How do you declare an EIGS to the ARS and handle complaints in France?

Declare a serious adverse event associated with care to the ARS without delay on the national portal, then send its analysis as volet 2 within three months. Complaints go first to the establishment and its Commission des usagers, and the ARS can be asked when that fails.

What an EIGS is and who declares it

An EIGS is an unexpected event associated with care with serious consequences, such as death, a threat to vital functions or a risk of lasting harm. Articles L.1413-14 and R.1413-68 of the Code de la santé publique set the duty for health professionals. In an establishment the declaration is made under its legal representative, and a professional may declare directly when transparency is lacking.¹ Declarations go through the national portal, which sends them to the ARS.²

Two declarations, three months apart

1. Secure the patient and the facts. Immediate management first, then preserve the record as it stood.
2. Send volet 1 without delay. On the national portal, ticking the box for the first part of an EIGS declaration, and keep the reference it gives.
3. Tell the patient. HAS expects professionals trained to announce harm associated with care, and the référentiel 2027 adds a criterion on informing the patient.
4. Analyse within three months. A collective analysis with the teams, using the methods HAS promotes, with support from the regional support structure if needed.
5. Send volet 2. On the portal, with the volet 1 reference, no later than three months after volet 1.
6. Feed it back. Share contributing factors and the action plan with professionals and user representatives.

1. Date and time of the event ______ Service ______
2. Consequence ______ Unexpected, yes or no ______
3. Volet 1 sent on ______ Portal reference ______
4. Patient informed on ______ By ______
5. Analysis led by ______ Contributing factors ______
6. Volet 2 sent on ______ Actions and owners ______

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HAS received 4,630 EIGS declarations in 2024, 13% more than in 2023, and 16,060 since March 2017, and still considers them heavily under-declared.³ In Provence-Alpes-Côte d'Azur the ARS names PASQUAL as its regional support structure for the analysis.¹ Certification checks the same chain, since criterion 3.1-04 is an impératif.⁴

Complaints, through the CDU

Every public and private health establishment has a Commission des usagers, with the legal representative, a medical and a non-medical mediator and two user representatives. It is informed of every complaint and its outcome, and of serious adverse events and the actions taken.⁵ A complainant may bring a user representative to the meeting with the mediator.⁵ Where the establishment does not answer, the ARS can be asked, and inspections may follow a complaint.⁶

Questions

Where do we declare an EIGS?

On the national portal for adverse health events, which sends the declaration to your ARS. It is the required channel for both parts.

Does a private practice have to declare an EIGS?

Yes. The duty under article L.1413-14 falls on health professionals, whether or not they work in an establishment.

Who sits on the Commission des usagers?

At least the legal representative, a medical mediator, a non-medical mediator and two user representatives, each with a substitute, and user representatives serve three-year terms.

Sources

1. 1ARS Provence-Alpes-Côte d'Azur, 2024Signaler un événement indésirable grave associé aux soins (EIGS)Read source
2. 2Ministère chargé de la santé, 2026Portail de signalement des événements sanitaires indésirablesRead source
3. 3Haute Autorité de santé, 2025Évènements indésirables graves associés aux soins (EIGS), rapport annuel 2024Read source
4. 4Haute Autorité de santé, 2025Référentiel, Certification des établissements de santé pour la qualité des soins, version 2025Read source
5. 5ARS Île-de-France, 2025Commissions des usagers (CDU)Read source
6. 6ARS Centre-Val de Loire, 2025L'inspection-contrôle des établissements sanitaires et médico-sociaux, comprendre le rôle des ARSRead source

Written by the wai team from Haute Autorité de santé guidance, checked on 16 October 2026. This is guidance, not legal advice. Neither HAS nor any ARS endorses wai or any software.