Submission of an application for an interventional clinical study of medical devices to INFARMED, I.P.
An interventional clinical study of medical devices requires an authorization to be granted by Infarmed, or the notification of this same authority, depending on the risk class of the device.
As set out in article 33 of Law No. 21/2014 of April 16, the sponsor should submit a clinical study application to Infarmed.
Online submission via RNEC
The same law defines the National Register of Clinical Studies - RNEC, which includes the electronic system for the submission of clinical studies applications.
All relevant documentation must be submitted via RNEC, as provided in the document "Technical and Functional Specifications", in accordance with article 10 of Ordinance No. 65/2015 of March 5.
Documentation to submit
The sponsor of an interventional clinical study of medical devices shall proceed in accordance with annex VIII (for medical devices) and annex XV (for implantable medical devices) of Decree-Law No. 145/2009 of June 17. In particular, for the interventional pre-market clinical studies of medical devices, by submitting to the Health Products Directorate of Infarmed, via RNEC, the following documents:
- Application for conducting a clinical study of medical devices;
- The "Form for medical devices in clinical investigation";
- The "Statment of clinical investigation with medical devices";
- Clinical investigation plan/protocol;
- The investigator's brochure;
- Informed consent;
- Proof of insurance;
- Labelling and instructions for use;
- The opinion of the CEIC - National Ethics Committee for Clinical Research (if available at the time of submission);
- Up to date CV of the principal investigator of each site;
- Payment guide and receipt of the fee (or, alternatively, proof of exemption from fee payment, in accordance with the provisions of clause 3 of Ordinance No. 63/2015 of March 5).
In the case of medical devices already bearing the CE marking, but that will be used for a different medical purpose other than that refered to in the relevant conformity assessment procedure, it should also be submitted:
- Copy of the CE Declaration of conformity;
- Copy of the labelling;
- Copy of the instructions for use;
- Copy of the CE Certificate (if applicable).
In the case of interventional post-market clinical studies of medical devices, the sponsor must submit all the documents above mentioned (except for the "Statment of clinical investigation with medical devices") as well as:
- Information on relevant data gathered from PMS (post market surveillance plan) and PMCF (post market clinical follow-up).
The sponsor shall keep for a minimum of 5 years for medical devices, and 15 years for implantable medical devices, all the documentation related to the realization and monitoring of the clinical study.
The labelling of medical devices subject to clinical studies should have inscribed the mention "Exclusive for clinical investigation" (as stated on annex I, paragraph 13.5.8 and paragraph 17.2, e) of annex X of Decree-Law No. 145/2009 of June 17).
These devices can only be used within the clinical investigation and under the responsibility of authorized personnel for this same investigation.
Exemption from fees
Ordinance No. 63/2015 of March 5, in its clause 3 provides for the possibility of the Board of Infarmed to grant exemption from the payment of fees regarding the conduct of clinical studies, when the sponsor of studies are non-profit institutions or when dealing with clinical studies of non-commercial nature.
In order to request this exemption the sponsor must, prior to the submission of the clinical study, send an application addressed to the Board of Infarmed, which must attach the statutes of the sponsor' institution. Also, if applicable, a statement signed by the head of the same institution where is clarified that the study in question has no commercial purpose can be submited.
If the request for the exemption from fees was made after the payment, and in the case of a favorable decision by the Board of Infarmed, it should be requested the reimbursement to the Accounting Unit of Infarmed. This request should be supported by documentation.