PORTUGAL Law and Practice Contributed by: Eduardo Nogueira Pinto, Hugo Monteiro de Queirós, Eliana Bernardo and Ricardo Rocha, PLMJ
ongoing trials will have to be transferred to the CTIS under the Clinical Trials Regulation. Medical Devices The rules regarding clinical studies of medical devices are found in Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices and in DL 29/2024, implementing MDR in Portugal. In Vitro Medical Devices The legal rules applicable to clinical studies of in vitro medical devices are established in Regula- tion (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices (IVDR) and in the Clinical Trials Law. 2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial Medicines Since 31 January 2025, authorisation to conduct a clinical trial of medicine needs to be obtained through the CTIS, pursuant to the Clinical Trials Regulation. Applications for clinical trials in the EU and the European Economic Area must be submitted under the CTIS, under the terms provided by Regulation (EU) 536/2014 of the European Par- liament and of the Council of 16 April 2014 on clinical trials of medicinal products for human use. In this case, applications must be submit- ted through the CTIS, and the sponsor should propose a reporting member state that will be responsible for the analysis of the application. Medical Devices Applications to conduct clinical investigations as defined in the MDR must be submitted by the sponsor to the member state(s) where the clini- cal investigation will be conducted. The applica-
tion must be submitted through the electronic system referred to in the MDR, accompanied by the documents referred to in Chapter II of Annex XV of the MDR. 2.3 Public Availability of the Conduct of a Clinical Trial Clinical trials of medicines and clinical studies of medical devices are available on the National Clinical Trials Register website at www.rnec.pt. The results of clinical trials and clinical studies of medical devices are not available in publicly accessible databases. 2.4 Restriction on Using Online Tools to Support Clinical Trials The recruitment methods for clinical trials of medicines and clinical studies of medical devic- es must follow the legally prescribed rules. In addition to physical advertising methods, digi- tal means can be used for this purpose. These means may also be used for monitoring pur- poses, provided that they do not jeopardise the purpose and safety of the trial. 2.5 Use of Data Resulting From Clinical Trials Data from clinical trials of medicines and clinical studies of medical devices may qualify as per- sonal data in the sense of sensitive data. Howev- er, if the data is fully anonymised (and not merely pseudonymised), it is no longer personal data, and subsequently, it does not fall within the cat- egory of sensitive data. Anonymisation implies that the data subject’s identity is unobtainable, which makes the data anonymous. If the data resulting from processing is still clas- sified as personal data, it may be shared with third parties or affiliates. However, this transfer must adhere to the requirements of the Gen- eral Data Protection Regulation (GDPR). This
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