PORTUGAL Law and Practice Contributed by: Eduardo Nogueira Pinto, Hugo Monteiro de Queirós, Eliana Bernardo and Rúben do Carmo Pereira, PLMJ
2.2 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 Euro- pean Economic Area must be submitted under the CTIS, under the terms provided by Regulation (EU) 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials of medici- nal products for human use. In this case, applications must be submitted through the CTIS, and the sponsor should propose a reporting member state responsible for analysing 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 clinical investigation will be conducted. The application 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 med- ical devices are available on the National Clinical Trials Register website at www.rnec.pt. The results of clini- cal trials and clinical studies of medical devices are not available in publicly accessible databases. Access to clinical trials of medicines is also availa- ble on CTIS, where results from completed trials are already available (www.euclinicaltrials.eu). 2.4 Use of Online Tools to Support Clinical Trials The recruitment methods for clinical trials of medi- cines and clinical studies of medical devices must fol- low the legally prescribed rules. In addition to physi- cal advertising methods, digital means can be used for this purpose. These means may also be used for monitoring purposes, provided they do not jeopardise the trial’s purpose and safety.
Medical devices and IVMD are also subject to different classifications depending on their risk and the need for monitoring by healthcare professionals.
2. Clinical Trials 2.1 Regulation of Clinical Trials
Different pieces of legislation regulate clinical trials of medicines and clinical studies of medical devices. Medicines Regulation regulates clinical trials of medicines (EU) 536/2014 of the European Parliament and of the Coun- cil of 16 April 2014 (“Clinical Trials Regulation”) and Law 21/2014 of 16 April 2014 (“Clinical Trials Law”). The entry into force of the Clinical Trials Regulation on 31 January 2022 also introduced the Clinical Trials Information System (CTIS), through which all clinical trial submission, assessment and supervision pro- cesses in the EU are to be submitted. The three-year transition period under the Clinical Trials Regulation has elapsed on 31 January 2025, after which all ongo- ing trials must be transferred to the CTIS. Medical Devices The rules regarding clinical studies of medical devices are found in the MDR, as implemented in Decree-Law 29/2024 in Portugal. In addition, Law 71/2025 of December 22 introduced a set of provisions into Portuguese law to implement MDR for clinical investigations and performance stud- The legal rules applicable to clinical studies of in vitro medical devices are established in IVMDR and in the Clinical Trials Law. In addition, Law 71/2025 of December 22 introduced a set of provisions into Portuguese law to implement IVMDR, including provisions on clinical investigations and performance studies of IVMD. ies of medical devices. In Vitro Medical Devices
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