Requirements for the evaluation of clinical research with medical devices and their amendments

A clinical investigation with a medical device (RD 192/2023) must meet the following requirements:

Medical device without CE marking.
Medical device with CE marking, but used outside authorised and usual 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).

If you wish our CEIm to be the evaluator of the study, you have to request our action via email at ceic@vhir.org indicating the scheduled date or the most likely date of submission, as well as the general data of the trial:

Title
Codes
Promoter
CRO
Centres
Participating PIs

If the application is not submitted by the deadline, the CEIm has to be notified, and a new application for a new action has to be submitted along with the new date of submission. The application is not automatically shifted from one month to the next.

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 ceic@vhir.org.

Initial submission and relevant amendments:

We follow the requirements set out by the AEMPS which are included in Annexes A and B of their website.

Initial application - PS
Application for relevant amendments
Information on Immediate Application Amendments and Study Halt

Evaluation

The CEIm meets on a weekly basis, except for long weekends and public holidays.

The validated submissions will be distributed at the meeting deemed suitable according to the total entries received, but always complying with the evaluation calendar specified in 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.

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: facturacion@vhir.org.

Processing of the suitability of the centre

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

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

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