Masterarbeit

Clinical Evaluation of light-cure resin modified Dental Composite according to MDR 745/2017

Dr. Irina Anusca (2023)

Summary
Language: English
MEDDEV 2.7/1 rev. 3 was replaced with a revised 4th edition in June 2016. In May 2017, EU Regulation 2017/745 (Medical Device Regulation, MDR) was published and came into force. The transition from MDD to MDR is well underway and has a major effect on numerous medical devices and their corresponding clinical evaluations. The EU MDR requires more stringent clinical evidence for medical device manufacturers than previous guidance (93/42/EEC, Medical Device Directive, MDD and Directive 90/385/EEC (for active implantable medical devices)). The clinical evaluation is an essential part of the conformity assessment procedure for CE marking and be must performed before the approval and the placing on the market. In the MDR, clinical evaluation is regulated in Article 61 and Annex XIV, and the term itself is also defined in the definitions. Basically the clinical evaluation should still be able to be based on existing clinical data.
The aim of this master thesis is to perform a clinical evaluation of a light-cure resin modified dental composite (risk class 2a) in order to provide an overview of the practical implementation of the new requirements of the MDR 745/2017 regulation. The objectives of this clinical evaluation report is to summarize the assessment and the evaluation clinical data pertaining to the subject medical device in order to demonstrate its clinical safety and performance; to evaluate the clinical benefits and the acceptability of the benefit/risk ratio, associated with the intended use of the subject device, to summarize the acceptability of side-effects. Another aspect is to summarize literature pertaining to similar devices in the market to verify the performance of medical device subject and finally to provide a conclusion of the clinical safety of the device and need of PMCF activities.
Pages 57
Annexes: 8, Pages 8