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Requirements for the evaluation of clinical research with medical devices (RD 1090/2015) and their amendments

These are clinical investigations with medical devices that meet the following requirements:

  • Using medical devices that do not carry a CE marking.
  • Using CE-marked medical devices, but these are not used under the authorised and common conditions of use.

Clinical research with CE-labelled medical devices being used under authorised and usual conditions of use (therefore considered observational) will need to be presented as a Research Project (see the Research Project Assessment requirements section). 

CEIm for clinical research with medical devices with a single resolution in Spain (RD 1090/2015)

If you would like our Clinical Research Ethics Committee (CEIm) to be the CEIm for your study, you must send an application email to, indicating the study information and the approximate date or month of presentation.

If not presented on the expected date, you must re-apply and report the new presentation date, as the request is not acted upon unless such a change is reported.

Presentation of the study

Timeframe for study presentation: It can be presented any day of the month. The application must be presented in full.

All documentation may be written in English, except for the following documentation, which must be presented in Spanish

  • Study summary.
  • Patient information leaflet and informed consent.
  • Documentation addressed to the patient.

It must be presented exclusively in digital format via the email address

Requirements for the submission of requests to the CEIm

The requirements set forth in RD 1090/2015 are followed. We attach the documents as a guide for each presentation, with the CEIm requirements stated:


A weekly meeting is usually arranged. The CEIm distributes and organises the presentations validated in the meeting at its discretion, depending on the total entries received, but always following the evaluation calendar, in accordance with RD 1090/2015.

You can refer to our meeting schedule.

Proof of receipt

The CEIm will not issue proof of having received the documentation by email. If you need proof of receipt, request confirmation of receipt.


If you have any queries, contact the CEIm Support Unit:

13th floor of the Hospital Children's Hospital and Women's Hospital 
Passeig Vall d'Hebron n. 119-129
08035 Barcelona
Phone: (+34) 93 489 40 10
Email address:

Contract and billing

To request the contract model, the economic report or any question regarding the contract / economic report: review the Clinical Trials / Contractual and Economic Management section on the Foundation's website.

For any questions regarding invoicing, contact the Department of Economic Management of the Foundation:

Processing of the suitability of the centre

The Vall d'Hebron University Hospital requires signatures from the following:

  • The principal investigator's department head 
  • General Manager of the Vall d'Hebron Research Institute Foundation (VHIR)

To request the signature of the director of the VHIR Foundation, contact the Legal Department of the Foundation: Clinical Trials / Contractual and Economic Management section on the Foundation's website.