Masterarbeit

Medical device safety reporting in clinical investigations and PMCF studies under the new MDR - A comparison to the current German legislation

Dr. Anja von Au (2019)

Summary
Language: English
With the adoption of the Medical Device Regulation 2017/45 (MDR) in April 2017 the legislation for medical devices will be harmonized in the European member states and will be the new gold standard for the medical device industry. All medical devices still have to undergo a conformity assessment and has to fulfil the ‘General Safety and Performance Requirements’ but they must also show an expected clinical benefit. To meet these essential requirements all medical devices, have to undergo a clinical evaluation. Furthermore, post-market surveillance with post-market clinical follow-up (PMCF) is now mandatory and for implantable and class III devices the manufacturer has to draw up a summary of safety and clinical performance.
One key aspect to meet all the mentioned demands is to collect clinical data for the respective medical device. The most relevant sources of clinical data are clinical investigations. The MDR has extended the terminology and the requirements to conduct clinical investigations in contrary to the Medical Device Directive 93/42/EEC (MDD), and PMCF studies are now mandatory, too. This master thesis focuses on the safety reporting process in clinical investigations and PMCF studies. A comparison between the current German legislation, the existing European guidelines (MEDDEV) and harmonized standards (ISO 14155:2011) with the MDR will be performed. The thesis includes an overview of the new introduced terminology and highlights the changes in adverse event and device deficiency reporting in clinical investigations. Additionally, the regulatory framework for incident reporting in PMCF studies will be discussed.
Pages: 41