Covered frameworks
Two active frameworks. The next ones on the way
EryonOne does not claim to know everything. Today, two frameworks are operational - the European MDR regulation and the ANSM doctrine. The rest follows.
Scope
- Technical file: Annex II (documentation) and Annex III (post-market surveillance).
- IFU / user leaflet.
- Labelling and UDI traceability.
- Clinician materials and communication assets.
What EryonOne checks
- Mandatory mentions present and correctly worded.
- Consistency of claims with the clinical evaluation.
- Contraindications and precautions for use documented.
- UDI identification and batch-manufacturer traceability.
- Compliance of technical documentation with annexes II/III.
Active
Medicinal product · France
ANSM · Advertising and promotion of medicinal products
The French national agency for the safety of medicines and health products sets the framework for promotional materials aimed at healthcare professionals. EryonOne covers the applicable doctrine.
Scope
- Promotional materials aimed at healthcare professionals.
- Approvals and doctrinal compliance (claims, comparisons).
- Mandatory mentions (SmPC, benefit/risk balance, legal notices).
- Detail aids, brochures, monographs, e-learning modules.
What EryonOne checks
- Consistency of claims with the SmPC in force.
- Mandatory mentions present and correctly placed.
- Sourced and non-misleading comparisons.
- Balanced benefit/risk in the material.
- Compliance with ANSM recommendations in force.
On the way
The next frameworks
The frameworks listed below are not yet operational. Their integration is planned - the roadmap details the timelines. In the meantime, EryonOne does not check these scopes.
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01
FDA - Code of Federal Regulations 21 CFR
Medicine and medical device regulation in the United States. Scope 21 CFR Part 11 (electronic records) and parts applicable to promotional materials.
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02
EMA - European Medicines Agency
European guidelines on the SmPC, patient leaflet and information materials. QRD (Quality Review of Documents) guidelines.
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03
ICH - International Council for Harmonisation
ICH guidelines applicable to clinical studies: E6 (GCP), E2 (pharmacovigilance), E9 (statistics). For protocols, investigator brochures and clinical reports.
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04
IVDR - Regulation (EU) 2017/746
European regulation on in vitro diagnostic medical devices, complementary to the MDR. Technical documentation and clinical performance.
The order and timelines are indicative. See the product roadmap for delivery dates.
Frequently asked questions
FAQ - Frameworks
What does "active framework" mean?
EryonOne actually checks your document against the requirements of this text. Explicit coverage, scope detailed on the framework sheet.
How is a new framework integrated?
Reading of the text by our RA team, modelling of the applicable rules per document type, validation on a test corpus, deployment. Coverage is published with the exact scope we commit to.
Can I add my own internal frameworks?
Internal frameworks (SOPs, templates, in-house guidelines) are on the EryonCite roadmap, our team platform. On EryonOne, you work with the active public frameworks.
Does EryonOne cover the FDA, EMA, IVDR, ICH?
Not yet. These frameworks are planned and listed above. Prioritisation takes client demand volume into account.
How do I know if my document is well covered?
The exact scope (document types, sections, requirements) is detailed on each sheet. If in doubt, write to us before launching a processing run.
A framework missing?
Tell us, we will look into it
If you work on a framework that does not appear here and is central to your activity, contact the team. The prioritisation of the next frameworks takes client needs into account.