Real Decreto 192/2023 establishes Spain’s national requirements for medical devices and develops the areas of Regulation (EU) 2017/745 that remain subject to national law. For clinical investigations, Articles 30 to 34 regulate ethical review, AEMPS authorisation, Spanish-language documentation, investigational-device supply, insurance, liability and studies involving CE-marked devices.
The requirements that apply depend on whether the investigation is conducted to demonstrate conformity under MDR Article 62, involves a CE-marked device outside its intended purpose under Article 74(2), qualifies as a PMCF investigation under Article 74(1), or falls within Article 82. Correct classification determines whether prior AEMPS authorisation, notification or consultation is required.
What Real Decreto 192/2023 Adds to the EU MDR
The EU MDR provides the general European framework for medical device clinical investigations. Real Decreto 192/2023 does not replace that framework. It establishes the national requirements that sponsors must satisfy when an investigation is conducted in Spain.
These include the role of the Spanish Research Ethics Committee for medicinal products, or CEIm, the conformity of participating-site management, the responsibilities of AEMPS, Spanish-language requirements, investigational-device supply controls and the national insurance and liability regime.
For multinational investigations, the Spanish requirements must therefore be incorporated into the European regulatory strategy, study documentation, site activation plan and insurance arrangements.
Articles 30 to 34 at a Glance
| Article | Subject | Practical implication |
|---|---|---|
| Article 30 | Ethical, methodological and operational requirements | Requires a favourable CEIm opinion, site management conformity, controls over investigational-device supply and retention of the Annex XV documentation. |
| Article 31 | AEMPS authorisation procedure | Requires the sponsor to apply to AEMPS and submit the application and specified study documents at least in Spanish. |
| Article 32 | Compensation for injury | Makes the sponsor responsible for arranging insurance or an equivalent financial guarantee before the investigation begins. |
| Article 33 | Liability regime | Defines compensable harm, the presumption of causation and the minimum and maximum guaranteed amounts. |
| Article 34 | CE-marked devices and other investigations | Establishes how the national requirements apply to MDR Article 74(1), Article 74(2) and Article 82 investigations. |
These provisions must be read together. Article 32 establishes the obligation to arrange coverage, while Article 33 defines the associated liability regime and guaranteed amounts. Article 34 determines which of the preceding provisions apply to investigations involving CE-marked devices and other study categories.
CEIm Review and Participating-Site Approval
A medical device intended for a clinical investigation may only be made available to investigators after the investigation has received a favourable opinion from an accredited Spanish CEIm. The management of each participating site must also provide its conformity.
For multicentre investigations, one CEIm in Spain issues a single, binding opinion covering the participating centres. The same ethical-review requirement applies to substantial modifications.
Site management conformity is normally documented through the agreement between the sponsor and each participating centre. Sponsors should coordinate the CEIm review, site contracts and AEMPS process because they may progress in parallel but remain separate prerequisites for study initiation.
Study design and conduct should also follow the Good Clinical Practice principles explained in our guide to ISO 14155:2026 for medical device clinical investigations.
AEMPS Authorisation and Spanish-Language Documents
Investigations conducted to demonstrate conformity under MDR Article 62 require prior authorisation from AEMPS. The same authorisation pathway applies when a CE-marked device is investigated outside its intended purpose under Article 74(2).
Under Article 31, the application, Investigator’s Brochure, Clinical Investigation Plan, informed-consent documentation, instructions for use and investigational-device labelling must be submitted at least in Spanish.
Article 30 also requires the labels and instructions accompanying investigational devices to be available at least in Spanish and to allow the devices to be clearly identified at all times.
These requirements should be addressed during document planning. Sponsors should not assume that an English Investigator’s Brochure or Clinical Investigation Plan will be sufficient for a Spanish submission.
Investigational-Device Supply and Documentation
As a general rule, the sponsor must provide investigational devices free of charge. AEMPS may authorise another form of supply in specific circumstances, and unused devices must be returned to the sponsor after the investigation.
Hospital pharmacy services supervise the supply of investigational devices when the investigation is conducted in a hospital. For investigations conducted outside a hospital, a person must be designated to perform this supervisory function.
