Clinical studies of medical devices
A clinical study of a medical device is any medical study with medical devices or its respective accessories, which integrates the scope of the Decree-Law No. 145/2009 of June 17, and whose purpose includes:
- To verify the level of performance of the device; or
- To determine any undesirable side effects in normal using conditions and to assess whether there are risks in function of the device's intended use according to the legis artis; or;
- To conduct the post marketing clinical follow-up.
Article 2 of Law No. 21/2014 of April 16
An interventional clinical study of a medical device is any research that, besides the above mentioned, also includes a change, influence or programming of the healthcare, behavior or knowledge of the subjects or caregivers, in order to discover or verify the health effects arising from the use of a medical device.