Interventional clinical studies of medical devices:
European 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 Community Directives 93/42/EEC of June 14 and 90/385/EEC of June 20, in their current versions, must be followed in clinical research with medical devices and active implantable medical devices, respectively. These Directives establish the rights and duties of sponsors, investigators, 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 Directives.
- Directive 93/42/EEC of the Council of June 14 - Medical devices
- Directive 90/385/EEC of the Council of June 20 - Active implantable medical devices
- MEDDEV 2.7/1 rev.3: Clinical evaluation: Guide for manufacturers and notified bodies
- MEDDEV 2.7/2: Guide for Competent Authorities in making an assessment of clinical investigation notification
- MEDDEV 2.7/3: Clinical investigations: Serious adverse event reporting
- MEDDEV 2.7/4: Clinical investigations: Guide for manufacturers and notified bodies
- MEDDEV 2.12/2 rev.2: Post market clinical follow-up studies