returns every message depending on it.

What regulation requires behind every claim

The matrix invents nothing: it organises requirements that already exist.

For medicinal products, Directive 2001/83/EC requires that all parts of the advertising comply with the particulars listed in the summary of product characteristics (Article 87(2)) and that it presents the product objectively, without exaggerating its properties (Article 87(3)). Article 92 adds that documentation sent to healthcare professionals must be accurate, up to date, verifiable and sufficiently complete, and that quotations and tables taken from publications must be faithfully reproduced with the precise sources indicated. Under French law, Article L.5122-2 of the French Public Health Code further requires compliance with the terms of the marketing authorisation and with the therapeutic strategies recommended by the Haute Autorité de santé.

For medical devices and IVDs, Article 7 of Regulation (EU) 2017/745 and Article 7 of Regulation (EU) 2017/746 prohibit any text, name, trade mark, picture or sign that may mislead the user or the patient about the device's intended purpose, safety and performance, in particular by ascribing functions and properties the device does not have, or by suggesting uses other than those covered by the conformity assessment. Article L.5213-2 of the French Public Health Code requires the device to be presented objectively, together with its performance and its conformity with the general safety and performance requirements as attested by the EU declaration of conformity.

The ANSM spells out what substantiation means, in its recommendations on advertising for devices and IVDs: objective data that are relevant to French medical practice, a full bibliographic reference (author, title, journal, year, volume, pages or DOI), identification of unpublished sources by date and study number, and references kept available to anyone who asks for them.

Three consequences follow: evidence must be cited, scope must be bounded, references must stay reachable. Those are the columns of the matrix.

The columns of an approved claims matrix

Four blocks of columns are enough.

The core

• a stable identifier that survives changes of wording;
• the exact approved wording, written as it will be published;
• the short variants allowed, strapline, subheading, banner;
• the wordings that were rejected, with the reason for refusal.

The evidence

• the type of source: SmPC, instructions for use, technical documentation, clinical evaluation report;
• the full reference and its precise location, section, page or table;
• the date of the version cited;
• where the document sits internally.

The scope

• the product, its version, its commercial reference;
• the indication or intended purpose claimed, and the population concerned;
• the country, the audience (healthcare professionals or the general public) and the channel, print, website, social media or congress;
• the languages in which the claim is approved.

The life cycle

• the status: approved, approved with conditions, suspended, withdrawn;
• the approval date, the scheduled review date and the named owner;
• the version history.

Writing the claim itself

One row, one assertion. As soon as a sentence carries two ideas, split it: otherwise the evidence covers only half the message, and review can no longer settle the point.

Write the publishable sentence, not a summary of it. Reduces pain and reduces pain at four weeks in adults do not call for the same evidence. Keep the device's intended purpose, or the medicinal product's indication, separate from the benefit claim that follows from it.

Comparisons deserve separate handling. The ANSM asks that compared products be identified, that the criteria used be material, relevant and verifiable, and that results be presented in the same units and on the same scales. Where a claim rests on a study of an earlier generation of the device, equivalence must have been demonstrated in the CE marking file, and the generation studied stated explicitly.

Finally, record whatever must travel with the claim: mandatory particulars, warnings, bibliographic footnote. An accurate claim becomes misleading once its context is dropped.

Governance: who decides, who arbitrates

A matrix without an owner turns back into a dead spreadsheet within a quarter. Four rules prevent that.

• A named owner per row, a person and not a department.
• A joint committee, regulatory, medical and marketing, meeting on a fixed date and clearing the pending requests.
• A single point of entry: any request for a new claim arrives with its evidence attached, or it is not processed.
• Written decisions, refusals included, with their reasons, so the same debate does not resurface on the next piece of material.

Read access stays wide, write access narrow. A matrix that is locked down or impossible to find protects nothing.

Keeping the matrix alive

Updates are triggered by events, not by goodwill. The triggers are well known: a new version of the SmPC or the leaflet, an update to the clinical evaluation report or the PSUR, a new or retracted publication, a change in ANSM doctrine, a new market, an added language.

Add a dated periodic review, even when nothing has happened. And never overwrite a row: version it. A withdrawn claim stays visible, with its withdrawal date and reason, because printed material keeps circulating.

Translate the matrix, not only the documents. The claim approved in English is almost never the literal translation of the French one: it has its own evidence and its own scope.

In practice

An approved claims matrix is only worth what its use in review makes it worth. When drafting, you start from the row and stay on it. When checking, you look for unlisted variants, evidence that has expired and the claims that have drifted out of scope.

At that point the matrix becomes a review reference, on the same footing as an SOP or a code of practice. At Eryon, our clients submit this kind of internal requirement alongside the regulatory frameworks we cover, and EryonOne checks every passage of the document against both, quoting the exact extract and the reference text. The report remains working material: the decision to accept or set aside belongs to the expert.