When must consentimiento informado be written in Spain?

Under Ley 41/2002 consent is verbal as a rule, and written for surgery, invasive diagnostic and therapeutic procedures and procedures with notable, foreseeable risks. Before written consent the clinician gives the información básica on consequences, risks and contraindications, and the patient can revoke consent in writing at any time.

What the law requires

Consentimiento informado is the patient's voluntary, conscious and unpressured agreement, given after receiving adequate information.¹ The patient has the right to know the available information on any action on their health, and the right not to be told, and the information is given verbally as a rule and recorded in the historia clínica, covering at least the purpose and nature of each intervention, its risks and its consequences.¹ Consent is verbal as a rule and written for surgery, invasive diagnostic and therapeutic procedures and procedures with notable risks, and the patient may revoke it in writing at any time.¹

Before written consent, the clinician informs the patient of the relevant consequences the intervention would certainly cause, the risks linked to the patient's own circumstances, the probable risks in normal conditions and the contraindications.¹ The consent form is part of the historia clínica's contenido mínimo.¹

Cataluña's version

Catalan law asks for specific consent, given voluntarily after information, in writing for surgery, invasive diagnostic procedures and procedures with notable, foreseeable risks, and lets the patient revoke it freely at any time.² Consent forms are among the documents kept at least 15 years from discharge.²

1. Decide whether it must be written. Surgery, invasive procedures and notable risks need a signed form. The rest is verbal and recorded.
2. Give the información básica first. Consequences, personal risks, probable risks and contraindications, in words the patient understands.
3. Record the discussion. What was said, the questions asked and the answer, in the historia clínica.
4. Take the signature. On a form specific to the procedure, dated, before the procedure starts.
5. Honour a revocation. Record it in writing, with the date, and stop.

1. Patient ______ Procedure ______
2. Written consent required ______ Because ______
3. Información básica given by ______ On ______
4. Personal risks discussed ______
5. Form signed on ______ Witness ______
6. Revoked on ______

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Questions

Is verbal consent enough for an aesthetic injection?

Ley 41/2002 requires written consent for invasive procedures and procedures with notable, foreseeable risks, so check whether the treatment is one of them and record the reason either way.

Can a patient withdraw consent?

Yes, at any time, and Ley 41/2002 asks for the revocation in writing.

How long do we keep a consent form?

As part of the historia clínica, at least five years from discharge, and in Cataluña at least 15 years.

Sources

1. 1Boletín Oficial del Estado, 2023Ley 41/2002, de 14 de noviembre, básica reguladora de la autonomía del paciente y de derechos y obligaciones en materia de información y documentación clínica, texto consolidadoRead source
2. 2Boletín Oficial del Estado, 2025Ley 21/2000, de 29 de diciembre, sobre los derechos de información concernientes a la salud y la autonomía del paciente, y la documentación clínica (Cataluña), texto consolidadoRead source

Written by the wai team from Health authorities of the Comunidad de Madrid and Cataluña guidance, checked on 16 October 2026. This is guidance, not legal advice. Neither the Comunidad de Madrid's Consejería de Sanidad nor the Generalitat's Departament de Salut endorses wai or any software.