Submission of a clinical investigation of medical devices in Portugal

 

The application of a clinical investigation, or the notification of a post-marketing clinical follow-up investigation, is submitted electronically through the European database on medical devices (EUDAMED).

In Portugal, until EUDAMED is fully operational, applications and notifications regarding clinical investigations of medical devices must be submitted to INFARMED, I.P. The submission must be made electronically through the RNEC (National Register of Clinical Investigations).

 

Documentation to submit

The sponsor of a clinical investigation of medical devices must submit the process to INFARMED, IP, as established in Regulation (EU) 2017/745, accompanying it with the documentation referred to in Annex XV, Chapter II.

 

Until EUDAMED is fully operational, the European Commission has defined provisional alternatives and published a series of documents to support the submission of clinical research procedures. These documents, including the Application Form / Clinical investigation - application form under Medical Device Regulation MDCG_2021-8, available on the European Commission website, were developed to meet the requirements of Annex XV.

In Portugal, Infarmed and CEIC work in a coordinated manner, and in addition to adopting the referred documents, maintain a checklist of documents, which has proven to be a good practice over the past few years, bridging Annex XV and EN ISO 14155: DOCUMENTATION FOR SUBMISSION - Clinical investigations of devices under Regulation (EU) 2017/745 - INFARMED, I.P.-CEIC.

Further supporting information can be found in the Infarmed guide Orientações regulamentares para Investigações clínicas de dispositivos médicos - submissões em Portugal, developed for sponsors.