Public binding texts
Regulations, codes, authority doctrine. They are modelled by our regulatory team, with a published scope. You have nothing to upload.
Today: MDR and ANSM doctrine. Planned: FDA 21 CFR Part 11, ISO 13485, EMA, ICH, IVDR.
Briefing note
What you can upload as a requirement
Public binding texts are on us. What you add here is what is yours alone: your procedures, your charters, the standards you hold a licence for. That pile is what turns a generic review into yours.
Active in EryonOne
On the roadmap
For you to provide
01 Before you upload
Requirement or evidence? The question settles in one sentence.
This is the only thing to understand before you start. The two piles do not serve the same check, and a document filed on the wrong side will not be used the way you expect.
The requirements pile
What your document is allowed to say.
Regulations, standards, procedures, charters, internal rules. Everything that judges the wording, regardless of what it claims.
The evidence pile
What your document has grounds to say.
Publications, evaluation reports, internal data. Everything that supports a specific claim, figure by figure.
The case that catches everyone out
Some documents are both. The SmPC is the textbook example.
It is binding and promotional material must comply with it: that makes it a requirement. It carries the tolerability and posology data: that makes it evidence too. Upload it on both sides. The same goes for an approved leaflet, a clinical evaluation report or a health technology assessment opinion.
02 Who brings what
Three kinds of requirement, three origins.
We do not claim to know everything, and we are not allowed to distribute everything. The split is simple.
Licensed standards
ISO, EN and IEC standards are not freely distributable. We are not allowed to supply them to you. You, on the other hand, have bought your copy.
First check that your licence permits upload to a hosted tool. Failing that, upload the internal procedure that implements it: it belongs to you, and it is often the one that counts.
Your internal frameworks
By definition, only you have them. This is the most useful pile and the least often uploaded: it encodes your doctrine, the one written down nowhere else.
Today our team sets them up for your account. Self-service upload from your own interface is coming.
03 By sector
What other teams upload.
An indicative list, not an exhaustive one. The set that actually applies depends on the exact status of your product and on the target market, which is precisely the first thing to establish. If a document looks borderline to you, send it over and we will tell you whether it is usable.
Your internal frameworks
All sectors · the pile that makes the difference
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To provide
Promotional review charter or approval procedure
Who approves what, in which order, against which criteria.
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To provide
Labelling and leaflet management procedure
In-house mandatory mentions, order of blocks, required formats.
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To provide
Internal medical information rules
What a field response may state, and in what form.
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To provide
Matrix of approved claims, and of prohibited ones
The document that prevents the most arguments.
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To provide
Glossary and mandated terminology
Denominations, abbreviations, units, how values are written.
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To provide
Editorial charter and brand guidelines
Feeds the form axis: structure, headings, typography, footer mentions.
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To provide
Mandatory templates and models
The skeleton expected for each document type.
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To provide
Commitments made to an authority or a notified body
The corrections promised after an audit or an inspection finding.
Medical devices
Manufacturers · authorised representatives · QARA
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Active
Regulation (EU) 2017/745, MDR
Scope covered: technical file (annexes II and III), leaflet, labelling and UDI traceability, clinician materials.
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Planned
Regulation (EU) 2017/746, IVDR
In vitro diagnostics, complementary to the MDR.
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Planned
ISO 13485, quality management system
Document control, review and approval.
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To provide
ISO 14971, risk management
Consistency between the risks identified and what the leaflet says about them.
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To provide
ISO 15223-1, symbols to be used with information supplied
The most mechanical check, and the one most often caught out.
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To provide
ISO 20417, information to be supplied by the manufacturer
Minimum content of labelling and of the leaflet.
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To provide
IEC 62366-1, usability engineering
Legibility and comprehension of the instructions by the intended user.
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To provide
EN ISO 14155, clinical investigation
For protocols and investigator brochures.
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To provide
MDCG guidance applicable to your class
Public documents, to be pinned to the version that concerns you.
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To provide
MedTech Europe Code of Ethical Business Practice
For materials aimed at healthcare professionals.