The sponsor must retain manufacturing and batch-control protocols in the trial master file. A sponsor or legal representative established in Spain must also keep the documentation required under MDR Annex XV available to the competent authorities for the applicable retention period.
Insurance, Compensation and Liability
Articles 32 and 33 regulate related but distinct obligations.
Article 32 requires the sponsor to ensure that insurance or an equivalent financial guarantee has been arranged before the investigation begins. The coverage must address injury suffered by participants and the potential liabilities of the sponsor, principal investigator, collaborating investigators and participating hospital or centre.
Article 33 establishes a rebuttable presumption that harm affecting a participant’s health during the investigation and during the year following the end of treatment was caused by the investigation. After that period, the participant must demonstrate the causal relationship between the investigation and the harm.
The minimum guaranteed amount is €250,000 per participant. A maximum insured amount or financial guarantee of €2,500,000 may be established per clinical investigation and year.
Sponsors should verify that the policy wording, covered parties, territorial scope, study period and guaranteed amounts correspond to the final investigation design and participating sites.
How the Rules Apply to CE-Marked Devices
| Investigation type | Effect under Real Decreto 192/2023 |
|---|---|
| CE-marked device used outside its intended purpose, MDR Article 74(2) | Articles 30 to 33 apply. Prior AEMPS authorisation, favourable CEIm opinion and site management conformity are required. |
| CE-marked device used within its intended purpose with additional invasive or burdensome procedures, MDR Article 74(1) | Notification to AEMPS is required at least 30 calendar days before the investigation begins. Until the applicable EUDAMED module is available, notification is made through NEOPS. |
| CE-marked device used within its intended purpose without additional invasive or burdensome procedures | AEMPS authorisation or notification is generally not required, although CEIm review and site management conformity must still be considered. |
| Other clinical investigation under MDR Article 82 | Article 30 applies with the exception specified in Article 34. Sponsors should consult AEMPS to determine whether additional Article 62 requirements or authorisation will apply. |
The distinction between Article 74(1) and Article 74(2) is particularly important. An Article 74(1) communication is a notification rather than an authorisation procedure. An investigation outside the CE-marked intended purpose follows the full authorisation pathway.
Real Decreto 192/2023 and the AEMPS Submission Process
Real Decreto 192/2023 establishes the national legal obligations. It does not contain all the operational forms, submission routes and administrative instructions needed to prepare an application.
Sponsors should use the current AEMPS instructions to confirm the applicable pathway, submission route, forms, supporting documents, fees and review process. Our practical guide to AEMPS clinical investigation submissions in Spain explains these operational requirements separately.
Keeping these two resources separate avoids mixing legal interpretation with step-by-step submission instructions: this article explains what the Royal Decree requires, while the AEMPS guide explains how to prepare and submit the application.
MDx CRO supports medical device sponsors with Spanish regulatory strategy, CEIm and AEMPS submissions, document preparation, site activation, monitoring, safety management and clinical investigation delivery. Explore our MedTech Clinical Solutions or contact our Clinical Research team to discuss an investigation planned for Spain.
Frequently Asked Questions
Real Decreto 192/2023 establishes Spain’s national rules for medical devices. Articles 30 to 34 address medical device clinical investigations, including CEIm review, AEMPS authorisation, Spanish-language documentation, investigational-device supply, insurance, liability and investigations involving CE-marked devices.
No. Article 62 and Article 74(2) investigations generally require prior AEMPS authorisation. Certain Article 74(1) investigations require notification through NEOPS, while some studies involving CE-marked devices within their intended purpose require neither authorisation nor notification. CEIm review and site management conformity must still be considered.
For an authorisation application, the application, Investigator’s Brochure, Clinical Investigation Plan, informed consent, instructions for use and investigational-device labelling must be submitted at least in Spanish.
The sponsor must arrange insurance or an equivalent financial guarantee covering participant injury and the relevant liabilities before the investigation begins. The minimum guaranteed amount is €250,000 per participant, with a permitted maximum insured amount or financial guarantee of €2,500,000 per investigation and year.
It depends on the intended use and study procedures. Use outside the CE-marked intended purpose normally requires full AEMPS authorisation. Use within the intended purpose with additional invasive or burdensome procedures generally requires notification at least 30 days before study initiation.
