Submission of an application or notification regarding clinical investigations of medical devices in Portugal
Circular Informativa N.º 006/CD/550.20.001 de 21/06/2021 - Aplicação do Regulamento dos Dispositivos Médicos (RDM) na parte que se refere à investigação clínica de dispositivos.
Documentation to submit
In Portugal, applications and notifications regarding clinical investigations of medical devices shall be sent to INFARMED, I.P.. The submission should be done in electronic format, at the time, through the RNEC.
The sponsor of a clinical investigation of medical devices must submit to INFARMED, IP, as established in Regulation (EU) 2017/745, accompanying it with the documentation referred to in Annex XV, chapter II, following the guide DOCUMENTAÇÃO PARA SUBMISSÃO - Investigações clínicas de dispositivos ao abrigo do Regulamento (UE) 2017/745 - INFARMED, I.P.-CEIC.
The submission must use the standardized folder structure (see Appendix II), and the Formulário do Pedido / Clinical investigation - application form under Medical Device Regulation MDCG_2021-8, available on the website of the European Commission.
MDCG_2021-8_Additional investigational device(s) (section 3) (se aplicável)
MDCG_2021-8_Additional comparator device(s) (section 4) (se aplicável)
MDCG_2021-8_Additional investigation site(s) (section 5) (se aplicável)
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.