Medicinal products
Pharmaceutical companies · promotional review · medical affairs
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Active
ANSM recommendations on advertising
Scope covered: promotional materials aimed at professionals, approvals and doctrinal compliance, mandatory mentions, detail aids, brochures, monographs, e-learning modules.
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To provide
French Public Health Code, articles L.5122-1 to L.5122-16
The ANSM doctrine we cover rests on it. Upload the text if you want the report to cite the article rather than the recommendation.
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To provide
Directive 2001/83/EC, title VIII
The European basis for advertising of medicinal products for human use.
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To provide
Approved SmPC, patient leaflet and labelling
Binding and evidence at the same time. To be uploaded in both piles.
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To provide
Promotional information charter and certification framework
The frame for detailing and prospecting.
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To provide
LEEM code of practice, EFPIA code
Industry commitments applicable to your materials.
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To provide
Marketing authorisation scope and internal off-label positions
What the medical team may answer, and where the answer stops.
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Planned
EMA guidelines, including the QRD templates
For the SmPC and the patient leaflet.
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Planned
ICH guidelines
Not covered to date. For protocols and clinical reports.
Cosmetics, food supplements
Product claims · consumer communication
Cosmetics
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To provide
Regulation (EC) No 1223/2009
The general framework for cosmetic products.
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To provide
Regulation (EU) No 655/2013, common criteria for claims
Truthfulness, fairness, evidential support. The central text for a claims review.
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To provide
ARPP recommendation on cosmetic products
For consumer-facing communication.
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To provide
Your product information file and your claim substantiation
On the evidence side: what supports each effect you announce.
Food supplements and foodstuffs
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To provide
Regulation (EC) No 1924/2006, nutrition and health claims
Together with the register of authorised claims.
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To provide
Regulation (EU) No 1169/2011, food information to consumers
Labelling, legibility, mandatory particulars.
Hospitals, laboratories, agencies
Quality · accreditation · service providers
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To provide
HAS certification manual for healthcare establishments
For quality documents, protocols and patient information materials.
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To provide
ISO 15189, medical laboratories
Document control within the accreditation framework.
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To provide
Your procedures, protocols and standard operating procedures
The quality framework as it actually applies at your site.
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To provide
The client's brief
For an agency: the client's rules, on top of your own.
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To provide
The client's approval charter
What your deliverable will be judged on at handover.
04 The most useful one
The document nobody thinks to upload: your past rulings.
Every regulatory team has settled the same questions dozens of times. Those decisions live in email threads, in review comments, and in the heads of two people. They are written in no regulation, and yet they are what carries authority internally.
Upload them. A plain list of “we already settled this, this way, for this reason” is enough. This is the framework that makes a review recognisably yours, and that stops a closed debate from reopening every month.
- “Indirect comparisons are refused, even when sourced.”
- “The word ‘innovative’ is not used without qualifying the innovation.”
- “A subgroup result is always announced as such in the sentence, not in a footnote.”
05 To make it usable
Five points that change the quality of the result.
A badly uploaded framework produces vague findings. These five points take five minutes and save you a disappointing review.
Text, not an image
A digital PDF or an office file. A photographed scan makes it impossible to quote a passage to the line, and therefore impossible to trace a finding back to its source.
A dated version
The one that carries authority at your site, with its date of application. Two versions of the same procedure produce two different verdicts, and that is normal.
Numbering kept
Keep article, section and paragraph numbers. That is what lets the report write “§4.2” rather than “your procedure”.
An extract is enough
If only chapter 4 concerns you, upload chapter 4 with its original pagination. A shorter, relevant text beats a whole corpus.
The point to check before uploading a standard
ISO, EN and IEC standards are licensed. Check that yours permits upload to a hosted tool. If it does not, upload instead the internal procedure that implements it: it belongs to you, it is often more precise than the standard, and it is the one your notified body will ask you to apply.
Unsure about a document?
Send it over, we will tell you whether it is usable
We will tell you whether it works as a requirement, as evidence, or whether it serves no purpose in your case. The analysis starts from the supplied documents alone, and no data is used for training.