Legislation and guidelines

 

In order to protect the health and ensure the safety of patients, users and third parties, and for the free movement of medical devices within the EU, in accordance with the ethical recommendations from the World Health Organization (contained in the Declaration of Helsinki) and European Union, the regulatory requirements stated in the Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, in their current versions, must be followed in clinical research with medical devices. This Regulation establish the rights and duties of sponsors, competent authorities and subjects in the research.

The conduct of clinical investigation with medical devices is widely detailed in the standard EN ISO 14155 - Clinical investigation of medical devices for human subjects: Good clinical practice, that presumes compliance with the requirements for clinical investigation described in the above mentioned Regulation.

 

Regulations

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 - on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

 

National Legislation

  • Lei n.º 71/2025, de 22 de dezembro - Procede à execução, na ordem jurídica interna, dos Regulamentos (UE) 2017/745 e 2017/746, na parte relativa à investigação clínica e ao estudo de desempenho de dispositivos médicos

 

Other related legislation

 

Guidelines

More guidelines (European Commission)