Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The placing on the market of in vitro diagnostic medical devices under the old and new legal situation with special consideration of the possibility of a special authorization - Legal basis and Regulatory Aspects -

Syed Saadi Manzoor (Abschlußjahr: 2023)

Summary
Language: English
This thesis provides an overview of the regulatory framework for in-vitro medical devices in the European Union and member states as well as in Germany. In most of the cases good disease management and clinical treatment is based on the correct data provided by the IVDs. In contrast to life saving drug or medical devices, in-vitro diagnostic devices (IVDs) do not come in direct contact, not cause physiological or therapeutic effect, but it provides the clinical diagnosis data, which is used for further accurate treatment. In vitro diagnostics (IVDs) are not intended for the direct treatment of patients, but rather serve the purpose of providing valuable insights into the physiological functioning of the human body.
In vitro diagnostics may not necessarily result in direct adverse incident, but they may have potential risk, if their use leads to inaccurate diagnostic outcome. The transition of the Medical Device Regulation from Medical Device Directive (MDD) replaced by the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Directive (IVDD) replaced by the In Vitro Diagnostic Medical Device Regulation (IVDR) which is applicable since 26.05.2022 and it is regarded as an obligation to be transposed automatically into national legislation of European Union member states, therefore all European Union member states must abide by the new IVDR. The new regulation addresses the gaps in terms of regulatory concerns in the former IVDD and because of this some additional obligations introduced for the market authorization of In vitro medical devices in the European Union. Implementation of stricter new regulatory standards for medical devices is necessary for reliable and beneficial products for the end-user. Manufacturers must adhere to all relevant regulations and maintain full Technical Documentation to ensure that the good Quality Management System is in place and for this they must adhere to the standards set out by the QMS to confirm that their products are safe and performs as expected. The first step in the process is the manufacturer determining if the product is regulated as a medical device, what risk category it falls under, and what kind of device it is. From initial concept to post-market obligations, the life cycle of a medical device is affected by compliance requirements. The Thesis also illustrates the emergency approval in compliance to the regulatory procedure of the In vitro diagnostic devices to manufacture ensure safe product and its rapid availability on the market for the safety and well-being of the population.