Medical device legislation amendment and new legal obligations

2017/745 (MDR) The Medical Device Regulation, prepared by the EU Commission on medical devices was published in the Official Journal of the European Union and entered into force on 25.05.2017 and has been valid since 26.05.2021. In this context, many new obligations for manufacturers, importers and distributors have been defined in the relevant medical device regulations, and new regulations and updates have been made on subjects such as classification, conformity assessment routes, clinical evaluation, and single device tracking. In line with the new regulation, it includes information on whether there are changes in the classification rules of medical devices, device definition and specifications, information to be provided by the manufacturer, design and manufacturing information, general safety and performance requirements, benefit-risk analysis and risk management, clinical evaluation, product validation and validation. technical documentation needs to be prepared again. With this thesis, information about the important changes in the new medical device regulation was given and checklists that are thought to be useful for medical device manufacturers were prepared. Thus, it is aimed to create an enlightening resource for the producers in the process of legislative change.