Clinical evaluation
The clinical evaluation is the analysis and evaluation of clinical data on a specific medical device with the aim of demonstrating its performance and safety in clinical application. It is based on clinical data from scientific literature and / or clinical trials.
The clinical evaluation must be differentiated from the clinical study / clinical trial . In Europe it is part of the conformity assessment procedure for medical devices that leads to CE marking .
Legal basis
The requirements for clinical evaluation come from Annex X of Directive 93/42 / EEC on medical devices and a corresponding guideline of the European Commission for medical device manufacturers, notified bodies and authorities (MEDDEV 2.7 / 1 June 2016). The MEDDEV document is based on a document of the Global Harmonization Task Force (GHTF; now IMDRF ) - an international organization - which means that terms and procedures do not always meet the European understanding of clinical evaluation. This is to be changed in revision 4.
In Germany, the clinical evaluation is mentioned in Section 19 (1) of the Medical Devices Act (MPG), which implements the content of the European Medical Device Directive nationally.
Web links
- MEDDEV 2.7 / 1 revision 4 - Guidelines on Medical Devices. Archived from the original on July 2, 2018 ; accessed on March 9, 2019 (English).
Individual evidence
- ↑ Guidance - European Commission. In: ec.europa.eu. Retrieved July 7, 2016 .