NLMedicalDevices object

Act on Medical Devices (or comparable national legal framework)

Decree-Law No. 145/2009, 17 June as amended, concerning medical devices and active implantable medical devices/ Decreto-Lei n.º 145/2009, de 17 de Junho, hereafter referred to as 'DL 145/2009 (pt)'.

It is the transposition of Directives 93/42/CEE, 90/385/CEE and 2007/47/CE into national law.

Other applicable regulations / implementing provisions (Acts, laws, decrees, ordinances, circulars, etc)

(1) Law on clinical research
Law 21/2014 (pt), published 16 April 2014 in the Official Gazette (Diário da República): repeals Law 46/2004 of 19 August 2004 (Clinical Trials on Medicinal Products for Human Use) that incorporated the principles of the Clinical Trials Directive 2001/20/EC.
This law covers all clinical research with humans including not only clinical trials with IMP but also investigations with MD and all kind of observational studies. It also regulates the organization of the Comissão de Ética para a Investigação Clínica / National Ethics Committee for Clinical Research (CEIC).

(2) Law 73/2015 of 27th July is an amendment to Law 21/2014 and sets the conditions in which monitors, auditors and inspectors have access to the registries of clinical studies’ participants.

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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