Covered frameworks

The active frameworks and the next ones on the way

EryonOne does not claim to know everything. Today the regulatory review relies on MDR and IVDR by device class, ANSM doctrine, Directive 2001/83/EC, the French Public Health Code and the conditional texts that apply to your file. The two sheets below detail the MDR and ANSM scopes. The rest follows.

Active

Medical devices · Europe

MDR · Regulation (EU) 2017/745

The European medical devices regulation, applicable since May 2021. EryonOne checks documents against its key requirements.

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.

Source text: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices.

Active

Health products · 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 and at the general public.
  • Approvals and doctrinal compliance (claims, comparisons).
  • Mandatory mentions (SmPC, benefit/risk balance, legal notices).
  • Detail aids, brochures, monographs, e-learning modules, and digital assets: websites, product pages, banners, social media, emailing.

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.

Source text: ANSM doctrine on the advertising and promotion of medicinal products. Recommendations of the advertising commission.

The active catalogue

Six groups of texts, selectable when you create a project

An active framework is offered the moment you create a project, and the report can rely on it. The two sheets above detail the MDR and ANSM scopes; the other texts are covered to the scope of their subject.

Active

Medical devices, by class

Regulation (EU) 2017/745 (MDR), broken down by class: I, Is, Im, Ir, IIa, IIb and III.

Active

In vitro diagnostics, by class

Regulation (EU) 2017/746 (IVDR), broken down by IVD class: A, B, C and D.

Active

ANSM doctrine

General doctrine, medicinal product advertising to healthcare professionals and to the general public, advertising online and on social media, advertising of medical devices and IVDs, mandatory particulars, advertising materials, advertising authorisation.

Active

Medicinal products, European framework

Directive 2001/83/EC, the Community code relating to medicinal products for human use, including Title VIII on advertising, and Regulation (EC) No 726/2004 on centralised marketing authorisation.

Active

French Public Health Code

Advertising of medicinal products (L.5122-1 et seq.), of medical devices (L.5213-1 et seq.) and of IVDs (L.5223-1 et seq.), clinical investigations of devices (L.1125-1 et seq.), IVD performance studies (L.1126-1 et seq.).

Active

Conditional texts, depending on the file

Regulation (EU) No 536/2014 on clinical trials of medicinal products and Implementing Regulation (EU) 2021/2226 on electronic instructions for use of medical devices.

What you add

Your frameworks matter as much as ours

We take care of the public, binding texts. What you add is what is yours alone, and that stack is what turns a generic review into yours.

The requirements pile

What your document is allowed to say.

Regulations, standards, procedures, charters. What judges the wording.

The evidence pile

What your document has grounds to say.

Publications, evaluation reports, internal data. What backs a figure.

Some documents are both: the SmPC is binding, and it carries the tolerability and posology data. Upload it on both sides.

01 Your procedures and charters

Promotional review charter, labelling procedure, internal medical information rules, review and approval workflow.

02 Your content rules

Approved and prohibited claim matrix, glossary and mandated terminology, editorial charter, required templates.

03 Standards you hold a licence for

ISO 14971, ISO 15223-1, ISO 20417, IEC 62366-1. We are not allowed to distribute them: check that your licence permits uploading, otherwise upload the internal procedure that transposes it.

04 Your past rulings

The document nobody thinks of uploading, and the most useful one: the list of what you have already settled, and why.

Today our team sets your frameworks up for your account; self-service upload is coming. See the full list by sector, from medical devices to food supplements.

On the way

The next frameworks

The frameworks listed below are not covered yet. The FDA is being integrated; the next three are prioritised according to client demand. In the meantime, EryonOne does not check these scopes.

  • 01

    FDA (Code of Federal Regulations 21 CFR)

    Medicine and medical device regulation in the United States, currently being integrated. Intended scope: 21 CFR 202.1 (prescription drug advertising), 21 CFR 801 (device labelling) and 21 CFR Part 11 (electronic records).

  • 02

    ISO 13485 (quality management system)

    Document control, review and approval of documents, for medical device manufacturers. Prioritised alongside the FDA on the roadmap.

  • 03

    EMA (European Medicines Agency)

    European guidelines on the SmPC, patient leaflet and information materials. QRD (Quality Review of Documents) templates.

  • 04

    ICH (International Council for Harmonisation)

    ICH guidelines applicable to clinical studies: E6 (good clinical practice), E2 (pharmacovigilance), E9 (statistics). For protocols, investigator brochures and clinical reports.

The order is indicative. The product roadmap places the FDA and ISO 13485; the EMA and ICH have no committed date.

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. Once live, each framework's source is monitored automatically: if the text changes, the team is alerted.

Can I add my own internal frameworks?

Yes. A SOP, a review charter, a labelling procedure, a standard you hold a licence for: these documents frame the review around your own requirements. Today our team sets them up for your account; self-service upload is coming. The sector-by-sector list says what can be uploaded. Not to be confused with your scientific references, which you already attach to each project yourself.

Does EryonOne cover the FDA, EMA, ICH, ISO 13485?

Not yet. These frameworks are planned and listed above; the roadmap places the FDA and ISO 13485. The IVDR is already active: the four IVD classes are selectable. 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.

Write to us See the roadmap

More about EryonOne

What AI-assisted review changes

What AI-assisted review changes for a regulatory affairs team: spot, justify, arbitrate. The decision stays with your team.

The requirements you can upload

Procedures, charters, claim matrices, licensed standards: the sector-by-sector list of documents to upload as requirements in EryonOne.

The product roadmap

What is shipped, in progress and planned in EryonOne: dated releases, upcoming work announced by quarter.