Pricing
Pricing per document, per axis, by page volume and, for scientific review, by reference count. Price shown before validation.
EryonOne
Use cases Medical device advertising
Review the advertising for your medical devices before release
Congress roll-up, brochure, product sheet, web page: EryonOne checks the statements the French Public Health Code requires, tests every claim against the device's intended purpose and spots the missing notified body number. For each point, it quotes the passage and the text at stake.
01 Checks
What EryonOne checks, point by point
Six checks drawn from the French Public Health Code, Regulation (EU) 2017/745, ANSM doctrine and your own rules.
Advertising, and for whom
Material that promotes the use of a device is advertising, whatever its title. General public or healthcare professionals: the audience decides which statements are required.
Public Health Code L.5213-1Mandatory statements
For the public: name, intended purpose, manufacturer, invitation to read the IFU, cautionary message, CE marking statement. For professionals: class, notified body, reimbursement status.
Public Health Code R.5213-1, R.5213-2Every claim against the intended purpose
A claimed performance must fit within the intended purpose defined by the manufacturer and assessed for CE marking. Any use suggested beyond it is flagged.
MDR, Article 7The notified body number
As soon as the material cites the CE marking of a device assessed by a notified body, that body's four-digit number must follow.
MDR, Article 20Objectivity and cited sources
No miraculous results, no claim that there are no side effects. Quotations and scientific references are reproduced faithfully, with their exact source.
Public Health Code L.5213-2, R.5213-3Your own rules
Approved claims matrix, editorial charter, glossary: uploaded as requirements, they are checked in the same pass as the official texts.
Your internal requirements
02 Common gaps
The gaps we find most often
On medical device material, the gap is rarely in the main message. It is in what is missing around it, or in an adjective added late.
An intended purpose widened by one adjective
The material suggests a broader use than the one assessed for CE marking, often through a word added in the last round: “all types”, “in every situation”.
MDR, Article 7
“CE marked”, with no notified body number
The headline cites the CE marking, but not the four-digit number of the notified body that must accompany it in any promotional material.
MDR, Article 20
A mandatory statement no one can read
The statement is there, on the back of the brochure or at the foot of the roll-up, in tiny type. The Code requires written statements to be perfectly legible.
Public Health Code R.5213-3
Class or reimbursement status left out
Material for healthcare professionals must state the device class and its reimbursement status under French health insurance.
Public Health Code R.5213-2
A reimbursed device advertised to the public
Advertising to the public is prohibited for devices reimbursed by French health insurance, except those on a list set by order. Perfectly written material is still prohibited.
Public Health Code L.5213-3
A variant that lost its date
Material is duplicated faster than it is corrected: a version carries an old intended purpose, or drops the date of issue the Code requires.
Public Health Code R.5213-1, R.5213-2
03 How it works
A review, end to end
The piece, its references, a few minutes, then your call. The example shows a finding as it appears in the report.
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1You upload the piece and its references
The piece as a PDF, with the IFU, the claimed intended purpose, the CE certificate and, if you have one, your claims matrix.
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2You choose the frameworks and axes
Device class, public or professional advertising, review axes. The price shows before launch: nothing is charged without your approval.
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3EryonOne returns its findings
Within minutes. Each finding quotes the passage, the source and the requirement at stake, with a confidence score.
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4You decide
Accept or dismiss each finding: the decision is kept, and the report exports for your regulatory affairs team.
04 Use cases
Use cases
Manufacturers preparing a congress booth: roll-ups, banners, brochures.
Marketing and regulatory teams rolling out a range across several classes or countries.
Healthcare communication agencies delivering compliant material to manufacturer clients.
05 Limits
An assistant, not an ANSM authorisation
EryonOne is an assistant, not a validator. It grants no advertising authorisation, and the decision to release stays with your regulatory affairs team. The report is working material.
Frequently asked questions
Your questions about this use case
Does my advertising need ANSM authorisation?
Only for certain devices presenting a significant risk, listed by the amended order of 24 September 2012: dermal fillers for the public; among others, implantable cardiac devices, coronary stents, breast implants, joint prostheses and surgical lasers for professionals. Everything else falls under ANSM's after-the-fact control.
Which material can be reviewed?
For now, review runs on PDF; Word and PowerPoint come next. Roll-ups, banners, brochures, product sheets, e-mailings, web pages or decks must therefore be provided as PDF.
Are in vitro diagnostic devices covered?
Yes. Their advertising falls under a separate chapter of the French Public Health Code (Articles L.5223-1 onwards) and Regulation (EU) 2017/746: the medical device grid cannot be reused as is.
Who makes the final decision?
Your regulatory affairs team. EryonOne spots and justifies each point; it does not approve material.
Can you review against our claims matrix?
Yes. Upload it as an internal requirement, with your charter or glossary: the findings that relate to it cite it, like an official text.
How much does a review cost?
The price depends on the number of pages, the axes you choose and, for the scientific axis, the number of references to check. It shows before every launch (pricing), and the first review of a new account is free.
Does my material stay confidential?
Yes. Documents are processed in France, in Roubaix, on a SecNumCloud-qualified OVHcloud offer, and are never used to train a model.