Clinical investigations with medical devices should be performed by health care professionals with scientific and medical qualifications and appropriate experience, preferably in the proposed research area. Everyone involved in clinical research must follow Good Clinical Practice (GCP) specified in the international standard ISO 14155:2020, the EU MDR 2017/745 and other relevant scientific MDCG guidelines provided by the European Commission.
With the implementation of the European Medical Device Regulation (MDR), the scientific and medical community is been presented with a safer and more stringent regulatory scenery that aims to protect the society and European patients. Moreover, in the interest of ensuring that the clinical investigation is scientifically and ethically sound, each Member State may have specific requirements to ultimately approve the investigation.
Clinical research in Portugal
Over the past years there we have seen an increased international interest in setting up clinical investigations in Portugal. This is mainly due to highly qualified and specialized hospital research staff and an affordable health care pricing system. In Portugal, there is also an increase in public-private partnership projects; driven by the increased demand on high quality and up-to-date healthcare services. This also impacts context of clinical investigations, and opens up the market for the possibility to perform more complex clinical studies.
For Sponsors that already know the Spanish medical research community, they will find that the Portuguese economic environment and culture, medical and legal system, and competitors are very similar as in Spain. In addition to that, Portugal is a nice niche market to be explored due to a favourable clinical research climate.
In Portugal, the CEIC and Infarmed correspond to the National Ethics Committee and the National Competent Authority, respectively. In our company we have unique hands-on experience with submissions to CEIC and Infarmed.
- CEIC (Comissão de Ética para a Investigação Clínica)
- Infarmed (Autoridade Nacional do Medicamento e Produtos de Saúde, I. P.)
The CEIC (the ethics committee) acts as a judge to protect the wellbeing of the participants, and therefore obtaining a favourable opinion on their behalf before conducting any clinical trial is mandatory. The need to submit the trial proposal to the Infarmed (competent authority) depends on the commercial status of the product and the content of the investigation.
For carrying out any clinical investigation, the interested party needs to provide proof of concept and a solid study design to back up the proposal; the safety and awareness of a medical product depend on the amount and quality of the evidence that supports it.
Products pending their CE-mark, or those that are already on the market but the Sponsor aims to commercialize it for an intended use different from the original, will have scarce data to build a solid foundation for market release. In these cases, Infarmed and CEIC will demand the highest level of requirements to safeguard, to the fullest possible extent, the wellbeing of the participants and society as a whole.
Notably, each Member State also reserves the right to request any additional document or rationale that they consider appropriate for their ethical and scientific evaluation.
It is common that Portuguese authorities will reply with comments after the initial submission. This is standard approach and nothing to worry about! The best course of action is to comply as closely as possible with their requirements, so all their doubts and concerns are cleared out and they decisively approve the study to move forward.
Obtaining a CEIC and Infarmed favourable opinion will mostly take several months. However, an advantage is that submissions to both authorities may be performed simultaneously through an electronic portal. The National Registry for Clinical Studies (RNEC) is a tool for registry and publication of all Portugal undergoing clinical studies that involve human beings.
The RNEC portal takes the place of EUDAMED until its full release. The portal allows a better interaction with all stakeholders and facilitates the transmission and monitoring of information for authorization and notification of the corresponding authorities. RNEC also provides access to the research community, healthcare professionals, and society to all clinical studies carried out in Portuguese territory.
Work with the experts
In AKRN we work hand in hand with our clients to achieve their clinical development objectives. We combine our expertise and commitment to guide our clients throughout the sophisticated regulatory submission journey. Our team is highly experienced in carrying out clinical investigations around the European Union and we understand that the submission to the Portuguese authorities can be one of the most challenging deliverables in the process of starting up a European clinical investigation.